USA-USFDACVM-2026-US-008467
Received 2026-02-26 · MSK · MSK
- Species
- Dog
- Breed
- Dachshund (unspecified)
- Size / weight
- 10-24 lb (6.8 Kilogram)
- Age
- 4-7 years (6 Year)
- Sex
- Female Neutered
- Region
- USA
- Reactions
- Blindness
- Body systems
- Other
- Outcomes
- Ongoing
Roxee Medication Guide
Ceftiofur
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
FDA data linked
Rx required
Liquid (Solution)
Multiple FDA sponsors
Official label facts
Owner quick guide first
Veterinary professional?
Showing simplified owner view. Switch to Vet View for full technical detail.
Data freshness
Reference facts
Reference refreshed
Aug 6, 2026, 7:47 p.m.
These are the reference facts Roxee uses on browse cards and quick facts.
FDA applications
FDA application data refreshed
Aug 6, 2026, 7:47 p.m.
Sponsor, product, and application records imported from Animal Drugs @ FDA.
Safety reports
Safety data refreshed
Aug 6, 2026, 7:49 p.m.
openFDA reaction terms and case summaries are supporting evidence, not proof of causality.
Source timing details
Source timing details
-
Reference facts:
Source Roxee
| Refreshed Aug 6, 2026, 7:47 PM UTC
The reference fact projection used for browse cards and quick facts.
-
Animal Drugs @ FDA:
Source FDA
| Refreshed Aug 6, 2026, 7:47 PM 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.
- openFDA reaction terms: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
- openFDA case summaries: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
Illustration placeholder
Ceftiofur
Ceftiofur
Drug type: Generic ingredient • Generic profile • No FDA branded products linked
Both
Liquid (Solution)
Rx required
100% reference complete
Species: Both
Manufacturer: Multiple FDA sponsors
Medication Snapshot
Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.
Ceftiofur
For treatment of respiratory infections in horses associated with Streptococcus zooepidemicus . Treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, P. multocida, and Histophilus somni in beef and dairy cattle For treatment of acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus . Species commonly shown: Both, Dog, Horse, Not For Meat Production.
Generic name
Ceftiofur
Brand names
Naxcel® Sterile Powder, Excenel® Sterile Powder Excenel® RTU Excenel Sterile Suspension, Spectramast® LC Sterile Suspension, Spectramast™ DC Sterile Suspension
Manufacturer
Multiple FDA sponsors
Species
Both, Dog, Horse, Goat
Dosage forms
Liquid (Solution), Liquid (Suspension), Powder-Sterile, Sterile suspension
Prescription
Prescription required
Completeness
100%
Validation
Complete
Brand names
Naxcel® Sterile Powder
Excenel® Sterile Powder Excenel® RTU Excenel Sterile Suspension
Spectramast® LC Sterile Suspension
Spectramast™ DC Sterile Suspension
EXCENEL® RTU EZ
Ceftiofur for Injection
Cefenil® RTU
Dosage forms
Liquid (Solution)
Liquid (Suspension)
Powder-Sterile
Sterile suspension
Indications / Uses
For treatment of respiratory infections in horses associated with Streptococcus zooepidemicus . Treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica , P. multocida , and Histophilus somni in beef and dairy cattle For treatment of acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus .
Warnings / Contraindications
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Treated swine must not be slaughtered for 4 days following the last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Treated cattle must not be slaughtered for 3 days following the last treatment. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
- Federal law restricts this drug to use by or on the order of a licensed veterinarian. Treated swine must not be slaughtered for 4 days following the last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Treated cattle must not be slaughtered for 3 days following the last treatment. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Side Effects
Top reported reactions (openFDA): Abnormal cytology, Abnormal histology NOS, Corneal ulcer, Death by euthanasia, Decreased appetite, Dermal plaque.
FAQ
Both, Dog, Horse, Not For Meat Production, Goat, Beef, Dairy, Day old poults, 1 day-old broiler chicks, Sheep, Cattle, Excluding Veal Calves, Dairy, lactating, Dairy, dry cows, Beef And Non-Lactating Dairy, Swine, Cattle, Turkey, Poults, Day Old, Day-Old Chicks
Yes. Roxee shows this as prescription-only.
Liquid (Solution), Liquid (Suspension), Powder-Sterile, Sterile suspension
Related Conditions
Source Transparency
- Verified source: https://www.roxee.ai/meds/
- Verified source: https://animaldrugsatfda.fda.gov
- 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/733
- Verified source: https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/732
- Last refreshed: Aug 6, 2026, 7:47 p.m.
- Last verified: Apr 22, 2026, 10:07 a.m.
- Validation status: Complete
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Sign in to continuePet Owner Quick Guide
Start here first for the safest next-step summary before the deeper medication detail.
Used for:
For treatment of respiratory infections in horses associated with Streptococcus zooepidemicus .
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:
- Treated swine must not be slaughtered for 4 days following the last treatment
- Treated cattle must not be slaughtered for 3 days following the last treatment
- A withdrawal period has not been established in preruminating calves
- Do not use in calves to be processed for veal
- Do not use in horses intended for human consumption
- Tendon injury (1 reports)
- Swelling NOS (1 reports)
- Surgical site disorder (1 reports)
When to call the vet:
- Repeated vomiting or diarrhea.
- Severe lethargy (hard to wake, very low energy).
- Collapse or fainting.
- Trouble breathing.
- Facial swelling or hives.
- Blood in vomit or stool.
Regulatory restrictions are shown in Vet View.
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?
Research brief
Medication Research Insights
A source-aware map of what to know, what is uncertain, and what to verify with your veterinarian.
What to know
Evidence-backed context
Limited
Roxee has limited cited overview evidence for Ceftiofur; use the official documents and your veterinarian's instructions for product-specific decisions.
Source: openFDA case USA-USFDACVM-2022-US-041779
Safety signal coverage
Reported signals
32 tracked reaction signals; 32 reported cases; 32 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.
Source: openFDA case USA-USFDACVM-2022-US-041779
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-2022-US-041779
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
Tendon injury (1 reports), Swelling NOS (1 reports), Surgical site disorder (1 reports), Regurgitation (1 reports), Panniculitis (1 reports)
Body systems represented
Signal grouping
Digestive (1), Skin & allergy (3), Effectiveness (1), Other (27)
Species and breed lens
Species represented in reports
Species lens
Dog (24 reports), Cat (8 reports)
Breed metadata in reports
Metadata only
Dachshund (unspecified) (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 Ceftiofur 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
Treated swine must not be slaughtered for 4 days following the last treatment, Treated cattle must not be slaughtered for 3 days following the last treatment, A withdrawal period has not been established in preruminating calves, Do not use in calves to be processed for veal, Do not use in horses intended for human consumption
Call sooner if
Escalation
Repeated vomiting or diarrhea. Severe lethargy (hard to wake, very low energy). Collapse or fainting.
Bottom line: Use this Ceftiofur 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-2022-US-041779 · 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
- FOI · document · documents
- FOI · document · documents
Evidence
Review status / Updated / Sources
Review status: Clinical reviewer not listed
Updated: April 22, 2026, 10:07 AM UTC
Sources:
- FDA application profile · official_label
- FDA application profile · official_label
- Medication usage source · fda_animal_drugs
- Cefenil® RTU · official_label
- openFDA case USA-USFDACVM-2022-US-041779 · adverse_reaction
Safety & side effects
Side effects to monitor:
- Treated swine must not be slaughtered for 4 days following the last treatment
- Treated cattle must not be slaughtered for 3 days following the last treatment
- A withdrawal period has not been established in preruminating calves
- Do not use in calves to be processed for veal
- Do not use in horses intended for human consumption
Most reported reactions:
- Tendon injury (1 reports)
- Swelling NOS (1 reports)
- Surgical site disorder (1 reports)
Emergency warning signs:
- Repeated vomiting or diarrhea.
