Roxee Medication Guide

Tulathromycin

Medication reference facts with explicit FDA-approval, off-label, source-limited, and safety context. Roxee does not sell, prescribe, or dispense medications.

Both Reference complete Livestock/food-animal use Rx required Liquid (Solution) Multiple FDA labelers Official label facts Owner quick guide first

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Food-animal or livestock record. This source record is for livestock or food-animal use, not a dog/cat medication profile. Food-animal rules, withdrawal intervals, and residue restrictions may apply. Do not start, stop, or change treatment without your veterinarian.

Data freshness

Reference facts

Reference refreshed

Sep 21, 2026, 10:06 a.m.

These are the reference facts Roxee uses on browse cards and quick facts.

FDA applications

FDA application data refreshed

Sep 21, 2026, 10:01 a.m.

Sponsor, product, and application records imported from Animal Drugs @ FDA.

Safety reports

Safety data refreshed

Sep 18, 2026, 10:02 a.m.

openFDA reaction terms and case summaries are supporting evidence, not proof of causality.

Source timing details

Reference facts: Source Roxee | Refreshed Sep 21, 2026, 10:06 AM UTC
The reference fact projection used for browse cards and quick facts.
Animal Drugs @ FDA: Source FDA | Refreshed Sep 21, 2026, 10:00 AM UTC
Applications/products are imported from FDA export data.
Animal Drugs @ FDA previews: Source FDA | Refreshed Sep 1, 2026, 12:26 PM UTC
Label highlights/doc links are fetched from FDA preview endpoints.
Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Sep 21, 2026, 10:01 AM UTC
Package/product NDCs from FDA’s electronic listing directory (XLS).
openFDA reaction terms: Source FDA openFDA | Refreshed Sep 21, 2026, 10:05 AM UTC
openFDA case summaries: Source FDA openFDA | Refreshed Sep 21, 2026, 10:05 AM UTC

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Tulathromycin

Drug type: Food-animal record • Branded profile • Livestock/food-animal use

Both Liquid (Solution) Rx required 100% reference complete

Species: Both

Approval status: Food-animal or livestock record. This source record is for livestock or food-animal use, not a dog/cat medication profile. Food-animal rules, withdrawal intervals, and residue restrictions may apply.

Medication Snapshot

Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.

Tulathromycin

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae ; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed. For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis . For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis, and control of pyrexia associated with BRD in beef steers, beef heifers, beef calves 2 months of age and older, beef bulls, dairy bulls, and replacement dairy heifers. Species commonly shown: Both, Suckling Calves, Dairy Calves, Veal Calves.

Generic name

Tulathromycin

Brand names

Draxxin®, Draxxin® 25 Injectable Solution, MACROSYN™, Increxxa™ 25

Manufacturer

Multiple FDA labelers

Species

Both, Suckling Calves, Beef, Dairy

Dosage forms

Liquid (Solution), Injectable Solution

Prescription

Prescription required

Completeness

100%

Validation

Complete

Brand names

Draxxin® Draxxin® 25 Injectable Solution MACROSYN™ Increxxa™ 25 Increxxa™ Tulissin® 25 Tulissin® 100 TULAVEN™ 100 TULAVEN™ 25 AROVYN™ Tulieve® RESPIRmycin™ Tulathromycin Injection RESPIRmycin™ 25 Tulaject™ 100 Tulaject™ MACROSYN® 25 Arovyn Increxxa VACASAN RESPIRmycin Tulieve RESPIRmycin 25 Draxxin Tulissin 100 VACASAN 25 Increxxa 25 Tulissin 25 Macrosyn Draxxin 25 TULATHROMYCIN

Dosage forms

Liquid (Solution) Injectable Solution

Indications / Uses

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae , Pasteurella multocida , Bordetella bronchiseptica , Haemophilus parasuis , and Mycoplasma hyopneumoniae ; and for the control of SRD associated with Actinobacillus pleuropneumoniae , Pasteurella multocida , and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed. For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica , Pasteurella multocida , Histophilus somni , and Mycoplasma bovis . For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica , Pasteurella multocida , Histophilus somni , and Mycoplasma bovis , and control of pyrexia associated with BRD in beef steers, beef heifers, beef calves 2 months of age and older, beef bulls, dairy bulls, and replacement dairy heifers.

Warnings / Contraindications

Do not inject more than 4 mL per injection site. For use in suckling calves, dairy calves, veal calves, and swine. Not for use in ruminating cattle. Not for use in Chickens or Turkeys. Federal (USA) law restricts this drug to useby or on the order of a licensed veterinarian. Do not inject more than 11.5 mL per injection site. For use in suckling calves, dairy calves, veal calves, and swine. Not for use in ruminating cattle. Not for use in Chickens or Turkeys. Federal (USA) law restricts this drug to useby or on the order of a licensed veterinarian.

Do not inject more than 4 mL per injection site. For use in suckling calves, dairy calves, veal calves, and swine. Not for use in ruminating cattle. Not for use in Chickens or Turkeys. Federal (USA) law restricts this drug to useby or on the order of a licensed veterinarian. Do not inject more than 11.5 mL per injection site. For use in suckling calves, dairy calves, veal calves, and swine. Not for use in ruminating cattle. Not for use in Chickens or Turkeys. Federal (USA) law restricts this drug to useby or on the order of a licensed veterinarian.

Side Effects

Top reported reactions (openFDA): Coughing up blood, Cutaneous emphysema, Dyspnoea, Injection site reaction NOS, Lack of efficacy (bacteria) - NOS, Lack of efficacy - NOS.

FAQ

Both, Suckling Calves, Dairy Calves, Veal Calves, Beef, Dairy, non-lactating, Beef And Non-Lactating Dairy, Dairy calves, Suckling calves, Veal calves

Yes. Roxee shows this as prescription-only.

Liquid (Solution), Injectable Solution

Related Conditions

Conjunctivitis Pneumonia (aspiration, bacterial, viral)

Source Transparency

Verified source: https://www.roxee.ai/meds/
Verified source: https://animaldrugsatfda.fda.gov
Verified source: https://animaldrugsatfda.fda.gov/adafda/views/#/search
Verified source: https://api.fda.gov/animalandveterinary/event.json
Verified source: https://www.roxee.ai/conditions/
Verified source: https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/792
Last refreshed: Sep 21, 2026, 10:06 a.m.
Last verified: Feb 12, 2026, 10:44 p.m.
Validation status: Complete

Add to My Pet's Medications

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Pet Owner Quick Guide

Start here first for the safest next-step summary before the deeper medication detail.

Used for:

MACROSYN® 25 Injectable Solution is indicated for the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae , Pasteurella multocida , Bordetella bronchiseptica , Haemophilus parasui...

Dosing note:

Exact dosing depends on your pet's species, weight, and health status. Use your veterinarian's instructions for the exact dose and schedule.

