Active ingredient
Cefprozil
23 finished FDA listings contain Cefprozil as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- CEFPROZIL
- Dosage forms
- Powder, For Suspension, Tablet, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 7
- Strengths listed
- 125 mg/5ml · 250 mg/1 · 250 mg/5ml · 500 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 19552
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 065208 | TEVA | 2005-12-06 | 2 |
| ANDA 065276 | LUPIN | 2005-12-08 | 2 |
| ANDA 065261 | LUPIN | 2005-12-19 | 3 |
| ANDA 065381 | AUROBINDO PHARMA | 2007-01-30 | 7 |
| ANDA 065340 | AUROBINDO PHARMA | 2007-05-24 | 7 |
| ANDA 090857 | ALKEM LABS LTD | 2024-04-09 | 2 |
Official labeling on DailyMed
- CEFPROZIL POWDER, FOR SUSPENSION [NORTHSTAR RX LLC] · version 9 · 2026-07-13
- CEFPROZIL POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] · version 1 · 2026-05-06
- CEFPROZIL TABLET [LUPIN PHARMACEUTICALS, INC.] · version 10 · 2025-11-17
- CEFPROZIL POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] · version 9 · 2025-11-17
- CEFPROZIL TABLET, FILM COATED [ASCEND LABORATORIES, LLC] · version 6 · 2025-06-05
- CEFPROZIL TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] · version 10 · 2025-01-31
- CEFPROZIL POWDER, FOR SUSPENSION [RISING PHARMA HOLDINGS, INC.] · version 7 · 2024-05-24
- CEFPROZIL POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED] · version 12 · 2024-05-21
- CEFPROZIL TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.] · version 7 · 2024-05-09
- CEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] · version 11 · 2024-05-07
- CEFPROZIL TABLET, FILM COATED [NORTHSTAR RX LLC] · version 7 · 2024-05-07
- CEFPROZIL POWDER, FOR SUSPENSION [A-S MEDICATION SOLUTIONS] · version 4 · 2024-01-31
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.