Active ingredient
Fosinopril
21 finished FDA listings contain Fosinopril as their only active ingredient; 4 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- FOSINOPRIL SODIUM
- Dosage forms
- Tablet
- Routes
- Oral
- Manufacturers / labelers
- 7
- Strengths listed
- 10 mg/1 · 20 mg/1 · 40 mg/1
- Brand names in FDA listings
- Fosinopril Sodium
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 50166
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 076483 | CHARTWELL RX | 2004-04-23 | 3 |
| ANDA 077222 | INVAGEN PHARMS | 2005-04-20 | 9 |
| ANDA 091163 | AUROBINDO PHARMA LTD | 2011-03-30 | 3 |
| ANDA 205670 | PRINSTON INC | 2016-08-29 | 6 |
Official labeling on DailyMed
- FOSINOPRIL SODIUM TABLET [CHARTWELL RX, LLC] · version 4 · 2025-11-17
- FOSINOPRIL SODIUM (FOSINOPIRL SODIUM) TABLET FOSINOPRIL SODIUM TABLET [SOLCO HEALTHCARE LLC] · version 3 · 2025-09-12
- FOSINOPRIL SODIUM TABLET [AUROBINDO PHARMA LIMITED] · version 8 · 2024-05-20
- FOSINOPRIL SODIUM (FOSINOPIRL SODIUM) TABLET [BRYANT RANCH PREPACK] · version 7 · 2023-11-28
- FOSINOPRIL SODIUM (FOSINOPRIL) TABLET [BRYANT RANCH PREPACK] · version 102 · 2023-11-28
- FOSINOPRIL SODIUM (FOSINOPRIL) TABLET [BRYANT RANCH PREPACK] · version 9 · 2023-10-20
- FOSINOPRIL SODIUM TABLET [A-S MEDICATION SOLUTIONS] · version 7 · 2023-09-26
- FOSINOPRIL SODIUM TABLET [BRYANT RANCH PREPACK] · version 100 · 2023-05-25
- FOSINOPRIL SODIUM TABLET [EXELAN PHARMACEUTICALS, INC.] · version 8 · 2023-03-24
- FOSINOPRIL SODIUM (FOSINOPRIL) TABLET [A-S MEDICATION SOLUTIONS] · version 19 · 2023-02-20
- FOSINOPRIL SODIUM (FOSINOPRIL) TABLET [CIPLA USA INC.] · version 6 · 2023-01-23
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.