What to watch for:

Do not inject more than 4 mL per injection site
For use in suckling calves, dairy calves, veal calves, and swine
Not for use in ruminating cattle
Not for use in Chickens or Turkeys
Federal (USA) law restricts this drug to useby or on the order of a licensed veterinarian
Do not inject more than 11.5 mL per injection site
Vomiting (1 reports)
Vocalisation (1 reports)
trouble breathing (1 reports)

When to call the vet:

Repeated vomiting or diarrhea.
Severe lethargy (hard to wake, very low energy).
Collapse or fainting.
Facial swelling or hives.
Blood in vomit or stool.

What to tell or ask your vet today:

Is this medicine the right fit for my pet’s current symptoms?
Which warning signs mean I should call back right away?
How should I handle missed doses or refusal to take the medicine?

Next actions

Talk to a Vet / Find a Vet Near You Save to pet meds Share page Review report evidence

Research brief

Medication Research Insights

A source-aware map of what to know, what is uncertain, and what to verify with your veterinarian.

Source Backed Signals

What to know

Evidence-backed context Limited

Roxee has limited cited overview evidence for Tulathromycin; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2026-US-004960

Safety signal coverage Reported signals

30 tracked reaction signals; 26 reported cases; 19 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2026-US-004960

Interpretation guardrail Not causation

Adverse-event reports help form a watch list, but they do not prove the medication caused the reaction and they are not a risk ranking between medications.

Evidence tension

Stronger signal Label / review

Official labels, package inserts, and reviewed summaries carry more weight than isolated reports.

Source: openFDA case USA-USFDACVM-2026-US-004960

Weaker signal Reported data

Case reports and openFDA terms are useful for pattern awareness, but they are incomplete, can include multiple exposures, and do not estimate an individual pet's probability of harm.

Reaction signal map

Most reported reactions Top terms

Vomiting (1 reports), Vocalisation (1 reports), Trouble breathing (dyspnea) (1 reports), Tiredness (lethargy) (1 reports), Seizure NOS (1 reports)

Body systems represented Signal grouping

Digestive (1), Neurologic (4), Effectiveness (2), Other (23)

Explore supporting adverse reports

Species and breed lens

Species represented in reports Species lens

Dog (18 reports), Cat (12 reports)

Breed metadata in reports Metadata only

Domestic Shorthair (1), ['Schnauzer (unspecified)', 'Dog (unknown)'] (1), Schnauzer - Miniature (1). These are report metadata, not proof that a breed is at higher risk.

What your vet may verify

Fit for this patient Vet check

Verify whether Tulathromycin fits the pet's species, current diagnosis, age, weight, organ status, pregnancy/lactation status, and concurrent medications.

Evidence limitations Evidence review

Separate label-backed warnings from adverse-event reports and owner observations before changing the plan.

What to watch next

Watch list Owner-safe

Do not inject more than 4 mL per injection site, For use in suckling calves, dairy calves, veal calves, and swine, Not for use in ruminating cattle, Not for use in Chickens or Turkeys, Federal (USA) law restricts this drug to useby or on the order of a licensed veterinarian

Call sooner if Escalation

Repeated vomiting or diarrhea. Severe lethargy (hard to wake, very low energy). Collapse or fainting.

Bottom line: Use this Tulathromycin brief as a structured watch list and source map, not as a reason to start, stop, or change treatment without your veterinarian.

Vet source depth

openFDA case USA-USFDACVM-2026-US-004960 · adverse_reaction · adverse reactions
Contraindication source · fda_animal_drugs · warnings contraindications
FDA application profile · official_label · quick facts
FDA application profile · official_label · quick facts
Medication usage source · fda_animal_drugs · quick facts
FOI · document · documents
SPL · document · documents
FOI · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

Updated: February 12, 2026, 10:44 PM UTC

Sources:

FDA application profile · official_label
FDA application profile · official_label
Medication usage source · fda_animal_drugs
Tulathromycin Injection · official_label
openFDA case USA-USFDACVM-2026-US-004960 · adverse_reaction

Safety & side effects

Side effects to monitor:

Do not inject more than 4 mL per injection site
For use in suckling calves, dairy calves, veal calves, and swine
Not for use in ruminating cattle
Not for use in Chickens or Turkeys
Federal (USA) law restricts this drug to useby or on the order of a licensed veterinarian

Most reported reactions:

Vomiting (1 reports)
Vocalisation (1 reports)
Trouble breathing (dyspnea) (1 reports)

Explore reported case details

Emergency warning signs:

Repeated vomiting or diarrhea.
Severe lethargy (hard to wake, very low energy).
Collapse or fainting.
Facial swelling or hives.

Talk to a Vet / Find a Vet Near You Start Symptom Intake

Vet Fast Scan

Source-backed clinical checkpoints for quick review.

FDA-labeled species

Beef, Beef And Non-Lactating Dairy, Dairy, Dairy calves, Suckling Calves, Suckling calves, Veal calves

Indication / use

MACROSYN® 25 Injectable Solution is indicated for the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae , Pasteurella multocida , Bordet…

Form / route / dose

Form: Injectable Solution, Liquid (Solution)
Route: Intramuscular, Subcutaneous
Confirm product label and patient-specific plan.

Warnings

High: Do not inject more than 4 mL per injection site. For use in suckling calves, dairy calves, veal calves, and swine. Not …

Adverse-event caveat

openFDA adverse-event cases are reported signals. They are not verified, do not prove causation, and do not estimate a pet's individual risk.

Source docs

Quick Facts

Official label facts first, then secondary summaries. Marketing content is separated below.

Species: Both

Manufacturer: Multiple FDA labelers

Form: Injectable Solution, Liquid (Solution)

Identifiers:

ANADA: 200657 ANADA: 200665 ANADA: 200666 ANADA: 200668 ANADA: 200669 ANADA: 200711 ANADA: 200712 ANADA: 200715 ANADA: 200723 ANADA: 200730 ANADA: 200742 ANADA: 200745 ANADA: 200773 ANADA: 200774 ANADA: 200844 NADA: 141244 NADA: 141349 NADA: 141543 NDC Package: 0061-6607-02 NDC Package: 0061-6607-03

Source metadata:

https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/200844 · official_label · FDA application profile
https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/141244 · official_label · FDA application profile
https://animaldrugsatfda.fda.gov · fda_animal_drugs · Medication usage source

Warnings / Contraindications

High: Do not inject more than 4 mL per injection site. For use in suckling calves, dairy calves, veal calves, and swine. Not for use in ruminating cattle. Not for use in Chickens or Turkeys. Federal (USA) law restricts this drug to useby or on the order of a licensed veterinarian. Do not inject more than 11.5 mL per injection site. For use in suckling calves, dairy calves, veal calves, and swine. Not for use in ruminating cattle. Not for use in Chickens or Turkeys. Federal (USA) law restricts this drug to useby or on the order of a licensed veterinarian.

Source metadata:

https://animaldrugsatfda.fda.gov · fda_animal_drugs · Contraindication source

Adverse Reactions

Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.

Reported case explorer

Filter stored openFDA reports by pet and report attributes. Counts describe reports in this data set, not risk.

Clear filters

openFDA adverse-event cases are reported signals. They are not verified, do not prove causation, and do not estimate a pet's individual risk.

