Meds A-Z
Ceftiofur Sodium
Detailed information about Ceftiofur Sodium
Pet Owner Quick Guide
Start here: what this medicine is for, what it does, and when it's usually needed.
Usually used for:
For treatment of respiratory infections in horses associated with Streptococcus zooepidemicus .
What it does:
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 ,...
When it's needed:
For treatment of respiratory infections in horses associated with Streptococcus zooepidemicus .
Commonly reported reactions:
- (2 reports)
- (2 reports)
- (1 reports)
What to 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?
Ceftiofur Sodium
Drug type: Generic ingredient • Branded profile • FDA branded products available
Species: Both
Manufacturer: MSK
Quick Facts
Official label facts first, then secondary summaries. Marketing content is separated below.
- https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/140338 · official_label · FDA application profile
- https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/200421 · official_label · FDA application profile
- https://animaldrugsatfda.fda.gov · fda_animal_drugs · Medication usage source
Warnings / Contraindications
No contraindication summary is linked yet.
No owner-focused warning rows are linked yet.
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.
Most Reported Reactions
| Reaction | Cases | Species | Serious cases |
|---|---|---|---|
| 2 | Cat, Dog | 2 | |
| 2 | Cat, Dog | 2 | |
| 1 | Dog | 1 | |
| 1 | Cat | 1 | |
| 1 | Cat | 1 | |
| 1 | Dog | 1 | |
| 1 | Dog | 1 | |
| 1 | Dog | 1 |
Species coverage: Dog (23) Cat (9)
View detailed reaction table
| Reaction | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Serious | - | 1 |
- https://api.fda.gov/animalandveterinary/event.json · adverse_reaction · openFDA case USA-USFDACVM-2024-US-062683
Storage & Handling
No storage/handling guidance is linked yet.
Documents
Official label facts are separated from secondary summaries.
Official documents: 21 • Secondary summaries: 0
- ucm049847.pdf · FOI
- ucm049846.pdf · FOI
- ucm049844.pdf · FOI
- ucm049843.pdf · FOI
- ucm049842.pdf · FOI
- ucm049841.pdf · FOI
- N140338_Supp_10_25_96.pdf · FOI
- UCM470933.pdf · FOI
- N140338_Supp_08-24-1995.pdf · FOI
- UCM539438.pdf · FOI
- N140338_Supp_08_04_1992.pdf · FOI
- N140338_Supp_03-15-1991.pdf · FOI
- UCM490826.pdf · FOI
- UCM478009.pdf · FOI
- 140-338 · EA
- 140-338 · FONSI
- 140-338 · EA
- 140-338 · FONSI
- Naxcel® Sterile Powder · SPL
- UCM307677.pdf · FOI
- Ceftiofur for Injection · SPL
No source yet.
- 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
Promotional Materials (Marketing)
This content is marketing material and not clinical guidance.
No marketing assets are linked yet.
No source yet.
Technical appendix (vet reference)
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.
- Medication catalog: Source PetWisePlus | Refreshed Feb 12, 2026, 10:44 PM UTC
-
Animal Drugs @ FDA:
Source FDA
| Refreshed Feb 16, 2026, 11:00 AM UTC
Applications/products are imported from FDA export data.
-
Animal Drugs @ FDA previews:
Source FDA
| Refreshed Feb 9, 2026, 3:05 AM UTC
Label highlights/doc links are fetched from FDA preview endpoints.
-
Animal Drug Product Listing Directory (NDC):
Source FDA
| Refreshed Feb 16, 2026, 11:00 AM UTC
Package/product NDCs from FDA’s electronic listing directory (XLS).
- openFDA reaction terms: Source FDA openFDA | Refreshed Feb 9, 2026, 3:14 AM UTC
- openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:21 AM UTC
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.
Identifiers & Packages
Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.
| Package NDC | Product NDC | Form / Route | Status |
|---|---|---|---|
| 54771-3362-1 | 54771 | - | |
| 54771-3362-2 | 54771 | - | |
| 58597-8170-9 | 58597 | - | |
| 62157-171-01 | 62157 | - | |
| 62157-396-01 | 62157 | - |
Enriched Documents
Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.
-
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
-
UCM307677.pdf
• FOI summary • Official
• Jan. 16, 2018
FDA FOI summary for application 200421
Data Sources & Revision History
Every non-trivial field is expected to include provenance and update timestamps.
