Quick answers
- What is Cefotetan used for?
- The FDA-approved label (Cefotan, PAI Holdings, LLC dba PAI Pharma, April 8, 2024) says: “To reduce the development of drug-resistant bacteria and maintain the effectiveness of CEFOTAN ® and other antibacterial drugs, CEFOTAN ® should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Cefotetan have a boxed warning?
- No. None of the 3 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Cefotetan?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Cefotetan been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Cefotetan?
- 3 companies list prescription products of Cefotetan in the FDA NDC Directory, including PAI Holdings, LLC dba PAI Pharma, Fresenius Kabi USA, LLC and Hikma Pharmaceuticals USA Inc..
What Cefotetan is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of CEFOTAN ® and other antibacterial drugs, CEFOTAN ® should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. …
— FDA label: Cefotan, PAI Holdings, LLC dba PAI Pharma, effective April 8, 2024. Read the full label on DailyMed →
The FDA has 3 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 3 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, for solution |
|---|---|
| Route | Intramuscular · Intravenous |
| Prescription products | 6 in the FDA NDC Directory |
| Brand names | Cefotan |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- PAI Holdings, LLC dba PAI Pharma2 products
- Fresenius Kabi USA, LLC2 products
- Hikma Pharmaceuticals USA Inc.2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA050588 CEFOTAN | Pai Holdings Pharm | December 27, 1985 | 17, latest March 9, 2017 2017: Labeling · 2015: Manufacturing (CMC) · 2004: Labeling |
Generic approvals (2)
- ANDA065374Fresenius Kabi USA · August 9, 2007
- ANDA091031Hikma · October 26, 2011
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1722919, 1722921, 1731542, 1743557 |
|---|---|
| SPL set ID of the quoted label | f1510f5e-d001-44e0-accb-27cf79fd4f9a |
| FDA labels (SPL) | 3 |
| FDA applications | NDA050588, 2 ANDA |
| Active ingredients (FDA) | CEFOTETAN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Cefotan, PAI Holdings, LLC dba PAI Pharma, effective April 8, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →