Active ingredient
Cefotetan
6 finished FDA listings contain Cefotetan as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- CEFOTETAN, CEFOTETAN DISODIUM
- Dosage forms
- Injection, Powder, For Solution
- Routes
- Intramuscular, Intravenous
- Manufacturers / labelers
- 3
- Strengths listed
- 1 g/1 · 1 g/10ml · 2 g/1 · 2 g/20ml
- Brand names in FDA listings
- Cefotan, Cefotetan
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2187
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 050588 | PAI HOLDINGS PHARM | 1985-12-27 | 2 |
| ANDA 065374 | FRESENIUS KABI USA | 2007-08-09 | 2 |
| ANDA 091031 | HIKMA | 2011-10-26 | 2 |
Official labeling on DailyMed
- CEFOTETAN (CEFOTETAN DISODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC] · version 9 · 2025-01-16
- CEFOTETAN INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] · version 4 · 2024-04-15
- CEFOTAN (CEFOTETAN) INJECTION, POWDER, FOR SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] · version 6 · 2024-04-10
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.