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Roxee Meds Catalog

Ceftiofur

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

Both Catalog complete FDA data linked Rx required Liquid (Solution) Multiple FDA sponsors Official label facts Owner quick guide first
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Data freshness

Storefront facts
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Apr 22, 2026, 10:07 a.m.

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

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

Safety reports
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Source timing details
Source timing details
  • Storefront facts: Source Roxee | Refreshed Apr 22, 2026, 10:07 AM UTC
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  • Animal Drugs @ FDA: Source FDA | Refreshed May 5, 2026, 10:00 AM UTC
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Evidence

Reviewed / Updated / Sources

Reviewed by: Not available

Last reviewed: April 22, 2026

Updated: April 22, 2026, 10:07 AM UTC

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Ceftiofur

Ceftiofur

Drug type: Generic ingredient • Generic profile • No FDA branded products linked

Both Liquid (Solution) Rx required 100% storefront ready

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, No Use Class Stated Or Implied, Horse, Not For Meat Production.

Generic name
Ceftiofur
Brand names
Naxcel® Sterile Powder, Ceftiofur for Injection, Excenel® Sterile Powder Excenel® RTU Excenel Sterile Suspension, Spectramast® LC Sterile Suspension
Manufacturer
Multiple FDA sponsors
Species
Both, Dog, No Use Class Stated Or Implied, Horse, Not For Meat Production, Goat, No Use Class Stated Or Implied
Dosage forms
Liquid (Solution), Powder-Sterile, Liquid (Suspension), Sterile suspension
Prescription
Prescription required
Completeness
100%
Validation
Complete
Brand names
Naxcel® Sterile Powder Ceftiofur for Injection Excenel® Sterile Powder Excenel® RTU Excenel Sterile Suspension Spectramast® LC Sterile Suspension Spectramast™ DC Sterile Suspension EXCENEL® RTU EZ Cefenil® RTU
Dosage forms
Liquid (Solution) Powder-Sterile Liquid (Suspension) 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, No Use Class Stated Or Implied, Horse, Not For Meat Production, Goat, No Use Class Stated Or Implied, No use class stated or implied, Beef, Dairy, Day old poults, 1 day-old broiler chicks, Sheep, No Use Class Stated Or Implied, Swine, No Use Class Stated Or Implied, Cattle, No Use Class Stated Or Implied, Turkey, Poults, Day Old, Day-Old Chicks, Cattle, Excluding Veal Calves, Dairy, lactating, Dairy, dry cows, Beef And Non-Lactating Dairy

Yes. Roxee shows this as prescription-only.

Liquid (Solution), Powder-Sterile, Liquid (Suspension), Sterile suspension

Related Conditions

Mastitis Metritis Pneumonia (aspiration, bacterial, viral) Pododermatitis Urinary tract infection (cystitis)

Source Transparency

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Pet Owner Quick Guide

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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?
Major cautions & emergency warning signs

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.
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 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:

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:

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
32
Reported cases
31
Serious reports
31
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 (23) Cat (9)

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 Cat Unknown - -
Source metadata:

Documents

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

Owner handouts

0
No owner handouts linked yet.

Official label / PI

8

SPL

9

FOI

37

140-338

Official label / PI · EA

Open original

140-338

Official label / PI · FONSI

Open original

140-338

Official label / PI · EA

Open original

140-338

Official label / PI · FONSI

Open original

140-890

Official label / PI · EA

Open original

140-890

Official label / PI · FONSI

Open original

140-890

Official label / PI · EA

Open original

140-890

Official label / PI · FONSI

Open original

Naxcel® Sterile Powder

SPL · SPL

Open original
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, No Use Class Stated Or Implied • Horse, Not For Meat Production • Goat, No Use Class Stated Or Implied • No use class stated or implied • Beef • Dairy • Day old poults • 1 day-old broiler chicks • Sheep, No Use Class Stated Or Implied
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

Open original
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
No use class stated or implied • Beef And Non-Lactating Dairy • Dairy, lactating
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

Open original
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
Species
No use class stated or implied • No Use Class Stated Or Implied
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

Open original
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, No Use Class Stated Or Implied • Goat, No Use Class Stated Or Implied • Swine, No Use Class Stated Or Implied • Cattle, No Use Class Stated Or Implied • No Use Class Stated Or Implied • Turkey, Poults, Day Old • Day-Old Chicks • Sheep, No Use Class Stated Or Implied

<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

Open original
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
No use class stated or implied • Cattle, Excluding Veal Calves
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

Open original
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
No use class stated or implied • Cattle, Excluding Veal Calves
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

Open original
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
No use class stated or implied • Cattle, Excluding Veal Calves
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

Open original
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, dry cows
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

Open original
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, lactating
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