Stored reports

Matching reports

Active filters

Selected filters

Reaction: Medication error NOS Clear Body system: Neurologic Clear

Species

Breed

Size / weight

Age

Sex

Seriousness

Outcome

Reaction

Body system

Region

Received after

Received before

Reset

Drill into common report signals

Medication error NOS (2) Agglutination test, positive (1) Decreased packed cell volume (PCV) (1) General illness (1) Other (3) Digestive (1) Neurologic (1)

No stored openFDA reports match the selected filters. openFDA adverse-event cases are reported signals. They are not verified, do not prove causation, and do not estimate a pet's individual risk.

Tap or hover a reaction to see what it means in plain language.

Tracked signals

Reported cases

Serious reports

Species represented

Grouped by Body System

Digestive (1) · Vomiting Neurologic (4) · Tiredness (lethargy), Seizure NOS, Neurological signs NOS Effectiveness (2) · Lack of efficacy - NOS, Lack of efficacy (bacteria) - NOS Other (23) · Vocalisation, Trouble breathing (dyspnea), Pneumothorax

Most Reported Reactions

Body system	Cases	Species	Serious cases
Digestive	1	Dog	1
Other	1	Cat	1
Other	1	Dog	1
Neurologic	1	Dog	1
Neurologic	1	Dog	1
Other	1	Dog	1
Other	1	Dog	1
Neurologic	1	Cat	1

Species coverage: Dog (18) Cat (12)

View detailed reaction table

Body system	Species	Seriousness	Frequency	Reports
Digestive	Dog	Serious	-	1
Other	Cat	Serious	-	1
Other	Dog	Serious	-	1
Neurologic	Dog	Serious	-	1
Neurologic	Dog	Serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Non-serious	-	1
Other	Dog	Non-serious	-	1
Other	Dog	Non-serious	-	1
Neurologic	Cat	Serious	-	1
Other	Cat	Non-serious	-	1
Effectiveness	Dog	Non-serious	-	1
Effectiveness	Dog	Non-serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Serious	-	1
Other	Cat	Serious	-	1
Other	Cat	Non-serious	-	1
Other	Cat	Serious	-	1
Other	Cat	Serious	-	1
Other	Cat	Serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Serious	-	1
Other	Cat	Serious	-	1
Other	Dog	Serious	-	1
Neurologic	Dog	Unknown	-	-
Other	Cat	Unknown	-	-
Other	Cat	Unknown	-	-
Other	Cat	Unknown	-	-

Source metadata:

https://api.fda.gov/animalandveterinary/event.json · adverse_reaction · openFDA case USA-USFDACVM-2026-US-004960

Source Documents

The most useful source links appear first; full previews and metadata stay in the veterinary/professional layer.

Use original documents to confirm product-specific warnings, ingredients, and handling details with your veterinarian.

MACROSYN® 25 SPL · SPL Draxxin® SPL · SPL Tulathromycin Injection SPL · SPL

Full source previews and metadata remain in the veterinary/professional layer.

Owner handouts

No owner handouts linked yet.

Official label / PI

No official label or package insert links yet.

SPL

FOI

MACROSYN® 25

SPL · SPL

Open original

FDA Structured Product Label

MACROSYN® 25

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor: Bimeda Animal Health Ltd.
ANADA: 200-844
Status: RX
Form: Injectable Solution
Route: Subcutaneous, Intramuscular
Species: Dairy calves • Suckling calves • Veal calves

Composition / specifications

25 mg of tulathromycin/mL

Swine

Indication

MACROSYN® 25 Injectable Solution is indicated for the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (1 mL/22 lb) body weight (BW). Do not inject more than 4 mL per injection site.

Suckling Calves, Dairy Calves, and Veal Calves

Indication

BRD – MACROSYN® 25 Injectable Solution is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1 mL/22 lb) body weight (BW). Do not inject more than 11.5 mL per injection site.

Draxxin®

SPL · SPL

Open original

FDA Structured Product Label

Draxxin®

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor: Zoetis Inc.
NADA: 141-244
Status: RX
Form: Liquid (Solution)
Route: Intramuscular, Subcutaneous
Species: Suckling Calves • Beef • Dairy

Composition / specifications

Each milliliter of solution contains 100 milligrams (mg) tulathromycin.

Swine

Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, P. multocida, Bordetella bronchiseptica, and H. parasuis and Mycoplasma hyopneumoniae; and for control of SRD associated with Actinobacillus pleuropneumoniae, P. multocida, and M. hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Administer 2.5 mg per kilogram (0.25 mL/22 lb) body weight as a single intramuscular injection in the neck.

Limitations

Do not inject more than 2.5 mL per injection site. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Cattle (Beef and Non-Lactating Dairy)

Indication

For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

Dosage

Administer 2.5 mg per kilogram (1.1 mL/100 lb) body weight as a single subcutaneous injection in the neck.

Limitations

Do not use in female dairy cattle 20 months of age or older. Do not inject more than 10 mL per injection site. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Indication

For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.

Dosage

Administer 2.5 mg per kilogram (1.1 mL/100 lb) body weight as a single subcutaneous injection in the neck.

Limitations

Do not use in female dairy cattle 20 months of age or older. Do not inject more than 10 mL per injection site. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; for the control of respiratory disease in cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis; and for the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.

Dosage

Administer 2.5 mg per kilogram (1.1 mL/100 lb) body weight as a single subcutaneous injection in the neck.

Limitations

Do not use in female dairy cattle 20 months of age or older. Do not inject more than 10 mL per injection site. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Cattle (Suckling Calves, Dairy Calves, and Veal Calves)

Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

Dosage

Administer 2.5 mg per kilogram (1.1 mL/100 lb) body weight as a single subcutaneous injection in the neck.

Limitations

Do not inject more than 10 mL per injection site. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Tulathromycin Injection

SPL · SPL

Open original

FDA Structured Product Label

Tulathromycin Injection

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor: Hikma Pharmaceuticals USA, Inc.
ANADA: 200-742
Status: RX
Form: Injectable Solution
Route: Intramuscular, Subcutaneous
Species: Suckling Calves • Beef And Non-Lactating Dairy

Composition / specifications

100 mg of tulathromycin/mL

Beef cattle, non-lactating dairy cattle, suckling calves, dairy calves and veal calves

Indication

BRD – Tulathromycin Injection is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

IBK – Tulathromycin Injection is indicated for the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.

Foot Rot – Tulathromycin Injection is indicated for the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

Suckling Calves, Dairy Calves, and Veal Calves

BRD – Tulathromycin Injection is indicated for the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Swine

Indication

Tulathromycin Injection is indicated for the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (0.25 mL/22 lb) BW. Do not inject more than 2.5 mL per injection site.

Tulaject™

SPL · SPL

Open original

FDA Structured Product Label

Tulaject™

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor: Cronus Pharma Specialities India Private Ltd.
ANADA: 200-774
Status: RX
Form: Injectable Solution
Route: Intramuscular, Subcutaneous
Species: Suckling Calves

Composition / specifications

25 mg of tulathromycin/mL

Swine

Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (1 mL/22lb) body weight (BW). Do not inject more than 4 mL per injection site.

Suckling Calves, Dairy Calves, and Veal Calves

Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1 mL/22lb) BW. Do not inject more than 11.5 mL per injection site.

