Active ingredient
Cefepime
27 finished FDA listings contain Cefepime as their only active ingredient; 1 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- CEFEPIME, CEFEPIME HYDROCHLORIDE
- Dosage forms
- Injection, Powder, For Solution, Injection, Solution
- Routes
- Intramuscular, Intravenous
- Manufacturers / labelers
- 10
- Strengths listed
- 1 g/1 · 1 g/20ml · 1 g/50ml · 100 g/1 · 2 g/1 · 2 g/20ml · 2 g/50ml · 500 mg/1
- Brand names in FDA listings
- Cefepime, Cefepime Hydrochloride And Dextrose
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 20481
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 065441 | ACS DOBFAR | 2008-03-20 | 10 |
| NDA 050817 | BAXTER HLTHCARE | 2008-08-05 | 1 |
| NDA 050821 | B BRAUN | 2010-05-06 | 2 |
| ANDA 203704 | QILU ANTIBIOTICS | 2016-02-01 | 9 |
| ANDA 209408 | SAMSON MEDCL | 2018-08-21 | 1 |
| ANDA 214402 | HIKMA | 2024-05-22 | 4 |
Official labeling on DailyMed
- CEFEPIME INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC] · version 17 · 2026-07-03
- CEFEPIME INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] · version 29 · 2026-07-01
- CEFEPIME INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC] · version 8 · 2026-06-30
- CEFEPIME HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] · version 1 · 2026-06-22
- CEFEPIME HYDROCHLORIDE AND DEXTROSE (CEFEPIME HYDROCHLORIDE) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.] · version 25 · 2026-04-22
- CEFEPIME HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] · version 3 · 2025-11-17
- CEFEPIME INJECTION, POWDER, FOR SOLUTION [HOSPIRA, INC.] · version 4 · 2024-11-08
- CEFEPIME INJECTION, POWDER, FOR SOLUTION [SAMSON MEDICAL TECHNOLOGIES LLC] · version 7 · 2024-03-14
- CEFEPIME INJECTION, POWDER, FOR SOLUTION CEFEPIME (CEFEPIME) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC] · version 11 · 2023-10-16
- CEFEPIME INJECTION, POWDER, FOR SOLUTION [APOTEX CORP.] · version 7 · 2023-05-12
- CEFEPIME INJECTION, POWDER, FOR SOLUTION [APOTEX CORP.] · version 10 · 2023-05-12
- CEFEPIME INJECTION, POWDER, FOR SOLUTION [APOTEX CORP.] · version 2 · 2023-05-12
Showing the 12 most recent of 13 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.