- Severe lethargy (hard to wake, very low energy).
- Collapse or fainting.
- Trouble breathing.
Vet Fast Scan
Source-backed clinical checkpoints for quick review.
FDA-labeled species
1 day-old broiler chicks, Beef, Beef And Non-Lactating Dairy, Cattle, Dairy, Day old poults, Day-Old Chicks, Dog, Goat, Horse, Sheep, Swine, Turkey
Indication / use
For treatment of respiratory infections in horses associated with Streptococcus zooepidemicus .
Form / route / dose
Form: Liquid (Solution), Liquid (Suspension), Powder-Sterile, Sterile suspension
Route: Injection, Intramammary, Intramuscular, Subcutaneous
Confirm product label and patient-specific plan.
Route: Injection, Intramammary, Intramuscular, Subcutaneous
Confirm product label and patient-specific plan.
Warnings
- High: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Treated swine must not be slaught…
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.
Quick Facts
Official label facts first, then secondary summaries. Marketing content is separated below.
Species: Both
Manufacturer: Multiple FDA sponsors
Form: Liquid (Solution), Liquid (Suspension), Powder-Sterile, Sterile suspension
Identifiers:
ANADA: 200421
ANADA: 200616
NADA: 140338
NADA: 140890
NADA: 141209
NADA: 141235
NADA: 141238
NADA: 141239
NADA: 141288
NDC Package: 49553-1261-1
NDC Package: 49553-1261-2
NDC Package: 54771-3362-1
NDC Package: 54771-3362-2
NDC Package: 54771-5223-1
NDC Package: 54771-5224-1
NDC Package: 54771-5224-2
NDC Package: 54771-5224-3
NDC Package: 54771-5224-4
NDC Package: 54771-5278-1
NDC Package: 54771-5278-2
Source metadata:
- https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/140338 · official_label · FDA application profile
- https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/141288 · official_label · FDA application profile
- https://animaldrugsatfda.fda.gov · fda_animal_drugs · Medication usage source
Warnings / Contraindications
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Treated swine must not be slaughtered for 4 days following the last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Treated cattle must not be slaughtered for 3 days following the last treatment. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
- High: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Treated swine must not be slaughtered for 4 days following the last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Treated cattle must not be slaughtered for 3 days following the last treatment. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in horses intended for human consumption. Federal law restricts this drug to use by 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.
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
1
Matching reports
1
Active filters
0
Drill into common report signals
Showing up to 50 matching reports.
Tap or hover a reaction to see what it means in plain language.
Tracked signals
32
Reported cases
32
Serious reports
32
Species represented
2
Grouped by Body System
Digestive (1)
· Decreased appetite
Skin & allergy (3)
· Swelling NOS, Injection site swelling, Erythematous rash
Effectiveness (1)
· Lack of efficacy - NOS
Other (27)
· Tendon injury, Surgical site disorder, Regurgitation
Most Reported Reactions
| Reaction | Body system | Cases | Species | Serious cases |
|---|---|---|---|---|
| Other | 1 | Dog | 1 | |
| Skin & allergy | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 |
Species coverage: Dog (24) Cat (8)
View detailed reaction table
| Reaction | Body system | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|---|
| Other | Dog | Serious | - | 1 | |
| Skin & allergy | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Effectiveness | Cat | Serious | - | 1 | |
| Skin & allergy | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Skin & allergy | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Digestive | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 |
Source metadata:
- https://api.fda.gov/animalandveterinary/event.json · adverse_reaction · openFDA case USA-USFDACVM-2022-US-041779
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.
140-338
Official label / PI · EA
140-338
Official label / PI · FONSI
140-338
Official label / PI · EA
Full source previews and metadata remain in the veterinary/professional layer.
Owner handouts
0No owner handouts linked yet.
Official label / PI
8SPL
9FOI
37140-338
Official label / PI · EA
140-338
Official label / PI · FONSI
140-338
Official label / PI · EA
140-338
Official label / PI · FONSI
140-890
Official label / PI · EA
140-890
Official label / PI · FONSI
140-890
Official label / PI · EA
140-890
Official label / PI · FONSI
Naxcel® Sterile Powder
SPL · SPL
FDA Structured Product Label
Naxcel® Sterile Powder
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
- 140-338
- Status
- RX
- Form
- Liquid (Solution)
- Route
- Intramuscular, Subcutaneous
- Species
- Dog • Horse • Goat • Beef • Dairy • Day old poults • 1 day-old broiler chicks • Sheep
Composition / specifications
Each milliliter of aqueous solution constituted from ceftiofur sodium powder contains 50 milligrams (mg) ceftiofur equivalents.
Horses
Indication
For treatment of respiratory infections in horses associated with Streptococcus zooepidemicus.
Dosage
2.2 to 4.4 mg/kg (1.0 to 2.0 mg/lb) body weight by intramuscular injection. Treatment should be repeated every 24 hours, continued for 48 hours after clinical signs have disappeared, and should not exceed 10 days. A maximum of 10 mL should be administered per injection site.
Cattle
Indication
Treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, P. multocida, and Histophilus somni in beef and dairy cattle
Dosage
0.5 to 1.0 mg/lb body weight by intramuscular or subcutaneous injection for 3 days. Additional treatments may be given on days 4 and 5 for animals which do not show satisfactory response.
Indication
For treatment of acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus.
Dosage
0.5 to 1.0 mg/lb body weight by intramuscular or subcutaneous injection for 3 days. Additional treatments may be given on days 4 and 5 for animals which do not show satisfactory response.
Swine
Indication
For treatment and control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus (Haemophilus) pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis, and Streptococcus suis.
Dosage
3 to 5 mg per kilogram (/kg) body weight by intramuscular injection for 3 consecutive days.
Sheep
Indication
For treatment of sheep respiratory disease (pneumonia) associated with M. haemolytica and P. multocida.
Dosage
0.5 to 1.0 mg/lb body weight by intramuscular injection for 3 days. Additional treatments may be given on days 4 and 5 for animals which do not show satisfactory response.
Chickens (Day Old Chicks)
Indication
For control of early mortality associated with Escherichia coli organisms susceptible to ceftiofur in day-old chicks.
Dosage
0.08 to 0.20 mg as a single subcutaneous injection in the neck.
Turkeys (Day Old Poults)
Indication
For control of early mortality associated with E. coli organisms susceptible to ceftiofur in day-old poults.
Dosage
0.17 to 0.5 mg as a single subcutaneous injection in the neck.
Dogs
Indication
Treatment of canine urinary tract infections associated with E. coli and Proteus mirabilis.
Dosage
1.0 mg/lb (2.2 mg/kg) body weight by subcutaneous injection. Treatment should be repeated at 24-hour intervals, continued for 48 hours after clinical signs have disappeared, for 5 to 14 days.
Goats
Indication
For treatment of caprine respiratory disease (goat pneumonia) associated with M. haemolytica and P. multocida.
Dosage
0.5 to 1.0 mg/lb body weight by intramuscular injection for 3 days. Additional treatments may be given on days 4 and 5 for animals which do not show satisfactory response.
EXCENEL® RTU EZ
SPL · SPL
FDA Structured Product Label
EXCENEL® RTU EZ
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
- 141-288
- Status
- RX
- Form
- Liquid (Suspension)
- Route
- Intramuscular, Subcutaneous
- Species
- Beef And Non-Lactating Dairy • Dairy
Composition / specifications
Each mL contains 50 mg of ceftiofur equivalents (CE).
