Active ingredient
Cefazolin
48 finished FDA listings contain Cefazolin as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- CEFAZOLIN, CEFAZOLIN SODIUM
- Dosage forms
- Injection, Powder, For Solution, Injection, Powder, Lyophilized, For Solution, Injection, Solution, Powder, For Solution, Solution
- Routes
- Intramuscular, Intravenous, Parenteral
- Manufacturers / labelers
- 18
- Strengths listed
- 1 g/1 · 1 g/3ml · 1 g/50ml · 10 g/1 · 100 g/1 · 2 g/1 · 2 g/100ml · 2 g/50ml · 20 g/1 · 225 mg/ml · 3 g/1 · 3 g/150ml · 3 g/50ml · 300 g/1 · 330 mg/ml · 500 mg/1 · 500 mg/2.2ml
- Brand names in FDA listings
- Cefazolin
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2180
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 062831 | SANDOZ | 1988-12-09 | 3 |
| NDA 050779 | B BRAUN | 2000-07-27 | 3 |
| ANDA 065047 | HIKMA FARMACEUTICA | 2001-09-18 | 8 |
| ANDA 065143 | HIKMA FARMACEUTICA | 2004-10-18 | 4 |
| ANDA 065141 | SAMSON MEDCL | 2006-11-29 | 2 |
| ANDA 065345 | SANDOZ | 2007-05-09 | 1 |
| ANDA 065303 | ACS DOBFAR | 2008-10-22 | 5 |
| ANDA 065306 | ACS DOBFAR | 2008-10-22 | 2 |
| NDA 207131 | BAXTER HLTHCARE CORP | 2015-08-07 | 3 |
| ANDA 203661 | QILU ANTIBIOTICS | 2015-12-28 | 10 |
| ANDA 209217 | QILU ANTIBIOTICS | 2018-10-17 | 2 |
| NDA 216109 | HIKMA | 2022-10-07 | 3 |
| NDA 211413 | HQ SPCLT PHARMA | 2023-05-08 | 2 |
Official labeling on DailyMed
- CEFAZOLIN INJECTION, POWDER, FOR SOLUTION [CIVICA, INC.] · version 1 · 2026-08-20
- CEFAZOLIN INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] · version 13 · 2026-05-20
- CEFAZOLIN INJECTION, POWDER, FOR SOLUTION [CIVICA, INC.] · version 4 · 2026-05-20
- CEFAZOLIN INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] · version 7 · 2026-05-20
- CEFAZOLIN INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC] · version 6 · 2026-03-23
- CEFAZOLIN INJECTION, POWDER, FOR SOLUTION [CIVICA, INC.] · version 2 · 2026-01-30
- CEFAZOLIN INJECTION, POWDER, FOR SOLUTION [HOSPIRA, INC] · version 18 · 2026-01-23
- CEFAZOLIN INJECTION, POWDER, FOR SOLUTION [SANDOZ INC] · version 19 · 2026-01-21
- CEFAZOLIN INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC] · version 6 · 2026-01-08
- CEFAZOLIN INJECTION, POWDER, FOR SOLUTION [HENRY SCHEIN, INC.] · version 9 · 2025-11-17
- CEFAZOLIN INJECTION, POWDER, FOR SOLUTION [HENRY SCHEIN, INC.] · version 6 · 2025-11-17
- CEFAZOLIN INJECTION, POWDER, FOR SOLUTION [PROPHARMA DISTRIBUTION] · version 1 · 2025-08-29
Showing the 12 most recent of 31 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.