- side_effects: Top reported reactions (openFDA): Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Death, Leucocytosis NOS, Anaemia NOS, Elev… (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, 2026-02-12)
- side_effects 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 |
|
Ceftiofur for Injection
RX
Ceftiofur Sodium
Powder-Sterile
• Subcutaneous, Intramuscular
|
Hospira, Inc. | ANADA 200-421 | W | Jan 16, 2018 |
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.
Composition / specifications
For treatment of acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus.
FDA page: Open in Animal Drugs @ FDA
FDA page: Open in Animal Drugs @ FDA
Official Documents (FDA)
Direct links to FDA-hosted PDFs and SPL packages (when available).
-
FOI ucm049847.pdf
Summary
To establish a 4-day pre-slaughter withdrawal period for cattle -
FOI ucm049846.pdf
Summary
For the treatment and control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus (Haemophilus) pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis, and Streptococcus suis type 2. -
FOI ucm049844.pdf
Summary
This supplement updates survey microbiological data and adds the National Committee for Clinical Laboratory Standards’ (NCCLS) interpretive criteria for equine isolates to the NAXCEL Sterile Powder package insert. -
FOI ucm049843.pdf
Summary
This supplement provides four specific changes to the product insert, 1) revision of the “clinical microbiology” section to update the MIC table using the new MIC data for ceftiofur, 2) the addition of a table listing acceptable quality control ranges for ceftiofur, 3) the addition of the latest National Committee for Clinical Laboratory Standards (NCCLS) reference at the end of the insert, and 4) clarification of the statement under “Storage Conditions” dealing with the storage of reconstituted Naxcel via freezing. -
FOI ucm049842.pdf
Summary
Provides for the use of a subcutaneous (SC) route of administration for NAXCEL® Sterile Powder in cattle. -
FOI ucm049841.pdf
Summary
The approval of this supplement will allow for the use of ceftiofur sodium (NAXCEL? Sterile Powder) for the treatment of bacterial pneumonia in goats to be added to the previously approved NAXCEL label. -
Summary
The approval of this supplement will allow for the use of ceftiofur sodium (NAXCEL Sterile Powder) for the treatment of bacterial pneumonia in sheep.
-
FOI UCM470933.pdf
Summary
Provides for an additional species, day-old turkey poults, to be added to the previously approved product, NAXCEL® Sterile Powder; also provides for revision of the chick indication. -
Summary
Provides for the use of ceftiofur sodium (NAXCEL® Sterile Powder) in cattle for a new indication.
-
FOI UCM539438.pdf
Summary
The supplement provides data in support of a request for approval of Naxcel ® Sterile Powder for an additional species (equine). The issue of the Freedom of Information (FOI) Summary should be considered an extension of previously approved version describing data in support of Naxcelreg., NADA 140-338, approved as a treatment for respiratory disease in cattle January 25, 1988. -
Summary
This supplement provides for an additional species, swine, to be added to the previously approved product, NAXCEL®.
-
Summary
Provides for the use of ceftiofur sodium (NAXCEL Sterile Powder) in lactating dairy cattle, a new class of animal, for the same indications approved in the parent NADA.
-
FOI UCM490826.pdf
Summary
This supplemental application provides for a change in the approved dosage of 0.5 mg/lb body weight to a range of 0.5 mg to 1.0 mg ceftiofur sodium/lb of body weight. -
FOI UCM478009.pdf
Summary
Naxcel Sterile Powder is indicated for treatment of bovine respiratory disease (shipping fever, pneumonia). -
EA 140-338
-
FONSI 140-338
-
EA 140-338
-
FONSI 140-338
- Naxcel® Sterile Powder (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
FOI UCM307677.pdf
Summary
Cattle: 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.
Swine: For treatment/control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus (Haemophilus) pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis, and Streptococcus suis.
Sheep: For treatment of sheep respiratory disease (sheep pneumonia) associated with Mannheimia haemolytica and Pasteurella multocida.
Goats: For treatment of caprine respiratory disease (goat pneumonia) associated with Mannheimia haemolytica and Pasteurella multocida.
Horses: For treatment of respiratory infections in horses associated with Streptococcus zooepidemicus.
Dogs: For the treatment of canine urinary tract infections associated with Escherichia coli and Proteus mirabilis.