Open original

ucm049846.pdf

FOI · FOI

Open original

ucm049844.pdf

FOI · FOI

Open original

ucm049843.pdf

FOI · FOI

Open original

ucm049842.pdf

FOI · FOI

Open original

ucm049841.pdf

FOI · FOI

Open original

N140338_Supp_10_25_96.pdf

FOI · FOI

Open original

UCM470933.pdf

FOI · FOI

Open original

N140338_Supp_08-24-1995.pdf

FOI · FOI

Open original

UCM539438.pdf

FOI · FOI

Open original

N140338_Supp_08_04_1992.pdf

FOI · FOI

Open original

N140338_Supp_03-15-1991.pdf

FOI · FOI

Open original

UCM490826.pdf

FOI · FOI

Open original

UCM478009.pdf

FOI · FOI

Open original

FOI Summary sN 141-288 Approved May 6, 2019.pdf

FOI · FOI

Open original

UCM377873.pdf

FOI · FOI

Open original

UCM208544.pdf

FOI · FOI

Open original

FOI Summary oA 200-616 Approved January 28, 2019.pdf

FOI · FOI

Open original

UCM307677.pdf

FOI · FOI

Open original

ucm059129.pdf

FOI · FOI

Open original

ucm059128.pdf

FOI · FOI

Open original

ucm059127.pdf

FOI · FOI

Open original

ucm059124.pdf

FOI · FOI

Open original

ucm059122.pdf

FOI · FOI

Open original

ucm059120.pdf

FOI · FOI

Open original

ucm118055.pdf

FOI · FOI

Open original

ucm118053.pdf

FOI · FOI

Open original

UCM446090.pdf

FOI · FOI

Open original

ucm118052.pdf

FOI · FOI

Open original

ucm118051.pdf

FOI · FOI

Open original

ucm118047.pdf

FOI · FOI summary

Open original

UCM235349.pdf

FOI · FOI summary

Open original

ucm117761.pdf

FOI · FOI summary

Open original

ucm117768.pdf

FOI · FOI summary

Open original

ucm117772.pdf

FOI · FOI summary

Open original

UCM203951.pdf

FOI · FOI summary

Open original

UCM307680.pdf

FOI · FOI summary

Open original
Source metadata:
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 Apr 22, 2026, 10:07 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.
Official (FDA)
Identity: Generic ingredient • No FDA branded products linked
No official FDA brand rows linked yet for this ingredient.
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, No Use Class Stated Or Implied, No use class stated or implied, 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
Documents: 38 (FOI: 30) • SPL: 9 • 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
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 51 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, 2026-04-22)
  • 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, 2026-05-05)
  • indications: Cattle: For treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus s… (Official, 2026-05-03)
  • indications: Cattle: For treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus s… (Official, 2026-05-02)
  • indications: Cattle: For treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus s… (Official, 2026-04-29)
  • indications: Cattle: For treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus s… (Official, 2026-04-28)
  • indications: Cattle: For treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus s… (Official, 2026-04-27)
  • indications: Cattle: For treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus s… (Official, 2026-04-26)
  • indications: Cattle: For treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus s… (Official, 2026-04-25)
  • indications: Cattle: For treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus s… (Official, 2026-04-22)
  • side_effects: Top reported reactions (openFDA): Abnormal cytology, Abnormal histology NOS, Corneal ulcer, Death by euthanasia, Decreased appetite, Dermal plaque. (Official, 2026-02-12)
  • usage: For treatment of respiratory infections in horses associated with Streptococcus zooepidemicus . Treatment of bovine respiratory disease (shipping fever, pneumo… (Official, 2026-04-22)
Recent Revisions
  • 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
Label highlights
Official documents
Zoetis Inc. NADA 140-338 Approved Sep 6, 2022
EXCENEL® RTU EZ
RX
Ceftiofur Hydrochloride
Liquid (Suspension) • Intramuscular, Subcutaneous
Label highlights
Official documents
Zoetis Inc. NADA 141-288 Approved Jun 3, 2019
Cefenil® RTU
RX
Ceftiofur Hydrochloride
Sterile suspension • Injection
Label highlights
Official documents
Norbrook Laboratories, Ltd. ANADA 200-616 Approved Jan 31, 2019
Ceftiofur for Injection
RX
Ceftiofur Sodium
Powder-Sterile • Subcutaneous, Intramuscular
Label highlights
Official documents
Hospira, Inc. ANADA 200-421 W Jan 16, 2018
Excenel® Sterile Powder Excenel® RTU Excenel Sterile Suspension
RX
Ceftiofur Hydrochloride
Liquid (Suspension) • Subcutaneous, Intramuscular
Label highlights
Official documents
Zoetis Inc. NADA 140-890 Approved Dec 18, 2017
Spectramast™ DC Sterile Suspension
RX
Ceftiofur Hydrochloride
Liquid (Suspension) • Intramammary
Label highlights
Official documents
Zoetis Inc. NADA 141-239 Approved Jun 1, 2016
Spectramast® LC Sterile Suspension
RX
Ceftiofur Hydrochloride
Liquid (Suspension) • Intramammary
Label highlights
Official documents
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, No Use Class Stated Or Implied • Horse, Not For Meat Production • Goat, No Use Class Stated Or Implied • No use class stated or implied • Beef • Dairy • Day old poults • 1 day-old broiler chicks • Sheep, No Use Class Stated Or Implied
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: No use class stated or implied • Beef And Non-Lactating Dairy • Dairy, lactating
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

Species: No use class stated or implied • No Use Class Stated Or Implied
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, No Use Class Stated Or Implied • Goat, No Use Class Stated Or Implied • Swine, No Use Class Stated Or Implied • Cattle, No Use Class Stated Or Implied • No Use Class Stated Or Implied • Turkey, Poults, Day Old • Day-Old Chicks • Sheep, No Use Class Stated Or Implied
<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: No use class stated or implied • Cattle, Excluding Veal Calves
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, dry cows
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, lactating
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 (21)
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 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.

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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