Cattle (Beef, Non-Lactating Dairy, Lactating Dairy)
Indication
For treatment of Acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus.
Dosage
Administer by intramuscular or subcutaneous administration 0.5 to 1 mg CE/lb (1.1 to 2.2 mg CE/kg) BW (1 to 2 mL sterile suspension per 100 lb BW). Administer daily at 24-hour intervals for a total of three consecutive days. Additional treatments may be administered on Days 4 and 5 for animals which do not show a satisfactory response (not recovered) after the initial three treatments.
Indication
For treatment of Acute metritis (0 to 14 days post-partum) associated with bacterial organisms susceptible to ceftiofur.
Dosage
Administer by intramuscular or subcutaneous administration at the dosage of 1 mg CE/lb (2.2 mg CE/kg) BW (2 mL sterile suspension per 100 lb BW). Administer at 24 hour intervals for five consecutive days. Do not inject more than 15 mL per injection site.
Indication
For treatment of Bovine respiratory disease (BRD, shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Dosage
Administer by intramuscular or subcutaneous administration at the dosage of 0.5 to 1 mg CE/lb (1.1 to 2.2 mg CE/kg) BW (1 to 2 mL sterile suspension per 100 lb BW). Administer daily at 24 hour intervals for a total of three consecutive days. Additional treatments may be administered on Days 4 and 5 for animals which do not show a satisfactory response (not recovered) after the initial three treatments. Alternatively, for BRD only, administer intramuscularly or subcutaneously 1 mg CE/ lb (2.2 mg CE/kg) BW every other day on Days 1 and 3 (48 hour interval). Selection of dosage level (0.5 to 1 mg CE/lb) and regimen/duration (daily or every other day for BRD only) should be based on an assessment of the severity of disease, pathogen susceptibility and clinical response. Do not inject more than 15 mL per injection site.
Swine
Indication
For treatment/control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella Choleraesuis and Streptococcus suis.
Dosage
Administer intramuscularly at a dosage of 1.36 to 2.27 mg ceftiofur equivalents (CE)/lb (3 to 5 mg CE/kg) body weight (BW) (1 mL of sterile suspension per 22 to 37 lb BW). Treatment should be repeated at 24 hour intervals for a total of three consecutive days. Do not inject more than 15 mL per injection site.
Cefenil® RTU
SPL · SPL
FDA Structured Product Label
Cefenil® RTU
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
- 200-616
- Status
- RX
- Form
- Sterile suspension
- Route
- Injection
Composition / specifications
50 mg/mL
Swine
Indication
For treatment/control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus (Haemophilus) pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis and Streptococcus suis.
Dosage
Administer intramuscularly at a dosage of 1.36 to 2.27 mg ceftiofur equivalents/lb (3.0 to 5.0 mg/kg) BW (1 mL of sterile suspension per 22 to 37 lb BW). Treatment should be repeated at 24 h intervals for a total of three consecutive days.
Cattle
Indication
For treatment of the following bacterial diseases:
- Bovine respiratory disease (BRD, shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
- Acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus.
- Acute metritis (0 to 14 days post-partum) associated with bacterial organisms susceptible to ceftiofur.
Dosage
For bovine respiratory disease and acute bovine interdigital necrobacillosis: administer by intramuscular or subcutaneous administration at the dosage of 0.5 to 1.0 mg ceftiofur equivalents/lb (1.1 to 2.2 mg/kg) BW (1 to 2 mL sterile suspension per 100 lb BW). Administer daily at 24 h intervals for a total of three consecutive days. Additional treatments may be administered on Days 4 and 5 for animals which do not show a satisfactory response (not recovered) after the initial three treatments. In addition, for BRD only, administer intramuscularly or subcutaneously 1.0 mg ceftiofur equivalents/lb (2.2 mg/kg) BW every other day on Days 1 and 3 (48 h interval). Do not inject more than 15 mL per injection site. Selection of dosage level (0.5 to 1.0 mg/lb) and regimen/duration (daily or every other day for BRD only) should be based on an assessment of the severity of disease, pathogen susceptibility and clinical response. For acute post-partum metritis: administer by intramuscular or subcutaneous administration at the dosage of 1.0 mg ceftiofur equivalents/lb (2.2 mg/kg) BW (2 mL sterile suspension per 100 lb BW). Administer at 24 h intervals for five consecutive days. Do not inject more than 15 mL per injection site.
Ceftiofur for Injection
SPL · SPL
FDA Structured Product Label
Ceftiofur for 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
- Hospira, Inc.
- ANADA
- 200-421
- Status
- RX
- Form
- Powder-Sterile
- Route
- Subcutaneous, Intramuscular
- Species
- Dog • Goat • Swine • Cattle • Turkey • Day-Old Chicks • Sheep
<strong>Cattle</strong>
Indication
For treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni. Also, for treatment of acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus.
Dosage
0.5 to 1.0 mg per pound (1.1 to 2.2 mg/kg) of body weight (1-2 mL reconstituted sterile solution per 100 lbs body weight). Treatment should be repeated at 24-hour intervals for a total of 3 consecutive days. Additional treatments may be given on days four and five for animals which do not show a satisfactory response (not recovered) after the initial three treatments
<strong>Swine</strong>
Indication
For treatment/control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus (Haemophilus) pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis, and Streptococcus suis.
Dosage
1.36 to 2.27 mg per pound (3.0 to 5.0 mg/kg) of body weight (1 mL of reconstituted sterile solution per 22 to 37 lbs body weight). Treatment should be repeated at 24-hour intervals for a total of 3 consecutive days.
<strong>Sheep</strong>
Indication
For treatment of sheep respiratory disease (sheep pneumonia) associated with Mannheimia haemolytica and Pasteurella multocida.
Dosage
0.5 to 1.0 mg per pound (1.1 to 2.2 mL reconstituted sterile solution per 100 lbs body weight). Treatment should be repeated at 24-hour intervals for a total of 3 consecutive days. Additional treatments may be given on days four and five for animals which do not show a satisfactory response (not recovered) after the initial three treatments.
<strong>Goats</strong>
Indication
For treatment of caprine respiratory disease (goat pneumonia) associated with Mannheimia haemolytica and Pasteurella multocida.
Dosage
0.5 to 1.0 mg per pound (1.1 to 2.2 mg/kg) of body weight (1-2 mL reconstituted sterile solution per 100 lbs body weight). Treatment should be repeated at 24-hour intervals for a total of 3 consecutive days. Additional treatments may be given on days four and five for animals which do not show a satisfactory response (not recovered) after the initial three treatments.
<strong>Horses</strong>
Indication
For treatment of respiratory infections in horses associated with
Streptococcus zooepidemicus.
Dosage
1.0 to 2.0 mg per pound (2.2 to 4.4 mg/kg) of body weight (2-4 mL reconstituted sterile solution per 100 lb body weight). A maximum of 10 mL may be administered per injection site. Treatment should be repeated at 24-hour intervals,
continued for 48 hours after clinical signs have disappeared and should not exceed 10 days.
<strong>Dogs</strong>
Indication
For the treatment of canine urinary tract infections associated with Escherichia coli and Proteus mirabilis.
Dosage
1.0 mg per pound 2.2 mg/kg) of body weight (0.1 mL reconstituted sterile solution per 5 lbs body weight). Treatment should be repeated at 24 hour intervals for 5-14 days.
<strong>Day-Old Chicks</strong>
Indication
For the control of early mortality, associated with E. coli organisms susceptible to ceftiofur, in day-old chicks.