Day-Old Chicks: For the control of early mortality, associated with E. coli organisms susceptible to ceftiofur, in day-old chicks.
Day-Old Turkey Poults: For the control of early mortality, associated with E. coli organisms susceptible to ceftiofur, in day-old turkey poults.orum and Bacteroides melaninogenicus.
- Ceftiofur for Injection (ZIP)
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
No approved contraindication text is linked yet. Review FDA label highlights and openFDA safety reports before making treatment decisions.
Side Effects
No approved side-effect narrative is linked yet.
openFDA reaction signals are available for Dog 8 and Cat 8 (view top reported reactions).
Top Reported Reactions (openFDA)
Aggregated reaction terms from FDA openFDA reports (not verified; does not prove causation).
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, Affenpinscher, Male, 9 year, 7.5 kilogram • Drug: MSK, Unknown • Reactions: Loss of appetite, Constipation, Liver disorder NOS, Elevated serum alkaline phosphatase, Elevated gamma-glutamyl transferase… • Outcome: Recovered/Normal
- Report ID: USA-USFDACVM-2025-US-009374
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Male
- Age: 9.00 Year
- Weight: 7.500 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
Cat, Domestic Shorthair, Female, 4 year, 5.271 kilogram • Drug: MSK, Powder, Subcutaneous, Dose: 0.30 mL per animal • Reactions: Dehydration, Death by euthanasia, Fever, Not eating, Not drinking… • Outcome: Euthanized
- Report ID: USA-USFDACVM-2025-US-006900
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Female
- Age: 4.00 Year
- Weight: 5.271 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Subcutaneous
- Form: Powder
- Dose: 0.30 mL per animal
Dog, ['Chinese Crested Dog (unspecified)', 'Dog (unknown)'], Male, 4 year, 9.11 kilogram • Drug: MSK, Unknown • Reactions: Vomiting, Lateral recumbency, Dull reflexes, Tachypnoea, Liver failure… • Outcome: Recovered/Normal
- Report ID: USA-USFDACVM-2024-US-078217
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Male
- Age: 4.00 Year
- Weight: 9.110 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
Dog, Shepherd Dog - German, Male, 1 year, 27.6 kilogram • Drug: MSK, Powder, Unknown • Reactions: Lack of efficacy (virus) - parvovirus, Paraphimosis • Outcome: Recovered/Normal
- Report ID: USA-USFDACVM-2024-US-079903
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Male
- Age: 1.00 Year
- Weight: 27.600 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
- Form: Powder
Dog, Shepherd Dog - German, Male, 1 year, 27.6 kilogram • Drug: MSK, Unknown • Reactions: Lack of efficacy (virus) - parvovirus, Paraphimosis • Outcome: Outcome Unknown
- Report ID: USA-USFDACVM-2024-US-067873
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Male
- Age: 1.00 Year
- Weight: 27.600 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
Dog, ['Crossbred Canine/dog', 'Maltese'], Female, 8 year, 8.165 kilogram • Drug: MSK, Injection, Subcutaneous, Dose: 20 Milligram per dose, Frequency: 1 per day • Reactions: Lack of efficacy - NOS, Anaemia NOS, Death by euthanasia, Elevated amylase, Hypophosphataemia… • Outcome: Euthanized
- Report ID: USA-USFDACVM-2024-US-062683
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Female
- Age: 8.00 Year
- Weight: 8.165 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Subcutaneous
- Form: Injection
- Dose: 20 Milligram per dose
- Frequency: 1 per day
Cat, Domestic Shorthair, Female, 8 year • Drug: MSK, Powder, Unknown, Dose: 20 Milligram per unknown • Reactions: Seizure NOS, Drug administration error • Outcome: Outcome Unknown
- Report ID: USA-USFDACVM-2021-US-027414
- Serious AE: No
- Treated For AE: No
- Sex: Female
- Age: 8.00 Year
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
- Form: Powder
- Dose: 20 Milligram per unknown
Cat, Domestic Shorthair, Female, 5 year, 4.536 kilogram • Drug: MSK, Powder, Subcutaneous • Reactions: Fever, Injection site lesion, Injection site necrosis, Decreased appetite, Not drinking… • Outcome: Ongoing
- Report ID: USA-USFDACVM-2018-US-042162
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Female
- Age: 5.00 Year
- Weight: 4.536 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Subcutaneous
- Form: Powder
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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