Active ingredient
Prasugrel
21 finished FDA listings contain Prasugrel as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- PRASUGREL, PRASUGREL HYDROCHLORIDE
- Dosage forms
- Tablet, Coated, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 11
- Strengths listed
- 10 mg/1 · 5 mg/1
- Brand names in FDA listings
- Effient
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 613391
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 022307 | COSETTE | 2009-07-10 | 2 |
| ANDA 205927 | MYLAN | 2017-07-12 | 4 |
| ANDA 205888 | AUROBINDO PHARMA | 2017-10-16 | 4 |
| ANDA 205897 | PANACEA | 2017-10-16 | 5 |
| ANDA 205987 | ACCORD HLTHCARE | 2018-02-02 | 2 |
| ANDA 205913 | AMNEAL PHARMS | 2018-06-19 | 2 |
| ANDA 213315 | UNICHEM | 2023-08-28 | 2 |
Official labeling on DailyMed
- PRASUGREL TABLET, FILM COATED [APOTEX CORP.] · version 9 · 2026-04-09
- PRASUGREL TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] · version 1 · 2025-03-03
- PRASUGREL TABLET, FILM COATED [PANACEA BIOTEC LIMITED] · version 3 · 2025-02-13
- PRASUGREL TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 1 · 2024-11-27
- PRASUGREL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] · version 4 · 2024-08-22
- PRASUGREL TABLET, FILM COATED [AMNEAL PHARMACEUTICALS LLC] · version 13 · 2024-07-11
- PRASUGREL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] · version 11 · 2024-02-02
- PRASUGREL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] · version 9 · 2024-01-31
- PRASUGREL TABLET, FILM COATED [ACCORD HEALTHCARE INC.] · version 7 · 2024-01-08
- PRASUGREL TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.] · version 4 · 2023-10-16
- EFFIENT (PRASUGREL HYDROCHLORIDE) TABLET, COATED [COSETTE PHARMACEUTICALS, INC.] · version 2 · 2022-09-09
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.