Dosage
0.08 to 0.20 mg/chick. One mL of the 50 mg/mL reconstituted solution will treat approximately 250 to 625 day-old chicks.
<strong>Day-Old Turkey Poults</strong>
Indication
For the control of early mortality, associated with E. coli organisms susceptible to ceftiofur, in day-old turkey poults.
Dosage
0.17 to 0.5 mg/poult. 1 ml of the 50 mg/mL reconstituted solution will treat approximately 100 to 294 day-old turkey poults.
Excenel® Sterile Powder
SPL · SPL
FDA Structured Product Label
Excenel® Sterile Powder Excenel® RTU Excenel Sterile Suspension
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
- 140-890
- Status
- RX
- Form
- Liquid (Suspension)
- Route
- Subcutaneous, Intramuscular
- Species
- Cattle
Composition / specifications
Each milliliter of ceftiofur hydrochloride suspension contains 50 milligrams (mg) of ceftiofur equivalents.
Swine
Indication
For treatment and control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis, and Streptococcus suis.
Dosage
3 to 5 milligrams per kilogram of body weight by intramuscular injection. Treatment should be repeated at 24-hour intervals for a total of 3 consecutive days.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Treated swine must not be slaughtered for 4 days following the last treatment.
Cattle (excluding veal calves)
Indication
For treatment of bovine respiratory disease (BRD, shipping fever, pneumonia) associated with Mannheimia haemolytica, P. multocida, and Histophilus somni; acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus; and acute metritis (0 to 14 days post-partum) associated with bacteria susceptible to ceftiofur.
Dosage
1.1 to 2.2 mg/kg of body weight by intramuscular or subcutaneous injection, at 24-hour intervals for 3 to 5 consecutive days. For bovine respiratory disease, 2.2 mg/kg of body weight may be administered twice at a 48-hour interval. For acute metritis, administer 2.2 mg/kg of body weight daily for 5 consecutive days.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Treated cattle must not be slaughtered for 3
days following the last treatment. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Excenel® RTU
SPL · SPL
FDA Structured Product Label
Excenel® Sterile Powder Excenel® RTU Excenel Sterile Suspension
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
- 140-890
- Status
- RX
- Form
- Liquid (Suspension)
- Route
- Subcutaneous, Intramuscular
- Species
- Cattle
Composition / specifications
Each milliliter of ceftiofur hydrochloride suspension contains 50 milligrams (mg) of ceftiofur equivalents.
Swine
Indication
For treatment and control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis, and Streptococcus suis.
Dosage
3 to 5 milligrams per kilogram of body weight by intramuscular injection. Treatment should be repeated at 24-hour intervals for a total of 3 consecutive days.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Treated swine must not be slaughtered for 4 days following the last treatment.
Cattle (excluding veal calves)
Indication
For treatment of bovine respiratory disease (BRD, shipping fever, pneumonia) associated with Mannheimia haemolytica, P. multocida, and Histophilus somni; acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus; and acute metritis (0 to 14 days post-partum) associated with bacteria susceptible to ceftiofur.
Dosage
1.1 to 2.2 mg/kg of body weight by intramuscular or subcutaneous injection, at 24-hour intervals for 3 to 5 consecutive days. For bovine respiratory disease, 2.2 mg/kg of body weight may be administered twice at a 48-hour interval. For acute metritis, administer 2.2 mg/kg of body weight daily for 5 consecutive days.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Treated cattle must not be slaughtered for 3
days following the last treatment. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Excenel Sterile Suspension
SPL · SPL
FDA Structured Product Label
Excenel® Sterile Powder Excenel® RTU Excenel Sterile Suspension
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
- 140-890
- Status
- RX
- Form
- Liquid (Suspension)
- Route
- Subcutaneous, Intramuscular
- Species
- Cattle
Composition / specifications
Each milliliter of ceftiofur hydrochloride suspension contains 50 milligrams (mg) of ceftiofur equivalents.
Swine
Indication
For treatment and control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis, and Streptococcus suis.
Dosage
3 to 5 milligrams per kilogram of body weight by intramuscular injection. Treatment should be repeated at 24-hour intervals for a total of 3 consecutive days.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Treated swine must not be slaughtered for 4 days following the last treatment.
Cattle (excluding veal calves)
Indication
For treatment of bovine respiratory disease (BRD, shipping fever, pneumonia) associated with Mannheimia haemolytica, P. multocida, and Histophilus somni; acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus; and acute metritis (0 to 14 days post-partum) associated with bacteria susceptible to ceftiofur.
Dosage
1.1 to 2.2 mg/kg of body weight by intramuscular or subcutaneous injection, at 24-hour intervals for 3 to 5 consecutive days. For bovine respiratory disease, 2.2 mg/kg of body weight may be administered twice at a 48-hour interval. For acute metritis, administer 2.2 mg/kg of body weight daily for 5 consecutive days.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Treated cattle must not be slaughtered for 3
days following the last treatment. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Spectramast™ DC Sterile Suspension
SPL · SPL
FDA Structured Product Label
Spectramast™ DC Sterile Suspension
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
- 141-239
- Status
- RX
- Form
- Liquid (Suspension)
- Route
- Intramammary
- Species
- Dairy
Composition / specifications
Each single-use, 10-milliliter syringe of ceftiofur hydrochloride suspension contains or 500 milligrams (mg)ceftiofur equivalents.
Dairy cattle (At Dry Off)
Indication
For the treatment of subclinical mastitis in dairy cattle at the time of dry off associated with Staphylococcus aureus, Streptococcus dysgalactiae, and Streptococcus uberis.
Dosage
Infuse 500 mg per affected quarter at the time of dry off.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Spectramast® LC Sterile Suspension
SPL · SPL
FDA Structured Product Label
Spectramast® LC Sterile Suspension
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
- 141-238
- Status
- RX
- Form
- Liquid (Suspension)
- Route
- Intramammary
- Species
- Dairy
Composition / specifications
Each single-use, 10-milliliter syringe of ceftiofur hydrochloride suspension contains 125 milligrams (mg) ceftiofur equivalents.
Lactating Dairy Cattle
Indication
For use in lactating dairy cattle for (1) the treatment of clinical mastitis associated with coagulase-negative staphylococci, Streptococcus dysgalactiae, and Escherichia coli and (2) the treatment of diagnosed subclinical mastitis associated with coagulase-negative staphylococci and Streptococcus dysgalactiae.
Dosage
Infuse 125 mg per affected quarter. Repeat treatment in 24 hours. Once daily treatment may be repeated for up to 8 consecutive days.
Limitations
Milk taken from cows during treatment (a maximum of eight daily infusions) and for 72 hours after the last treatment must not be used for human consumption. Following label use for up to eight consecutive days, a 2-day pre-slaughter withdrawal period is required. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal Law prohibits extra-label use of this drug in lactating dairy cattle for disease prevention purposes; at unapproved doses; frequencies, durations, or routes of administration; and in unapproved major food producing species/production classes.