Tulaject™ 100

SPL · SPL

Open original

FDA Structured Product Label

Tulaject™ 100

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor: Cronus Pharma Specialities India Private Ltd.
ANADA: 200-773
Status: RX
Form: Injectable Solution
Route: Subcutaneous, Intramuscular
Species: Suckling Calves • Beef And Non-Lactating Dairy

Composition / specifications

100 mg of tulathromycin/mL

Beef and Non-Lactating Dairy Cattle

Indication

BRD- For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.
IBK- For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis
Foot Rot- For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Suckling Calves, Dairy Calves, and Veal Calves

Indication

Indication

BRD – For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

IBK – For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.

Foot Rot – For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Suckling calves, dairy calves, and veal calves

Indication

For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Swine

Indication

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (0.25 mL/22 lb) BW. Do not inject more than 2.5 mL per injection site.

Tulieve®

SPL · SPL

Open original

FDA Structured Product Label

Tulieve®

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor: Norbrook Laboratories, Ltd.
ANADA: 200-723
Status: RX
Form: Injectable Solution
Route: Subcutaneous, Intramuscular
Species: Suckling Calves • Beef And Non-Lactating Dairy

Composition / specifications

100 mg of tulathromycin/mL

Beef and Non-Lactating Dairy Cattle

Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

For the treatment of infectious bovine keratoconjunctivitis associated with Moraxella bovis.

For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Suckling Calves, Dairy Calves, and Veal Calves

Indication

For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Swine

Indication

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (0.25 mL/22 lb) BW. Do not inject more than 2.5 mL per injection site.

AROVYN™

SPL · SPL

Open original

FDA Structured Product Label

AROVYN™

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor: Intervet, Inc.
ANADA: 200-715
Status: RX
Form: Injectable Solution
Route: Subcutaneous, Intramuscular
Species: Suckling Calves • Beef And Non-Lactating Dairy

Composition / specifications

100 mg of tulathromycin/mL

Beef and Non-Lactating Dairy Cattle

Indication

For the treatment of infectious bovine keratoconjunctivitis associated with Moraxella bovis.

For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Suckling Calves, Dairy Calves, and Veal Calves

Indication

For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Swine

Sponsor: Ceva Sante Animale
ANADA: 200-711
Status: RX
Form: Injectable Solution
Route: Subcutaneous, Intramuscular
Species: Suckling Calves • Beef And Non-Lactating Dairy • Dairy calves

Composition / specifications

100 mg of tulathromycin/mL

Beef and Non-Lactating Dairy Cattle

Indication

BRD: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

IBK: For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.

Foot Rot: For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Suckling Calves, Dairy Calves, and Veal Calves

Indication

For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Swine

Sponsor: Virbac AH, Inc.
ANADA: 200-669
Status: RX
Form: Injectable Solution
Route: Subcutaneous, Intramuscular
Species: Suckling Calves • Beef And Non-Lactating Dairy

Composition / specifications

100 mg of tulathromycin/mL

Beef and Non-Lactating Dairy Cattle

Indication

IBK: For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.

Foot Rot: For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Suckling Calves, Dairy Calves, and Veal Calves

Indication

For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Swine

Sponsor: Elanco US Inc.
ANADA: 200-666
Status: RX
Form: Injectable Solution
Route: Subcutaneous, Intramuscular
Species: Suckling Calves • Beef And Non-Lactating Dairy

Composition / specifications

100 mg of tulathromycin/mL

Beef and Non-Lactating Dairy Cattle

Indication

For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.

For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Suckling Calves, Dairy Calves, and Veal Calves

Indication

For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Swine

Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (0.25 mL/22 lb) BW. Do not inject more than 2.5 mL per injection site.

MACROSYN™

SPL · SPL

Open original

FDA Structured Product Label

MACROSYN™

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor: Bimeda Animal Health Ltd.
ANADA: 200-657
Status: RX
Form: Injectable Solution
Route: Intramuscular, Subcutaneous
Species: Suckling Calves • Beef And Non-Lactating Dairy

Composition / specifications

100 mg of tulathromycin/mL

Beef and Non-Lactating Dairy Cattle

Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.

For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb.) bodyweight (BW). Do not inject more than 10 mL per injection site.

Suckling Calves, Dairy Calves, and Veal Calves

Indication

For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb.) bodyweight (BW). Do not inject more than 10 mL per injection site.

Swine

Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (0.25 mL/22 lb.) BW. Do not inject more than 2.5 mL per injection site.

Draxxin® 25 Injectable Solution

SPL · SPL

Open original

FDA Structured Product Label

Draxxin® 25 Injectable Solution

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor: Zoetis Inc.
NADA: 141-349
Status: RX
Form: Injectable Solution
Route: Intramuscular, Subcutaneous
Species: Suckling Calves

Composition / specifications

25 mg/mL

Swine

Indication

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/ kg (1 mL/22 lb) Body Weight (BW).

Limitations

Cattle (Calves)

https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/18874 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/19076/MACROSYN%C2%AE%2025 · document · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/794 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/793 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/2229 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/792 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/791 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/790 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/789 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/438/Draxxin%C2%AE · document · SPL

Veterinary reference (advanced)

Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.

At a Glance

Quick facts and links to official labeling and safety signals.

Data freshness

Reference facts: Source Roxee | Refreshed Sep 21, 2026, 10:06 AM UTC
The reference fact projection used for browse cards and quick facts.
Animal Drugs @ FDA: Source FDA | Refreshed Sep 21, 2026, 10:00 AM UTC
Applications/products are imported from FDA export data.
Animal Drugs @ FDA previews: Source FDA | Refreshed Sep 1, 2026, 12:26 PM UTC
Label highlights/doc links are fetched from FDA preview endpoints.
Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Sep 21, 2026, 10:01 AM UTC
Package/product NDCs from FDA’s electronic listing directory (XLS).
openFDA reaction terms: Source FDA openFDA | Refreshed Sep 21, 2026, 10:05 AM UTC
openFDA case summaries: Source FDA openFDA | Refreshed Sep 21, 2026, 10:05 AM UTC

Official (FDA)

Identity: Generic ingredient • FDA branded products available

Official FDA brands: Arovyn Draxxin Draxxin 25 Increxxa Increxxa 25 Macrosyn RESPIRmycin RESPIRmycin 25 TULATHROMYCIN Tulieve Tulissin 100 Tulissin 25 VACASAN VACASAN 25

Manufacturer mapping: Multiple FDA labelers

Case-reported brands (openFDA): MSK

Catalog species: Both • FDA-labeled species: Beef, Beef And Non-Lactating Dairy, Dairy, Dairy calves, Suckling Calves, Suckling calves, Veal calves

Rx/OTC: RX

Form/route: Injectable Solution, Liquid (Solution) • Intramuscular, Subcutaneous

Applications: ANADA 200-844 • NADA 141-244 • ANADA 200-742 • ANADA 200-774 • ANADA 200-773 • ANADA 200-745 • ANADA 200-730 • ANADA 200-723 • ANADA 200-715 • ANADA 200-665 • ANADA 200-711 • ANADA 200-712 • ANADA 200-669 • ANADA 200-668 • ANADA 200-666 • ANADA 200-657 • NADA 141-349

NDC: Packages 0061-6607-02 0061-6607-03 0061-6607-04 0061-6607-05 23243-2825-1 23243-2825-2 • Products 0061 23243 51311 54771 55529 58198

Documents: 24 (FOI: 24) • SPL: 17 • Label highlights • Official documents

Safety (openFDA)

Top reactions: Dog 7 • Cat 2 • View

Case summaries: 3 (showing 3) • View

openFDA reports are unverified and do not prove causation.

