Active ingredient
Cefotaxime
6 finished FDA listings contain Cefotaxime as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- CEFOTAXIME SODIUM
- Dosage forms
- Injection, Injection, Powder, For Solution, Powder, For Solution
- Routes
- Intramuscular, Intravenous
- Manufacturers / labelers
- 2
- Strengths listed
- 1 g/1 · 10 g/1 · 2 g/1 · 500 mg/1
- Brand names in FDA listings
- Cefotaxime
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2186
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 |
|---|---|---|---|
| ANDA 065072 | HIKMA | 2002-11-20 | 3 |
| ANDA 065071 | HIKMA | 2002-11-20 | 1 |
Official labeling on DailyMed
- CEFOTAXIME (CEFOTAXIME INJECTION) POWDER, FOR SOLUTION [STERIMAX INC.] · version 7 · 2026-06-17
- CEFOTAXIME INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] · version 14 · 2024-04-15
- CEFOTAXIME INJECTION [HIKMA PHARMACEUTICALS USA INC.] · version 9 · 2024-04-15
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.