ucm049847.pdf
FOI · FOI
ucm049846.pdf
FOI · FOI
ucm049844.pdf
FOI · FOI
ucm049843.pdf
FOI · FOI
ucm049842.pdf
FOI · FOI
ucm049841.pdf
FOI · FOI
N140338_Supp_10_25_96.pdf
FOI · FOI
UCM470933.pdf
FOI · FOI
N140338_Supp_08-24-1995.pdf
FOI · FOI
UCM539438.pdf
FOI · FOI
N140338_Supp_08_04_1992.pdf
FOI · FOI
N140338_Supp_03-15-1991.pdf
FOI · FOI
UCM490826.pdf
FOI · FOI
UCM478009.pdf
FOI · FOI
FOI Summary sN 141-288 Approved May 6, 2019.pdf
FOI · FOI
UCM377873.pdf
FOI · FOI
UCM208544.pdf
FOI · FOI
FOI Summary oA 200-616 Approved January 28, 2019.pdf
FOI · FOI
UCM307677.pdf
FOI · FOI
ucm059129.pdf
FOI · FOI
ucm059128.pdf
FOI · FOI
ucm059127.pdf
FOI · FOI
ucm059124.pdf
FOI · FOI
ucm059122.pdf
FOI · FOI
ucm059120.pdf
FOI · FOI
ucm118055.pdf
FOI · FOI
ucm118053.pdf
FOI · FOI
UCM446090.pdf
FOI · FOI
ucm118052.pdf
FOI · FOI
ucm118051.pdf
FOI · FOI
ucm118047.pdf
FOI · FOI summary
UCM235349.pdf
FOI · FOI summary
ucm117761.pdf
FOI · FOI summary
ucm117768.pdf
FOI · FOI summary
ucm117772.pdf
FOI · FOI summary
UCM203951.pdf
FOI · FOI summary
UCM307680.pdf
FOI · FOI summary
Source metadata:
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/477 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/476 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/475 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/474 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/473 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/472 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/3693 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/471 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1717 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/470 · document · FOI
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 Aug 6, 2026, 7:47 PM UTC
The reference fact projection used for browse cards and quick facts.
-
Animal Drugs @ FDA:
Source FDA
| Refreshed Aug 6, 2026, 7:47 PM 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.
- openFDA reaction terms: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
- openFDA case summaries: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
Official (FDA)
Identity: Generic ingredient
• No FDA branded products linked
No official FDA brand rows linked yet for this ingredient.
Case-reported brands (openFDA):
MSK
Catalog species: Both
•
FDA-labeled species: 1 day-old broiler chicks, Beef, Beef And Non-Lactating Dairy, Cattle, Dairy, Day old poults, Day-Old Chicks, Dog, Goat, Horse, Sheep, Swine, Turkey
Rx/OTC: RX
Form/route:
Liquid (Solution), Liquid (Suspension), Powder-Sterile, Sterile suspension
• Injection, Intramammary, Intramuscular, Subcutaneous
Applications: NADA 140-338 • NADA 141-288 • ANADA 200-616 • ANADA 200-421 • NADA 140-890 • NADA 141-239 • NADA 141-238
Explore
Related conditions:
Mastitis
Metritis
Pneumonia (aspiration, bacterial, viral)
Pododermatitis
Urinary tract infection (cystitis)
Linked using:
Fda_Label (0.95),
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
- Federal law restricts this drug to use by or on the order of a licensed veterinarian. Treated swine must not be slaughtered for 4 days following the last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Treated cattle must not be slaughtered for 3 days following the last treatment. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (Contraindication, High)
Top reaction signals
Tendon injury (1)
Swelling NOS (1)
Surgical site disorder (1)
Regurgitation (1)
Panniculitis (1)
Neutrophilia (1)
Lymphadenopathy (1)
Localised oedema (1)
Identifiers & Packages
Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.
Identifiers
ANADA: 200421
ANADA: 200616
NADA: 140338
NADA: 140890
NADA: 141209
NADA: 141235
NADA: 141238
NADA: 141239
NADA: 141288
NDC Package: 49553-1261-1
NDC Package: 49553-1261-2
NDC Package: 54771-3362-1
NDC Package: 54771-3362-2
NDC Package: 54771-5223-1
NDC Package: 54771-5224-1
NDC Package: 54771-5224-2
NDC Package: 54771-5224-3
NDC Package: 54771-5224-4
NDC Package: 54771-5278-1
NDC Package: 54771-5278-2
NDC Package: 54771-5279-1
NDC Package: 54771-5279-2
NDC Package: 54771-5402-1
NDC Package: 54771-5402-2
| Package NDC | Product NDC | Form / Route | Status |
|---|---|---|---|
| 49553-1261-1 | 49553 | - | |
| 49553-1261-2 | 49553 | - | |
| 54771-3362-1 | 54771 | - | |
| 54771-3362-2 | 54771 | - | |
| 54771-5223-1 | 54771 | - | |
| 54771-5224-1 | 54771 | - | |
| 54771-5224-2 | 54771 | - | |
| 54771-5224-3 | 54771 | - | |
| 54771-5224-4 | 54771 | - | |
| 54771-5278-1 | 54771 | - | |
| 54771-5278-2 | 54771 | - | |
| 54771-5279-1 | 54771 | - | |
| 54771-5279-2 | 54771 | - | |
| 54771-5402-1 | 54771 | - | |
| 54771-5402-2 | 54771 | - | |
| 55529-163-02 | 55529 | - | |
| 55529-163-04 | 55529 | - | |
| 58597-8170-9 | 58597 | - | |
| 58597-8171-8 | 58597 | - | |
| 58597-8171-9 | 58597 | - |
Enriched Documents
Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.
-
ucm118047.pdf
• FOI summary • Official
• Feb. 28, 2024
FDA FOI summary for application 141235
-
UCM235349.pdf
• FOI summary • Official
• Feb. 28, 2024
FDA FOI summary for application 141235
-
ucm117761.pdf
• FOI summary • Official
• Feb. 28, 2024
FDA FOI summary for application 141209
-
ucm117768.pdf
• FOI summary • Official
• Feb. 28, 2024
FDA FOI summary for application 141209
-
ucm117772.pdf
• FOI summary • Official
• Feb. 28, 2024
FDA FOI summary for application 141209
-
UCM203951.pdf
• FOI summary • Official
• Feb. 28, 2024
FDA FOI summary for application 141209
-
UCM307680.pdf
• FOI summary • Official
• Feb. 28, 2024
FDA FOI summary for application 141209
-
UCM478009.pdf
• FOI summary • Official
• Sept. 6, 2022
FDA FOI summary for application 140338
-
UCM490826.pdf
• FOI summary • Official
• Sept. 6, 2022
FDA FOI summary for application 140338
-
N140338_Supp_03-15-1991.pdf
• FOI summary • Official
• Sept. 6, 2022
FDA FOI summary for application 140338
-
N140338_Supp_08_04_1992.pdf
• FOI summary • Official
• Sept. 6, 2022
FDA FOI summary for application 140338
-
UCM539438.pdf
• FOI summary • Official
• Sept. 6, 2022
FDA FOI summary for application 140338
-
N140338_Supp_08-24-1995.pdf
• FOI summary • Official
• Sept. 6, 2022
FDA FOI summary for application 140338
-
UCM470933.pdf
• FOI summary • Official
• Sept. 6, 2022
FDA FOI summary for application 140338
-
N140338_Supp_10_25_96.pdf
• FOI summary • Official
• Sept. 6, 2022
FDA FOI summary for application 140338
-
ucm049841.pdf
• FOI summary • Official
• Sept. 6, 2022
FDA FOI summary for application 140338
-
ucm049842.pdf
• FOI summary • Official
• Sept. 6, 2022
FDA FOI summary for application 140338
-
ucm049843.pdf
• FOI summary • Official
• Sept. 6, 2022
FDA FOI summary for application 140338
-
ucm049844.pdf
• FOI summary • Official
• Sept. 6, 2022
FDA FOI summary for application 140338
-
ucm049846.pdf
• FOI summary • Official
• Sept. 6, 2022
FDA FOI summary for application 140338
-
ucm049847.pdf
• FOI summary • Official
• Sept. 6, 2022
FDA FOI summary for application 140338
-
UCM208544.pdf
• FOI summary • Official
• June 3, 2019
FDA FOI summary for application 141288
-
UCM377873.pdf
• FOI summary • Official
• June 3, 2019
FDA FOI summary for application 141288
-
FOI Summary sN 141-288 Approved May 6, 2019.pdf
• FOI summary • Official
• June 3, 2019
FDA FOI summary for application 141288
-
FOI Summary oA 200-616 Approved January 28, 2019.pdf
• FOI summary • Official
• Jan. 31, 2019
FDA FOI summary for application 200616
-
UCM307677.pdf
• FOI summary • Official
• Jan. 16, 2018
FDA FOI summary for application 200421
-
ucm059120.pdf
• FOI summary • Official
• Dec. 18, 2017
FDA FOI summary for application 140890
-
ucm059122.pdf
• FOI summary • Official
• Dec. 18, 2017
FDA FOI summary for application 140890
-
ucm059124.pdf
• FOI summary • Official
• Dec. 18, 2017
FDA FOI summary for application 140890
-
ucm059127.pdf
• FOI summary • Official
• Dec. 18, 2017
FDA FOI summary for application 140890
-
ucm059128.pdf
• FOI summary • Official
• Dec. 18, 2017
FDA FOI summary for application 140890
-
ucm059129.pdf
• FOI summary • Official
• Dec. 18, 2017
FDA FOI summary for application 140890
-
ucm118053.pdf
• FOI summary • Official
• June 1, 2016
FDA FOI summary for application 141239
-
ucm118055.pdf
• FOI summary • Official
• June 1, 2016
FDA FOI summary for application 141239
-
ucm118051.pdf
• FOI summary • Official
• June 1, 2016
FDA FOI summary for application 141238
-
ucm118052.pdf
• FOI summary • Official
• June 1, 2016
FDA FOI summary for application 141238
-
UCM446090.pdf
• FOI summary • Official
• June 1, 2016
FDA FOI summary for application 141238
Data Sources & Change Log
Every non-trivial field is expected to include provenance and update timestamps.
