Prescription medicine
Cefotetan First approved as Cefotan
Cefotetan (Cefotan) is a prescription medicine with an FDA approval on record since 1985. FDA's NDC Directory lists it from 2 generic labelers.
- Generic listed
Check it at the source: the cefotetan FDA label on DailyMed (effective April 8, 2024, PAI Holdings, LLC dba PAI Pharma); the NDA 50588 record on Drugs@FDA; every cefotetan label on DailyMed.
Highlights of the record
FDA label of April 8, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageTo 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.
Forms and strengths
- 1 g
- 2 g
- 1 g/10ml
- 2 g/20ml
Injection (powder) for solution.
On the market
- Earliest approval on file
- December 27, 1985 Cefotan, Pai Holdings Pharm; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 5 first April 29, 1993; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 2 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 143 through July 30, 2026
What is cefotetan used for?
From the label: indications and usageTo 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. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. […]
Conditions named in the indications of cefotetan's FDA labels, with every medicine labeled for each:
From other cefotetan labelsUrinary tract infections: Urinary Tract Infections caused by E. coli, Klebsiella spp (including K. pneumoniae ), Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, and Morganella morganii.
FDA pharmacologic class: Cephalosporin Antibacterial.
Source: FDA drug label (Cefotan), PAI Holdings, LLC dba PAI Pharma, effective April 8, 2024 (SPL set f1510f5e-d001-44e0-accb-27cf79fd4f9a), via openFDA; the full label on DailyMed
Is there a generic for cefotetan (Cefotan)?
The FDA approved the first generic cefotetan on April 29, 1993. 5 generic applications are approved; 1 of them carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists cefotetan from 2 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1985 earliest approval on file
- 1993 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the cefotetan label say about other medicines?
The cefotetan label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Epinephrine | warnings | SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED. |
Source: FDA drug label (Cefotan), PAI Holdings, LLC dba PAI Pharma, effective April 8, 2024 (SPL set f1510f5e-d001-44e0-accb-27cf79fd4f9a), via openFDA; the full label on DailyMed
What do FAERS reports show for cefotetan?
The FDA Adverse Event Reporting System holds 143 reports that list cefotetan among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 18 are coded as a death and 71 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other cephalosporins
- the pharmacologic class, with prices and generics
- Cefotetan side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other