Explore

Related conditions: Conjunctivitis Pneumonia (aspiration, bacterial, viral)

Linked using: Fda_Label (0.95), Fda_Label (0.95)

Diagnosis Codes

Diagnosis-code mappings are not available for this medication yet.

Counseling and Monitoring Highlights

Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.

Owner-facing counseling points

Do not inject more than 4 mL per injection site. For use in suckling calves, dairy calves, veal calves, and swine. Not for use in ruminating cattle. Not for use in Chickens or Turkeys. Federal (USA) law restricts this drug to useby or on the order of a licensed veterinarian. Do not inject more than 11.5 mL per injection site. For use in suckling calves, dairy calves, veal calves, and swine. Not for use in ruminating cattle. Not for use in Chickens or Turkeys. Federal (USA) law restricts this drug to useby or on the order of a licensed veterinarian. (Contraindication, High)

Top reaction signals

Vomiting (1) Vocalisation (1) Trouble breathing (dyspnea) (1) Tiredness (lethargy) (1) Seizure NOS (1) Pneumothorax (1) Panting (1) Neurological signs NOS (1)

Identifiers & Packages

Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.

Identifiers

Package NDC	Product NDC	Status
0061-6607-02	0061	-
0061-6607-03	0061	-
0061-6607-04	0061	-
0061-6607-05	0061	-
23243-2825-1	23243	-
23243-2825-2	23243	-
23243-5282-1	23243	-
23243-5282-2	23243	-
23243-5282-5	23243	-
23243-5282-6	23243	-
51311-002-10	51311	-
51311-002-25	51311	-
51311-006-10	51311	-
51311-006-25	51311	-
51311-006-50	51311	-
51311-006-51	51311	-
54771-2155-1	54771	-
54771-2155-2	54771	-
54771-2155-3	54771	-
54771-2155-4	54771	-

Enriched Documents

Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.

VACASAN 25 SPL • Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
Tulissin 100 SPL • Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
Draxxin SPL • Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
RESPIRmycin 25 SPL • Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
Macrosyn SPL • Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
Arovyn SPL • Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
Increxxa 25 SPL • Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
Increxxa SPL • Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
Draxxin 25 SPL • Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
Tulieve SPL • Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
VACASAN SPL • Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
Tulissin 25 SPL • Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
RESPIRmycin SPL • Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
TULATHROMYCIN SPL • Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
FOI Summary oA 200-844 Approved August 20, 2026.pdf • FOI summary • Official • Sept. 1, 2026
FDA FOI summary for application 200844
ucm118061.pdf • FOI summary • Official • May 14, 2026
FDA FOI summary for application 141244
ucm118064.pdf • FOI summary • Official • May 14, 2026
FDA FOI summary for application 141244
ucm051496.pdf • FOI summary • Official • May 14, 2026
FDA FOI summary for application 141244
ucm051495.pdf • FOI summary • Official • May 14, 2026
FDA FOI summary for application 141244
N141244 Supp_8_28_2008.pdf • FOI summary • Official • May 14, 2026
FDA FOI summary for application 141244
UCM196106.pdf • FOI summary • Official • May 14, 2026
FDA FOI summary for application 141244
UCM421912.pdf • FOI summary • Official • May 14, 2026
FDA FOI summary for application 141244
FOI Summary oA 200-742 Approved February 25, 2025.pdf • FOI summary • Official • Feb. 26, 2025
FDA FOI summary for application 200742
FOI Summary oA 200-774 Approved September 10, 2024.pdf • FOI summary • Official • Oct. 1, 2024
FDA FOI summary for application 200774
FOI Summary oA 200-773 Approved September 5, 2024.pdf • FOI summary • Official • Oct. 1, 2024
FDA FOI summary for application 200773
FOI Summary oA 200-745 Approved March 21, 2023.pdf • FOI summary • Official • April 3, 2023
FDA FOI summary for application 200745
FOI Summary oA 200-730 Approved November 4, 2022.pdf • FOI summary • Official • Dec. 1, 2022
FDA FOI summary for application 200730
FOI Summary oA 200-723 Approved March 23, 2022.pdf • FOI summary • Official • April 1, 2022
FDA FOI summary for application 200723
FOI Summary oA 200-715 Approved February 9, 2022.pdf • FOI summary • Official • March 1, 2022
FDA FOI summary for application 200715
FOI Summary oA 200-665 Approved February 7, 2022.pdf • FOI summary • Official • March 1, 2022
FDA FOI summary for application 200665
FOI Summary oA 200-712 Approved November 3, 2021.pdf • FOI summary • Official • Dec. 1, 2021
FDA FOI summary for application 200712
FOI Summary oA 200-711 Approved November 1, 2021.pdf • FOI summary • Official • Dec. 1, 2021
FDA FOI summary for application 200711
FOI Summary oA 200-669 Approved November 15, 2021.pdf • FOI summary • Official • Dec. 1, 2021
FDA FOI summary for application 200669
FOI Summary oA 200-668 Approved November 12, 2021.pdf • FOI summary • Official • Dec. 1, 2021
FDA FOI summary for application 200668
FOI Summary oN 141-543 Approved June 1, 2021.pdf • FOI summary • Official • July 1, 2021
FDA FOI summary for application 141543
FOI Summary oA 200-666 Approved February 18, 2021.pdf • FOI summary • Official • March 1, 2021
FDA FOI summary for application 200666
FOI Summary oA 200-657 Approved February 18, 2021.pdf • FOI summary • Official • March 1, 2021
FDA FOI summary for application 200657
UCM374308.pdf • FOI summary • Official • April 1, 2019
FDA FOI summary for application 141349
UCM436589.pdf • FOI summary • Official • April 1, 2019
FDA FOI summary for application 141349

Data Sources & Change Log

Every non-trivial field is expected to include provenance and update timestamps.