Official 149
Clinical 7
Manufacturer 0
Marketing 0
Current Field Facts
- contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Treated swine must not be slaughtered for 4 days following the last treat… (Clinical, 2026-04-15)
- contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Treated swine must not be slaughtered for 4 days following the last treat… (Clinical, 2026-04-11)
- side_effects: Top reported reactions (openFDA): Abnormal cytology, Abnormal histology NOS, Corneal ulcer, Death by euthanasia, Decreased appetite, Dermal plaque. (Clinical, 2026-04-22)
- side_effects: Top reported reactions (openFDA): Abnormal cytology, Abnormal histology NOS, Corneal ulcer, Death by euthanasia, Decreased appetite, Dermal plaque. (Clinical, 2026-04-15)
- side_effects: Top reported reactions (openFDA): Abnormal cytology, Abnormal histology NOS, Corneal ulcer, Death by euthanasia, Decreased appetite, Dermal plaque. (Clinical, 2026-04-11)
- usage: For treatment of respiratory infections in horses associated with Streptococcus zooepidemicus . Treatment of bovine respiratory disease (shipping fever, pneumo… (Clinical, 2026-04-15)
- usage: For treatment of respiratory infections in horses associated with Streptococcus zooepidemicus . Treatment of bovine respiratory disease (shipping fever, pneumo… (Clinical, 2026-04-11)
- contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Treated swine must not be slaughtered for 4 days following the last treat… (Official, 2026-07-03)
- contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Treated swine must not be slaughtered for 4 days following the last treat… (Official, 2026-04-22)
- contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Treated swine must not be slaughtered for 4 days following the last treat… (Official, 2026-02-12)
- indications: Cattle: For treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus s… (Official, 2026-08-06)
- indications: Cattle: For treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus s… (Official, 2026-08-05)
- indications: Cattle: For treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus s… (Official, 2026-08-04)
- indications: Cattle: For treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus s… (Official, 2026-08-03)
- indications: Cattle: For treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus s… (Official, 2026-08-02)
- indications: Cattle: For treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus s… (Official, 2026-08-01)
- indications: Cattle: For treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus s… (Official, 2026-07-31)
- indications: Cattle: For treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus s… (Official, 2026-07-30)
- indications: Cattle: For treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus s… (Official, 2026-07-29)
- indications: Cattle: For treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus s… (Official, 2026-07-28)
Recent Revisions
- side_effects updated 2026-07-03 11:05 by etl_backfill • Backfilled from existing medication fields
- contraindications updated 2026-07-03 11:05 by etl_backfill • Backfilled from existing medication fields
- usage updated 2026-07-03 11:05 by etl_backfill • Backfilled from existing medication fields
- side_effects updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
- contraindications updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
- usage updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
- side_effects updated 2026-04-15 10:04 by etl_backfill • Backfilled from existing medication fields
- contraindications updated 2026-04-15 10:04 by etl_backfill • Backfilled from existing medication fields
- usage updated 2026-04-15 10:04 by etl_backfill • Backfilled from existing medication fields
- side_effects updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
- contraindications updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
- usage updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
- side_effects updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
- contraindications updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
- usage updated 2026-02-12 22:44 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 |
|---|---|---|---|---|
|
Naxcel® Sterile Powder
RX
Ceftiofur Sodium
Liquid (Solution)
• Intramuscular, Subcutaneous
|
Zoetis Inc. | NADA 140-338 | Approved | Sep 6, 2022 |
|
EXCENEL® RTU EZ
RX
Ceftiofur Hydrochloride
Liquid (Suspension)
• Intramuscular, Subcutaneous
|
Zoetis Inc. | NADA 141-288 | Approved | Jun 3, 2019 |
|
Cefenil® RTU
RX
Ceftiofur Hydrochloride
Sterile suspension
• Injection
|
Norbrook Laboratories, Ltd. | ANADA 200-616 | Approved | Jan 31, 2019 |
|
Ceftiofur for Injection
RX
Ceftiofur Sodium
Powder-Sterile
• Subcutaneous, Intramuscular
|
Hospira, Inc. | ANADA 200-421 | W | Jan 16, 2018 |
|
Excenel® Sterile Powder Excenel® RTU Excenel Sterile Suspension
RX
Ceftiofur Hydrochloride
Liquid (Suspension)
• Subcutaneous, Intramuscular
|
Zoetis Inc. | NADA 140-890 | Approved | Dec 18, 2017 |
|
Spectramast™ DC Sterile Suspension
RX
Ceftiofur Hydrochloride
Liquid (Suspension)
• Intramammary
|
Zoetis Inc. | NADA 141-239 | Approved | Jun 1, 2016 |
|
Spectramast® LC Sterile Suspension
RX
Ceftiofur Hydrochloride
Liquid (Suspension)
• Intramammary
|
Zoetis Inc. | NADA 141-238 | Approved | Jun 1, 2016 |
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: Dog • Horse • Goat • Beef • Dairy • Day old poults • 1 day-old broiler chicks • Sheep
Composition / specifications
Each milliliter of aqueous solution constituted from ceftiofur sodium powder contains 50 milligrams (mg) ceftiofur equivalents.
Horses
Indication
For treatment of respiratory infections in horses associated with Streptococcus zooepidemicus.
Dosage
2.2 to 4.4 mg/kg (1.0 to 2.0 mg/lb) body weight by intramuscular injection. Treatment should be repeated every 24 hours, continued for 48 hours after clinical signs have disappeared, and should not exceed 10 days. A maximum of 10 mL should be administered per injection site.
Limitations
Cattle
Indication
Treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, P. multocida, and Histophilus somni in beef and dairy cattle
Dosage
0.5 to 1.0 mg/lb body weight by intramuscular or subcutaneous injection for 3 days. Additional treatments may be given on days 4 and 5 for animals which do not show satisfactory response.
