Roxee Meds Catalog

Tulathromycin

Medication catalog facts with explicit FDA-approval, off-label, source-limited, and safety context.

Both Catalog complete Livestock/food-animal use Rx required Injectable 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

Storefront facts

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FDA applications

FDA application data refreshed

May 5, 2026, 10:00 a.m.

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

Safety reports

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

Source timing details

Storefront facts: Source Roxee | Refreshed May 5, 2026, 10:05 AM UTC
The storefront fact projection used for browse cards and quick facts.
Animal Drugs @ FDA: Source FDA | Refreshed May 5, 2026, 10:00 AM UTC
Applications/products are imported from FDA export data.
Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
Label highlights/doc links are fetched from FDA preview endpoints.
Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed May 5, 2026, 10:00 AM UTC
Package/product NDCs from FDA’s electronic listing directory (XLS).

Evidence

Reviewed / Updated / Sources

Reviewed by: Not available

Last reviewed: February 12, 2026

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
Tulaject™ 100 · official_label
openFDA case USA-USFDACVM-2024-US-013392 · adverse_reaction

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Tulathromycin

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

Both Injectable Solution Rx required 100% storefront ready

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, No use class stated or implied, Suckling Calves, Dairy Calves, Veal Calves.

Generic name

Tulathromycin

Brand names

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

Manufacturer

Multiple FDA labelers

Species

Both, No use class stated or implied, Suckling Calves, Dairy Calves, Veal Calves, Beef And Non-Lactating Dairy

Dosage forms

Injectable Solution

Prescription

Prescription required

Completeness

100%

Validation

Complete

Brand names

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™ Arovyn Increxxa VACASAN RESPIRmycin Tulieve RESPIRmycin 25 Draxxin Tulissin 100 VACASAN 25 Increxxa 25 Tulissin 25 TULATHROMYCIN Macrosyn Draxxin 25

Dosage forms

Injectable Solution

Indications / Uses

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, No use class stated or implied, Suckling Calves, Dairy Calves, Veal Calves, Beef And Non-Lactating Dairy, Dairy calves, Suckling calves, Veal calves

Yes. Roxee shows this as prescription-only.

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/10884
Last refreshed: May 5, 2026, 10:05 a.m.
Last verified: Feb 12, 2026, 10:44 p.m.
Validation status: Complete

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Pet Owner Quick Guide

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Used for:

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 con...

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
Vocalisation (1 reports)
trouble breathing (1 reports)
very low energy (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?

Major cautions & emergency warning signs

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:

Vocalisation (1 reports)
Trouble breathing (dyspnea) (1 reports)
Tiredness (lethargy) (1 reports)

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

Quick Facts

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

Species: Both

Manufacturer: Multiple FDA labelers

Form: Injectable 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 NADA: 141349 NADA: 141543 NDC Package: 0061-6607-02 NDC Package: 0061-6607-03 NDC Package: 0061-6607-04 NDC Package: 0061-6607-05

Source metadata:

https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/200742 · official_label · FDA application profile
https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/200774 · 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.

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

Neurologic (3) · Tiredness (lethargy), Neurological signs NOS, Lethargy (see also Central nervous system depression in 'Neurological') Effectiveness (2) · Lack of efficacy - NOS, Lack of efficacy (bacteria) - NOS Other (17) · Vocalisation, Trouble breathing (dyspnea), Pneumothorax

Most Reported Reactions

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

Species coverage: Dog (12) Cat (10)

View detailed reaction table

Body system	Species	Seriousness	Frequency	Reports
Other	Cat	Serious	-	1
Other	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
Neurologic	Cat	Serious	-	1
Effectiveness	Dog	Non-serious	-	1
Effectiveness	Dog	Non-serious	-	1
Other	Dog	Serious	-	1
Other	Cat	Serious	-	1
Other	Cat	Serious	-	1
Other	Cat	Serious	-	1
Other	Cat	Serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Serious	-	1
Other	Cat	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-2024-US-013392

Documents

Owner handouts and official technical documents open on-page first, with the original source still one click away.

Owner handouts

No owner handouts linked yet.

Official label / PI

No official label or package insert links yet.

SPL

FOI

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, Dairy Calves, Veal 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, Dairy Calves, Veal 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, Dairy Calves, Veal 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: No use class stated or implied • Suckling Calves, Dairy Calves, Veal 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: No use class stated or implied • Suckling Calves, Dairy Calves, Veal 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: No use class stated or implied • Suckling Calves, Dairy Calves, Veal 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: No use class stated or implied • Suckling Calves, Dairy Calves, Veal 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: No use class stated or implied • Suckling Calves, Dairy Calves, Veal 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 Limited
ANADA: 200-657
Status: RX
Form: Injectable Solution
Route: Intramuscular, Subcutaneous
Species: No use class stated or implied • Suckling Calves, Dairy Calves, Veal 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: No use class stated or implied • Suckling Calves, Dairy Calves, Veal 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/16586 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/16868/Tulathromycin%20Injection · document · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/15846 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/16167/Tulaject%E2%84%A2 · document · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/15825 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/16145/Tulaject%E2%84%A2%20100 · document · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/13658 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/13855/RESPIRmycin%E2%84%A2%2025 · document · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/13114 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/13217/RESPIRmycin%E2%84%A2 · 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

Storefront facts: Source Roxee | Refreshed May 5, 2026, 10:05 AM UTC
The storefront fact projection used for browse cards and quick facts.
Animal Drugs @ FDA: Source FDA | Refreshed May 5, 2026, 10:00 AM UTC
Applications/products are imported from FDA export data.
Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
Label highlights/doc links are fetched from FDA preview endpoints.
Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed May 5, 2026, 10:00 AM UTC
Package/product NDCs from FDA’s electronic listing directory (XLS).