Official 90 Clinical 69 Manufacturer 0 Marketing 0

Current Field Facts

side_effects: Top reported reactions (openFDA): Coughing up blood, Cutaneous emphysema, Dyspnoea, Injection site reaction NOS, Lack of efficacy (bacteria) - NOS, Lack of eff… (Clinical, 2026-07-02)
side_effects: Top reported reactions (openFDA): Coughing up blood, Cutaneous emphysema, Dyspnoea, Injection site reaction NOS, Lack of efficacy (bacteria) - NOS, Lack of eff… (Clinical, 2026-07-01)
side_effects: Top reported reactions (openFDA): Coughing up blood, Cutaneous emphysema, Dyspnoea, Injection site reaction NOS, Lack of efficacy (bacteria) - NOS, Lack of eff… (Clinical, 2026-07-01)
side_effects: Top reported reactions (openFDA): Coughing up blood, Cutaneous emphysema, Dyspnoea, Injection site reaction NOS, Lack of efficacy (bacteria) - NOS, Lack of eff… (Clinical, 2026-07-01)
side_effects: Top reported reactions (openFDA): Coughing up blood, Cutaneous emphysema, Dyspnoea, Injection site reaction NOS, Lack of efficacy (bacteria) - NOS, Lack of eff… (Clinical, 2026-06-30)
side_effects: Top reported reactions (openFDA): Coughing up blood, Cutaneous emphysema, Dyspnoea, Injection site reaction NOS, Lack of efficacy (bacteria) - NOS, Lack of eff… (Clinical, 2026-06-25)
side_effects: Top reported reactions (openFDA): Coughing up blood, Cutaneous emphysema, Dyspnoea, Injection site reaction NOS, Lack of efficacy (bacteria) - NOS, Lack of eff… (Clinical, 2026-06-24)
side_effects: Top reported reactions (openFDA): Coughing up blood, Cutaneous emphysema, Dyspnoea, Injection site reaction NOS, Lack of efficacy (bacteria) - NOS, Lack of eff… (Clinical, 2026-06-24)
side_effects: Top reported reactions (openFDA): Coughing up blood, Cutaneous emphysema, Dyspnoea, Injection site reaction NOS, Lack of efficacy (bacteria) - NOS, Lack of eff… (Clinical, 2026-06-23)
side_effects: Top reported reactions (openFDA): Coughing up blood, Cutaneous emphysema, Dyspnoea, Injection site reaction NOS, Lack of efficacy (bacteria) - NOS, Lack of eff… (Clinical, 2026-06-22)
side_effects: Top reported reactions (openFDA): Coughing up blood, Cutaneous emphysema, Dyspnoea, Injection site reaction NOS, Lack of efficacy (bacteria) - NOS, Lack of eff… (Clinical, 2026-06-22)
side_effects: Top reported reactions (openFDA): Coughing up blood, Cutaneous emphysema, Dyspnoea, Injection site reaction NOS, Lack of efficacy (bacteria) - NOS, Lack of eff… (Clinical, 2026-06-21)
side_effects: Top reported reactions (openFDA): Coughing up blood, Cutaneous emphysema, Dyspnoea, Injection site reaction NOS, Lack of efficacy (bacteria) - NOS, Lack of eff… (Clinical, 2026-06-20)
side_effects: Top reported reactions (openFDA): Coughing up blood, Cutaneous emphysema, Dyspnoea, Injection site reaction NOS, Lack of efficacy (bacteria) - NOS, Lack of eff… (Clinical, 2026-06-13)
side_effects: Top reported reactions (openFDA): Coughing up blood, Cutaneous emphysema, Dyspnoea, Injection site reaction NOS, Lack of efficacy (bacteria) - NOS, Lack of eff… (Clinical, 2026-06-12)
side_effects: Top reported reactions (openFDA): Coughing up blood, Cutaneous emphysema, Dyspnoea, Injection site reaction NOS, Lack of efficacy (bacteria) - NOS, Lack of eff… (Clinical, 2026-06-12)
side_effects: Top reported reactions (openFDA): Coughing up blood, Cutaneous emphysema, Dyspnoea, Injection site reaction NOS, Lack of efficacy (bacteria) - NOS, Lack of eff… (Clinical, 2026-06-11)
side_effects: Top reported reactions (openFDA): Coughing up blood, Cutaneous emphysema, Dyspnoea, Injection site reaction NOS, Lack of efficacy (bacteria) - NOS, Lack of eff… (Clinical, 2026-06-11)
side_effects: Top reported reactions (openFDA): Coughing up blood, Cutaneous emphysema, Dyspnoea, Injection site reaction NOS, Lack of efficacy (bacteria) - NOS, Lack of eff… (Clinical, 2026-06-10)
side_effects: Top reported reactions (openFDA): Coughing up blood, Cutaneous emphysema, Dyspnoea, Injection site reaction NOS, Lack of efficacy (bacteria) - NOS, Lack of eff… (Clinical, 2026-06-08)

Recent Revisions

side_effects updated 2026-09-21 10:06 by etl_backfill • Backfilled from existing medication fields
contraindications updated 2026-09-21 10:06 by etl_backfill • Backfilled from existing medication fields
usage updated 2026-09-21 10:06 by etl_backfill • Backfilled from existing medication fields
side_effects updated 2026-09-20 10:06 by etl_backfill • Backfilled from existing medication fields
contraindications updated 2026-09-20 10:06 by etl_backfill • Backfilled from existing medication fields
usage updated 2026-09-20 10:06 by etl_backfill • Backfilled from existing medication fields
side_effects updated 2026-09-19 10:06 by etl_backfill • Backfilled from existing medication fields
contraindications updated 2026-09-19 10:06 by etl_backfill • Backfilled from existing medication fields
usage updated 2026-09-19 10:06 by etl_backfill • Backfilled from existing medication fields
side_effects updated 2026-09-18 10:06 by etl_backfill • Backfilled from existing medication fields
contraindications updated 2026-09-18 10:06 by etl_backfill • Backfilled from existing medication fields
usage updated 2026-09-18 10:06 by etl_backfill • Backfilled from existing medication fields
side_effects updated 2026-09-17 10:06 by etl_backfill • Backfilled from existing medication fields
contraindications updated 2026-09-17 10:06 by etl_backfill • Backfilled from existing medication fields
usage updated 2026-09-17 10:06 by etl_backfill • Backfilled from existing medication fields
side_effects updated 2026-09-16 10:06 by etl_backfill • Backfilled from existing medication fields
contraindications updated 2026-09-16 10:06 by etl_backfill • Backfilled from existing medication fields
usage updated 2026-09-16 10:06 by etl_backfill • Backfilled from existing medication fields
side_effects updated 2026-09-15 10:08 by etl_backfill • Backfilled from existing medication fields
contraindications updated 2026-09-15 10:08 by etl_backfill • Backfilled from existing medication fields

FDA Products & Applications (Animal Drugs @ FDA)

Official sponsor/proprietary-name/application-status records linked by active ingredient.