Limitations
Indication
For treatment of acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus.
Dosage
0.5 to 1.0 mg/lb body weight by intramuscular or subcutaneous injection for 3 days. Additional treatments may be given on days 4 and 5 for animals which do not show satisfactory response.
Limitations
Swine
Indication
For treatment and control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus (Haemophilus) pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis, and Streptococcus suis.
Dosage
3 to 5 mg per kilogram (/kg) body weight by intramuscular injection for 3 consecutive days.
Limitations
Sheep
Indication
For treatment of sheep respiratory disease (pneumonia) associated with M. haemolytica and P. multocida.
Dosage
0.5 to 1.0 mg/lb body weight by intramuscular injection for 3 days. Additional treatments may be given on days 4 and 5 for animals which do not show satisfactory response.
Limitations
Chickens (Day Old Chicks)
Indication
For control of early mortality associated with Escherichia coli organisms susceptible to ceftiofur in day-old chicks.
Dosage
0.08 to 0.20 mg as a single subcutaneous injection in the neck.
Limitations
Turkeys (Day Old Poults)
Indication
For control of early mortality associated with E. coli organisms susceptible to ceftiofur in day-old poults.
Dosage
0.17 to 0.5 mg as a single subcutaneous injection in the neck.
Limitations
Dogs
Indication
Treatment of canine urinary tract infections associated with E. coli and Proteus mirabilis.
Dosage
1.0 mg/lb (2.2 mg/kg) body weight by subcutaneous injection. Treatment should be repeated at 24-hour intervals, continued for 48 hours after clinical signs have disappeared, for 5 to 14 days.
Limitations
Goats
Indication
For treatment of caprine respiratory disease (goat pneumonia) associated with M. haemolytica and P. multocida.
Dosage
0.5 to 1.0 mg/lb body weight by intramuscular injection for 3 days. Additional treatments may be given on days 4 and 5 for animals which do not show satisfactory response.
Limitations
FDA page: Open in Animal Drugs @ FDA
Species: Beef And Non-Lactating Dairy • Dairy
Composition / specifications
Each mL contains 50 mg of ceftiofur equivalents (CE).
Cattle (Beef, Non-Lactating Dairy, Lactating Dairy)
Indication
For treatment of Acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus.
Dosage
Administer by intramuscular or subcutaneous administration 0.5 to 1 mg CE/lb (1.1 to 2.2 mg CE/kg) BW (1 to 2 mL sterile suspension per 100 lb BW). Administer daily at 24-hour intervals for a total of three consecutive days. Additional treatments may be administered on Days 4 and 5 for animals which do not show a satisfactory response (not recovered) after the initial three treatments.
Limitations
Indication
For treatment of Acute metritis (0 to 14 days post-partum) associated with bacterial organisms susceptible to ceftiofur.
Dosage
Administer by intramuscular or subcutaneous administration at the dosage of 1 mg CE/lb (2.2 mg CE/kg) BW (2 mL sterile suspension per 100 lb BW). Administer at 24 hour intervals for five consecutive days. Do not inject more than 15 mL per injection site.
Limitations
Indication
For treatment of Bovine respiratory disease (BRD, shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Dosage
Administer by intramuscular or subcutaneous administration at the dosage of 0.5 to 1 mg CE/lb (1.1 to 2.2 mg CE/kg) BW (1 to 2 mL sterile suspension per 100 lb BW). Administer daily at 24 hour intervals for a total of three consecutive days. Additional treatments may be administered on Days 4 and 5 for animals which do not show a satisfactory response (not recovered) after the initial three treatments. Alternatively, for BRD only, administer intramuscularly or subcutaneously 1 mg CE/ lb (2.2 mg CE/kg) BW every other day on Days 1 and 3 (48 hour interval). Selection of dosage level (0.5 to 1 mg CE/lb) and regimen/duration (daily or every other day for BRD only) should be based on an assessment of the severity of disease, pathogen susceptibility and clinical response. Do not inject more than 15 mL per injection site.
Limitations
Swine
Indication
For treatment/control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella Choleraesuis and Streptococcus suis.
Dosage
Administer intramuscularly at a dosage of 1.36 to 2.27 mg ceftiofur equivalents (CE)/lb (3 to 5 mg CE/kg) body weight (BW) (1 mL of sterile suspension per 22 to 37 lb BW). Treatment should be repeated at 24 hour intervals for a total of three consecutive days. Do not inject more than 15 mL per injection site.
Limitations
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
50 mg/mL
Swine
Indication
For treatment/control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus (Haemophilus) pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis and Streptococcus suis.
Dosage
Administer intramuscularly at a dosage of 1.36 to 2.27 mg ceftiofur equivalents/lb (3.0 to 5.0 mg/kg) BW (1 mL of sterile suspension per 22 to 37 lb BW). Treatment should be repeated at 24 h intervals for a total of three consecutive days.
Limitations
Cattle
Indication
For treatment of the following bacterial diseases:
- Bovine respiratory disease (BRD, shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
- Acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus.
- Acute metritis (0 to 14 days post-partum) associated with bacterial organisms susceptible to ceftiofur.
Dosage
For bovine respiratory disease and acute bovine interdigital necrobacillosis: administer by intramuscular or subcutaneous administration at the dosage of 0.5 to 1.0 mg ceftiofur equivalents/lb (1.1 to 2.2 mg/kg) BW (1 to 2 mL sterile suspension per 100 lb BW). Administer daily at 24 h intervals for a total of three consecutive days. Additional treatments may be administered on Days 4 and 5 for animals which do not show a satisfactory response (not recovered) after the initial three treatments. In addition, for BRD only, administer intramuscularly or subcutaneously 1.0 mg ceftiofur equivalents/lb (2.2 mg/kg) BW every other day on Days 1 and 3 (48 h interval). Do not inject more than 15 mL per injection site. Selection of dosage level (0.5 to 1.0 mg/lb) and regimen/duration (daily or every other day for BRD only) should be based on an assessment of the severity of disease, pathogen susceptibility and clinical response. For acute post-partum metritis: administer by intramuscular or subcutaneous administration at the dosage of 1.0 mg ceftiofur equivalents/lb (2.2 mg/kg) BW (2 mL sterile suspension per 100 lb BW). Administer at 24 h intervals for five consecutive days. Do not inject more than 15 mL per injection site.
Limitations
FDA page: Open in Animal Drugs @ FDA
Species: Dog • Goat • Swine • Cattle • Turkey • Day-Old Chicks • Sheep
<strong>Cattle</strong>
Indication
For treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni. Also, for treatment of acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus.
Dosage
0.5 to 1.0 mg per pound (1.1 to 2.2 mg/kg) of body weight (1-2 mL reconstituted sterile solution per 100 lbs body weight). Treatment should be repeated at 24-hour intervals for a total of 3 consecutive days. Additional treatments may be given on days four and five for animals which do not show a satisfactory response (not recovered) after the initial three treatments
Limitations
<strong>Swine</strong>
Indication
For treatment/control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus (Haemophilus) pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis, and Streptococcus suis.
Dosage
1.36 to 2.27 mg per pound (3.0 to 5.0 mg/kg) of body weight (1 mL of reconstituted sterile solution per 22 to 37 lbs body weight). Treatment should be repeated at 24-hour intervals for a total of 3 consecutive days.
Limitations
<strong>Sheep</strong>
Indication
For treatment of sheep respiratory disease (sheep pneumonia) associated with Mannheimia haemolytica and Pasteurella multocida.