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

Catalog species: Both • FDA-labeled species: Beef And Non-Lactating Dairy, Dairy calves, No use class stated or implied, Suckling Calves, Suckling calves, Veal calves

Rx/OTC: RX

Form/route: Injectable Solution • Intramuscular, Subcutaneous

Applications: 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: 16 (FOI: 16) • SPL: 15 • Label highlights • Official documents

Safety (openFDA)

Top reactions: Dog 0 • Cat 0 • View

Case summaries: 0

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

Vocalisation (1) Trouble breathing (dyspnea) (1) Tiredness (lethargy) (1) Pneumothorax (1) Panting (1) Neurological signs NOS (1) Injection site reaction NOS (1) Head bobbing (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 200-742 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 79 Clinical 9 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, 2026-05-05)
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, 2026-05-03)
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, 2026-04-30)
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, 2026-04-29)
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, 2026-04-28)
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, 2026-04-27)
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, 2026-04-26)
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, 2026-04-25)
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, 2026-04-11)
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 us… (Official, 2026-05-05)
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 us… (Official, 2026-05-03)
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 us… (Official, 2026-04-30)
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 us… (Official, 2026-04-29)
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 us… (Official, 2026-04-28)
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 us… (Official, 2026-04-27)
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 us… (Official, 2026-04-26)
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 us… (Official, 2026-04-25)
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 us… (Official, 2026-04-11)
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 us… (Official, 2026-02-12)
indications: Beef and Non-Lactating Dairy Cattle BRD- For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, H… (Official, 2026-05-05)

Recent Revisions

side_effects updated 2026-05-05 10:05 by etl_backfill • Backfilled from existing medication fields
contraindications updated 2026-05-05 10:05 by etl_backfill • Backfilled from existing medication fields
usage updated 2026-05-05 10:05 by etl_backfill • Backfilled from existing medication fields
side_effects updated 2026-05-03 10:05 by etl_backfill • Backfilled from existing medication fields
contraindications updated 2026-05-03 10:05 by etl_backfill • Backfilled from existing medication fields
usage updated 2026-05-03 10:05 by etl_backfill • Backfilled from existing medication fields
side_effects updated 2026-04-30 10:09 by etl_backfill • Backfilled from existing medication fields
contraindications updated 2026-04-30 10:09 by etl_backfill • Backfilled from existing medication fields
usage updated 2026-04-30 10:09 by etl_backfill • Backfilled from existing medication fields
side_effects updated 2026-04-29 10:05 by etl_backfill • Backfilled from existing medication fields
contraindications updated 2026-04-29 10:05 by etl_backfill • Backfilled from existing medication fields
usage updated 2026-04-29 10:05 by etl_backfill • Backfilled from existing medication fields
side_effects updated 2026-04-28 10:05 by etl_backfill • Backfilled from existing medication fields
contraindications updated 2026-04-28 10:05 by etl_backfill • Backfilled from existing medication fields
usage updated 2026-04-28 10:05 by etl_backfill • Backfilled from existing medication fields
side_effects updated 2026-04-27 10:05 by etl_backfill • Backfilled from existing medication fields
contraindications updated 2026-04-27 10:05 by etl_backfill • Backfilled from existing medication fields
usage updated 2026-04-27 10:05 by etl_backfill • Backfilled from existing medication fields
side_effects updated 2026-04-26 10:06 by etl_backfill • Backfilled from existing medication fields
contraindications updated 2026-04-26 10:06 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
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 Limited	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: Suckling Calves, Dairy Calves, Veal 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, Dairy 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/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, Dairy Calves, Veal 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: No use class stated or implied • Suckling Calves, Dairy 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

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: No use class stated or implied • 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: No use class stated or implied • Suckling Calves, Dairy Calves, Veal 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: No use class stated or implied • Suckling Calves, Dairy Calves, Veal 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: No use class stated or implied • Suckling Calves, Dairy Calves, Veal 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: No use class stated or implied • Suckling Calves, Dairy Calves, Veal 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: No use class stated or implied • Suckling Calves, Dairy Calves, Veal 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: No use class stated or implied • Suckling Calves, Dairy Calves, Veal 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: No use class stated or implied • Suckling Calves, Dairy Calves, Veal 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: No use class stated or implied • Suckling Calves, Dairy Calves, Veal 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: No use class stated or implied • Suckling Calves, Dairy Calves, Veal 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: No use class stated or implied • Suckling Calves, Dairy Calves, Veal 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

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).

Neurologic

Tiredness (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 (9)

Oral cavity disorder NOS (1) • Dog Injection site reaction NOS (1) • Dog Head bobbing (1) • Cat Elevated blood urea nitrogen (1) • Cat Elevated aspartate aminotransferase (1) • Cat Elevated alanine aminotransferase (1) • Cat Cutaneous emphysema (1) • Dog Coughing up blood (1) • Dog Blindness (1) • Cat

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.

No case-level openFDA reports are linked for this medication yet.

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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This medication has not been reviewed by a veterinarian yet.

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.

Tulathromycin

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Tulathromycin

Medication Snapshot

Tulathromycin

Indications / Uses

Warnings / Contraindications

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FAQ

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Does this usually require a prescription?

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Warnings / Contraindications

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Official label / PI

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FOI

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