Product	Sponsor	Application	Status	Published
MACROSYN® 25 RX Tulathromycin Injectable Solution • Subcutaneous, Intramuscular Label highlights Official documents	Bimeda Animal Health Ltd.	ANADA 200-844	Approved	Sep 1, 2026
Draxxin® RX Tulathromycin Liquid (Solution) • Intramuscular, Subcutaneous Label highlights Official documents	Zoetis Inc.	NADA 141-244	Approved	May 14, 2026
Tulathromycin Injection RX Tulathromycin Injectable Solution • Intramuscular, Subcutaneous Label highlights Official documents	Hikma Pharmaceuticals USA, Inc.	ANADA 200-742	Approved	Feb 26, 2025
Tulaject™ RX Tulathromycin Injectable Solution • Intramuscular, Subcutaneous Label highlights Official documents	Cronus Pharma Specialities India Private Ltd.	ANADA 200-774	Approved	Oct 1, 2024
Tulaject™ 100 RX Tulathromycin Injectable Solution • Subcutaneous, Intramuscular Label highlights Official documents	Cronus Pharma Specialities India Private Ltd.	ANADA 200-773	Approved	Oct 1, 2024
RESPIRmycin™ 25 RX Tulathromycin Injectable Solution • Subcutaneous, Intramuscular Label highlights Official documents	Parnell Technologies Pty. Ltd.	ANADA 200-745	Approved	Apr 3, 2023
RESPIRmycin™ RX Tulathromycin Injectable Solution • Subcutaneous, Intramuscular Label highlights Official documents	Parnell Technologies Pty. Ltd.	ANADA 200-730	Approved	Dec 1, 2022
Tulieve® RX Tulathromycin Injectable Solution • Subcutaneous, Intramuscular Label highlights Official documents	Norbrook Laboratories, Ltd.	ANADA 200-723	Approved	Apr 1, 2022
AROVYN™ RX Tulathromycin Injectable Solution • Subcutaneous, Intramuscular Label highlights Official documents	Intervet, Inc.	ANADA 200-715	Approved	Mar 1, 2022
Increxxa™ 25 RX Tulathromycin Injectable Solution • Subcutaneous, Intramuscular Label highlights Official documents	Elanco US Inc.	ANADA 200-665	Approved	Mar 1, 2022
TULAVEN™ 100 RX Tulathromycin Injectable Solution • Subcutaneous, Intramuscular Label highlights Official documents	Ceva Sante Animale	ANADA 200-711	Approved	Dec 1, 2021
TULAVEN™ 25 RX Tulathromycin Injectable Solution • Intramuscular, Subcutaneous Label highlights Official documents	Ceva Sante Animale	ANADA 200-712	Approved	Dec 1, 2021
Tulissin® 100 RX Tulathromycin Injectable Solution • Subcutaneous, Intramuscular Label highlights Official documents	Virbac AH, Inc.	ANADA 200-669	Approved	Dec 1, 2021
Tulissin® 25 RX Tulathromycin Injectable Solution • Subcutaneous, Intramuscular Label highlights Official documents	Virbac AH, Inc.	ANADA 200-668	Approved	Dec 1, 2021
Increxxa™ RX Tulathromycin Injectable Solution • Subcutaneous, Intramuscular Label highlights Official documents	Elanco US Inc.	ANADA 200-666	Approved	Mar 1, 2021
MACROSYN™ RX Tulathromycin Injectable Solution • Intramuscular, Subcutaneous Label highlights Official documents	Bimeda Animal Health Ltd.	ANADA 200-657	Approved	Mar 1, 2021
Draxxin® 25 Injectable Solution RX Tulathromycin Injectable Solution • Intramuscular, Subcutaneous Label highlights Official documents	Zoetis Inc.	NADA 141-349	Approved	Apr 1, 2019

Data source: FDA Animal Drugs @ FDA (public search export).

What It's For (FDA Label Highlights)

Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.

Species: Dairy calves • Suckling calves • Veal calves

Composition / specifications

25 mg of tulathromycin/mL

Swine

Indication

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (1 mL/22 lb) body weight (BW). Do not inject more than 4 mL per injection site.

Limitations

Suckling Calves, Dairy Calves, and Veal Calves

Indication

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1 mL/22 lb) body weight (BW). Do not inject more than 11.5 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Suckling Calves • Beef • Dairy

Composition / specifications

Each milliliter of solution contains 100 milligrams (mg) tulathromycin.

Swine

Indication

Dosage

Administer 2.5 mg per kilogram (0.25 mL/22 lb) body weight as a single intramuscular injection in the neck.

Limitations

Do not inject more than 2.5 mL per injection site. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Cattle (Beef and Non-Lactating Dairy)

Indication

For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

Dosage

Administer 2.5 mg per kilogram (1.1 mL/100 lb) body weight as a single subcutaneous injection in the neck.

Limitations

Do not use in female dairy cattle 20 months of age or older. Do not inject more than 10 mL per injection site. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Indication

For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.

Dosage

Administer 2.5 mg per kilogram (1.1 mL/100 lb) body weight as a single subcutaneous injection in the neck.

Limitations

Do not use in female dairy cattle 20 months of age or older. Do not inject more than 10 mL per injection site. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Indication

Dosage

Administer 2.5 mg per kilogram (1.1 mL/100 lb) body weight as a single subcutaneous injection in the neck.

Limitations

Do not use in female dairy cattle 20 months of age or older. Do not inject more than 10 mL per injection site. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Cattle (Suckling Calves, Dairy Calves, and Veal Calves)

Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

Dosage

Administer 2.5 mg per kilogram (1.1 mL/100 lb) body weight as a single subcutaneous injection in the neck.

Limitations

Do not inject more than 10 mL per injection site. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Suckling Calves • Beef And Non-Lactating Dairy

Composition / specifications

100 mg of tulathromycin/mL

Beef cattle, non-lactating dairy cattle, suckling calves, dairy calves and veal calves

Indication

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Limitations

Swine

Indication

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (0.25 mL/22 lb) BW. Do not inject more than 2.5 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Suckling Calves

Composition / specifications

25 mg of tulathromycin/mL

Swine

Indication

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (1 mL/22lb) body weight (BW). Do not inject more than 4 mL per injection site.

Limitations

Suckling Calves, Dairy Calves, and Veal Calves

Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1 mL/22lb) BW. Do not inject more than 11.5 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Suckling Calves • Beef And Non-Lactating Dairy

Composition / specifications

100 mg of tulathromycin/mL

Beef and Non-Lactating Dairy Cattle

Indication

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Limitations

Suckling Calves, Dairy Calves, and Veal Calves

Indication

For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Limitations

Swine

Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (0.25 mL/22 lb) BW. Do not inject more than 2.5 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Suckling Calves

Composition / specifications

25 mg of tulathromycin/mL

Swine

Indication

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (1 mL/22 lb) body weight (BW). Do not inject more than 4 mL per injection site.

Limitations

Suckling Calves, Dairy Calves, and Veal Calves

Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dose of 2.5 mg/kg (1 mL/22 lb BW. Do not inject more than 11.5 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Beef And Non-Lactating Dairy • Dairy calves • Suckling calves • Veal calves

Composition / specifications

100 mg of tulathromycin/mL

Beef and non-lactating dairy cattle

Indication

IBK – For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.

Foot Rot – For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Limitations

Suckling calves, dairy calves, and veal calves

Indication

For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Limitations

Swine

Indication

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (0.25 mL/22 lb) BW. Do not inject more than 2.5 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Suckling Calves • Beef And Non-Lactating Dairy

Composition / specifications

100 mg of tulathromycin/mL

Beef and Non-Lactating Dairy Cattle

Indication

For the treatment of infectious bovine keratoconjunctivitis associated with Moraxella bovis.

For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Limitations

Suckling Calves, Dairy Calves, and Veal Calves

Indication

For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Limitations

Swine

Indication

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (0.25 mL/22 lb) BW. Do not inject more than 2.5 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Suckling Calves • Beef And Non-Lactating Dairy

Composition / specifications

100 mg of tulathromycin/mL

Beef and Non-Lactating Dairy Cattle

Indication

For the treatment of infectious bovine keratoconjunctivitis associated with Moraxella bovis.