Dosage
0.5 to 1.0 mg per pound (1.1 to 2.2 mL reconstituted sterile solution per 100 lbs body weight). Treatment should be repeated at 24-hour intervals for a total of 3 consecutive days. Additional treatments may be given on days four and five for animals which do not show a satisfactory response (not recovered) after the initial three treatments.
Limitations
<strong>Goats</strong>
Indication
For treatment of caprine respiratory disease (goat pneumonia) associated with Mannheimia haemolytica and Pasteurella multocida.
Dosage
0.5 to 1.0 mg per pound (1.1 to 2.2 mg/kg) of body weight (1-2 mL reconstituted sterile solution per 100 lbs body weight). Treatment should be repeated at 24-hour intervals for a total of 3 consecutive days. Additional treatments may be given on days four and five for animals which do not show a satisfactory response (not recovered) after the initial three treatments.
Limitations
<strong>Horses</strong>
Indication
For treatment of respiratory infections in horses associated with
Streptococcus zooepidemicus.
Dosage
1.0 to 2.0 mg per pound (2.2 to 4.4 mg/kg) of body weight (2-4 mL reconstituted sterile solution per 100 lb body weight). A maximum of 10 mL may be administered per injection site. Treatment should be repeated at 24-hour intervals,
continued for 48 hours after clinical signs have disappeared and should not exceed 10 days.
Limitations
<strong>Dogs</strong>
Indication
For the treatment of canine urinary tract infections associated with Escherichia coli and Proteus mirabilis.
Dosage
1.0 mg per pound 2.2 mg/kg) of body weight (0.1 mL reconstituted sterile solution per 5 lbs body weight). Treatment should be repeated at 24 hour intervals for 5-14 days.
Limitations
<strong>Day-Old Chicks</strong>
Indication
For the control of early mortality, associated with E. coli organisms susceptible to ceftiofur, in day-old chicks.
Dosage
0.08 to 0.20 mg/chick. One mL of the 50 mg/mL reconstituted solution will treat approximately 250 to 625 day-old chicks.
Limitations
<strong>Day-Old Turkey Poults</strong>
Indication
For the control of early mortality, associated with E. coli organisms susceptible to ceftiofur, in day-old turkey poults.
Dosage
0.17 to 0.5 mg/poult. 1 ml of the 50 mg/mL reconstituted solution will treat approximately 100 to 294 day-old turkey poults.
Limitations
FDA page: Open in Animal Drugs @ FDA
Species: Cattle
Composition / specifications
Each milliliter of ceftiofur hydrochloride suspension contains 50 milligrams (mg) of ceftiofur equivalents.
Swine
Indication
For treatment and control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis, and Streptococcus suis.
Dosage
3 to 5 milligrams per kilogram of body weight by intramuscular injection. Treatment should be repeated at 24-hour intervals for a total of 3 consecutive days.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Treated swine must not be slaughtered for 4 days following the last treatment.
Cattle (excluding veal calves)
Indication
For treatment of bovine respiratory disease (BRD, shipping fever, pneumonia) associated with Mannheimia haemolytica, P. multocida, and Histophilus somni; acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus; and acute metritis (0 to 14 days post-partum) associated with bacteria susceptible to ceftiofur.
Dosage
1.1 to 2.2 mg/kg of body weight by intramuscular or subcutaneous injection, at 24-hour intervals for 3 to 5 consecutive days. For bovine respiratory disease, 2.2 mg/kg of body weight may be administered twice at a 48-hour interval. For acute metritis, administer 2.2 mg/kg of body weight daily for 5 consecutive days.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Treated cattle must not be slaughtered for 3
days following the last treatment. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
FDA page: Open in Animal Drugs @ FDA
Species: Dairy
Composition / specifications
Each single-use, 10-milliliter syringe of ceftiofur hydrochloride suspension contains or 500 milligrams (mg)ceftiofur equivalents.
Dairy cattle (At Dry Off)
Indication
For the treatment of subclinical mastitis in dairy cattle at the time of dry off associated with Staphylococcus aureus, Streptococcus dysgalactiae, and Streptococcus uberis.
Dosage
Infuse 500 mg per affected quarter at the time of dry off.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
FDA page: Open in Animal Drugs @ FDA
Species: Dairy
Composition / specifications
Each single-use, 10-milliliter syringe of ceftiofur hydrochloride suspension contains 125 milligrams (mg) ceftiofur equivalents.
Lactating Dairy Cattle
Indication
For use in lactating dairy cattle for (1) the treatment of clinical mastitis associated with coagulase-negative staphylococci, Streptococcus dysgalactiae, and Escherichia coli and (2) the treatment of diagnosed subclinical mastitis associated with coagulase-negative staphylococci and Streptococcus dysgalactiae.
Dosage
Infuse 125 mg per affected quarter. Repeat treatment in 24 hours. Once daily treatment may be repeated for up to 8 consecutive days.
Limitations
Milk taken from cows during treatment (a maximum of eight daily infusions) and for 72 hours after the last treatment must not be used for human consumption. Following label use for up to eight consecutive days, a 2-day pre-slaughter withdrawal period is required. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal Law prohibits extra-label use of this drug in lactating dairy cattle for disease prevention purposes; at unapproved doses; frequencies, durations, or routes of administration; and in unapproved major food producing species/production classes.
FDA page: Open in Animal Drugs @ FDA
Usage
For treatment of respiratory infections in horses associated with Streptococcus zooepidemicus . Treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica , P. multocida , and Histophilus somni in beef and dairy cattle For treatment of acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus .
Source: FDA Animal Drugs @ FDA • Reference
Contraindications
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Treated swine must not be slaughtered for 4 days following the last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Treated cattle must not be slaughtered for 3 days following the last treatment. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Top Reported Reactions (openFDA)
De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).
Digestive
Decreased appetite (1)
• Dog
Showing top 5 for Digestive.
Skin & allergy
Swelling NOS (1)
• Dog
Injection site swelling (1)
• Dog
Erythematous rash (1)
• Dog
Showing top 5 for Skin & allergy.
Effectiveness
Lack of efficacy - NOS (1)
• Cat
Showing top 5 for Effectiveness.
Other
Tendon injury (1)
• Dog
Surgical site disorder (1)
• Dog
Regurgitation (1)
• Dog
Panniculitis (1)
• Dog
Neutrophilia (1)
• Cat
Show more (22)
Lymphadenopathy (1)
• Dog
Localised oedema (1)
• Dog
Injection site skin discolouration (1)
• Dog
Injection site serosanguinous discharge (1)
• Dog
Injection site self trauma (1)
• Dog
Injection site oedema (1)
• Dog
Injection site necrosis (1)
• Dog
Injection site infection (1)
• Dog
Injection site bruising (1)
• Dog
Injection site bleeding (1)
• Dog
Hypophosphataemia (1)
• Cat
Hyperglycaemia (1)
• Cat
Elevated serum alkaline phosphatase (1)
• Cat
Elevated alanine aminotransferase (1)
• Cat
Diabetes (1)
• Cat
Dermatitis (1)
• Dog
Dermal plaque (1)
• Dog
Death by euthanasia (1)
• Dog
Corneal ulcer (1)
• Cat
Blindness (1)
• Dog
Abnormal histology NOS (1)
• Dog
Abnormal cytology (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.
Dog, Dachshund (unspecified), Female, 6 year, 6.8 kilogram • Drug: MSK, Parenteral • Reactions: Blindness • Outcome: Ongoing
- Report ID: USA-USFDACVM-2026-US-008467
- Serious AE: Yes
- Treated For AE: No
- Sex: Female
- Age: 6.00 Year
- Weight: 6.800 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Parenteral
Reactions Reported:
Blindness
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.