For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Limitations

Suckling Calves, Dairy Calves, and Veal Calves

Indication

For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Limitations

Swine

Indication

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (0.25 mL/22 lb) BW. Do not inject more than 2.5 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Suckling Calves

Composition / specifications

25 mg tulathromycin/mL

Swine

Indication

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (1mL/22 lb) body weight (BW). Do not inject more than 4 mL per injection site.

Limitations

Suckling Calves, Dairy Calves, and Veal Calves

Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1mL/22 lb) BW. Do not inject more than 11.5 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Suckling Calves • Beef And Non-Lactating Dairy • Dairy calves

Composition / specifications

100 mg of tulathromycin/mL

Beef and Non-Lactating Dairy Cattle

Indication

IBK: For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.

Foot Rot: For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Limitations

Suckling Calves, Dairy Calves, and Veal Calves

Indication

For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Limitations

Swine

Indication

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (0.25 mL/22 lb) BW. Do not inject more than 2.5 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Suckling Calves

Composition / specifications

25 mg/mL of tulathromycin

Swine

Indication

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg(1 mL/22 lb) body weight (BW). Do not inject more than 4 mL per injection site.

Limitations

Suckling Calves, Dairy Calves, and Veal Calves

Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1 mL/22 lb) BW. Do not inject more than 11.5 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Suckling Calves • Beef And Non-Lactating Dairy

Composition / specifications

100 mg of tulathromycin/mL

Beef and Non-Lactating Dairy Cattle

Indication

IBK: For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.

Foot Rot: For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Limitations

Suckling Calves, Dairy Calves, and Veal Calves

Indication

For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Limitations

Swine

Indication

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (0.25 mL/22 lb) BW. Do not inject more than 2.5 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Suckling Calves

Composition / specifications

25 mg tulathromycin/mL

Swine

Indication

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (1 mL/22 lb) body weight (BW). Do not inject more than 4 mL per injection site.

Limitations

Suckling calves, dairy calves, and veal calves

Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1 mL/22 lb) BW. Do not inject more than 11.5 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Suckling Calves • Beef And Non-Lactating Dairy

Composition / specifications

100 mg of tulathromycin/mL

Beef and Non-Lactating Dairy Cattle

Indication

For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.

For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Limitations

Suckling Calves, Dairy Calves, and Veal Calves

Indication

For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Limitations

Swine

Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (0.25 mL/22 lb) BW. Do not inject more than 2.5 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Suckling Calves • Beef And Non-Lactating Dairy

Composition / specifications

100 mg of tulathromycin/mL

Beef and Non-Lactating Dairy Cattle

Indication

For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.

For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb.) bodyweight (BW). Do not inject more than 10 mL per injection site.

Limitations

Suckling Calves, Dairy Calves, and Veal Calves

Indication

For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb.) bodyweight (BW). Do not inject more than 10 mL per injection site.

Limitations

Swine

Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (0.25 mL/22 lb.) BW. Do not inject more than 2.5 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Suckling Calves

Composition / specifications

25 mg/mL

Swine

Indication

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/ kg (1 mL/22 lb) Body Weight (BW).

Limitations

Cattle (Calves)

Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1 mL/22 lb) body weight (BW).

Limitations

FDA page: Open in Animal Drugs @ FDA

Usage

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae , Pasteurella multocida , Bordetella bronchiseptica , Haemophilus parasuis , and Mycoplasma hyopneumoniae ; and for the control of SRD associated with Actinobacillus pleuropneumoniae , Pasteurella multocida , and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed. For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica , Pasteurella multocida , Histophilus somni , and Mycoplasma bovis . For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica , Pasteurella multocida , Histophilus somni , and Mycoplasma bovis , and control of pyrexia associated with BRD in beef steers, beef heifers, beef calves 2 months of age and older, beef bulls, dairy bulls, and replacement dairy heifers.

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Top Reported Reactions (openFDA)

De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).

Digestive

Vomiting (1) • Dog

Showing top 5 for Digestive.

Neurologic

Tiredness (1) • Dog Seizure NOS (1) • Dog Neurological signs NOS (1) • Cat Tiredness (lethargy) • Dog

Showing top 5 for Neurologic.

Effectiveness

Lack of efficacy - NOS (1) • Dog Lack of efficacy (bacteria) - NOS (1) • Dog

Showing top 5 for Effectiveness.

Other

Vocalisation (1) • Cat Trouble breathing (1) • Dog Pneumothorax (1) • Dog Panting (1) • Dog Overdose (1) • Dog

Show more (15)

Oral cavity disorder NOS (1) • Dog Non-regenerative anaemia (1) • Dog Medication error NOS (1) • Cat Intentional misuse (1) • Dog Injection site reaction NOS (1) • Dog Head bobbing (1) • Cat General illness (1) • Cat Elevated blood urea nitrogen (1) • Cat Elevated aspartate aminotransferase (1) • Cat Elevated alanine aminotransferase (1) • Cat Decreased packed cell volume (1) • Dog Cutaneous emphysema (1) • Dog Coughing up blood (1) • Dog Blindness (1) • Cat Agglutination test, positive (1) • Dog

Showing top 5 for Other.

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Adverse Event Case Summaries (openFDA)

These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.

Cat, Domestic Shorthair, Male, 2 year, 5.08 kilogram • Drug: MSK, Injection, Unknown • Reactions: General illness, Medication error NOS • Outcome: Outcome Unknown

Report ID: USA-USFDACVM-2026-US-013230
Serious AE: No
Treated For AE: No
Sex: Male
Age: 2.00 Year
Weight: 5.080 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Unknown
Form: Injection

Reactions Reported:

General illness Medication error NOS

Outcomes: Outcome Unknown

Dog, ['Schnauzer (unspecified)', 'Dog (unknown)'], Female, 2 year • Drug: MSK, Injection, Unknown • Reactions: Non-regenerative anaemia, Medication error NOS • Outcome: Ongoing

Report ID: USA-USFDACVM-2026-US-006495
Serious AE: No
Treated For AE: Yes
Sex: Female
Age: 2.00 Year

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Unknown
Form: Injection

Reactions Reported:

Non-regenerative anaemia Medication error NOS

Outcomes: Ongoing

Dog, Schnauzer - Miniature, Female, 7.58 year, 6.305 kilogram • Drug: MSK, Injection, Intramuscular, Dose: 0.20 mL per animal • Reactions: Seizure NOS, Decreased packed cell volume, Intentional misuse, Vomiting, Agglutination test, positive • Outcome: Ongoing

Report ID: USA-USFDACVM-2026-US-004960
Serious AE: Yes
Treated For AE: Yes
Sex: Female
Age: 7.58 Year
Weight: 6.305 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Intramuscular
Form: Injection
Dose: 0.20 mL per animal

Reactions Reported:

Seizure NOS Decreased packed cell volume Intentional misuse Vomiting Agglutination test, positive

Outcomes: Ongoing

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Overdose Information

No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.

Storage & Handling

No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.

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Medical Disclaimer: The medication details provided on Roxee are for informational purposes only and are not a substitute for professional veterinary advice. Always consult your veterinarian about your pet's specific needs.

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