Active ingredient
Finasteride
73 finished FDA listings contain Finasteride as their only active ingredient; 3 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- FINASTERIDE
- Dosage forms
- Tablet, Tablet, Coated, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 32
- Strengths listed
- 1 mg/1 · 5 mg/1
- Brand names in FDA listings
- Propecia, Proscar
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 25025
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 020180 | ORGANON | 1992-06-19 | 1 |
| NDA 020788 | ORGANON | 1997-12-19 | 1 |
| ANDA 076436 | DR REDDYS LABS INC | 2006-07-28 | 1 |
| ANDA 076511 | TEVA | 2006-12-15 | 1 |
| ANDA 076437 | DR REDDYS LABS LTD | 2007-02-28 | 2 |
| ANDA 078341 | AUROBINDO PHARMA | 2007-10-30 | 16 |
| ANDA 090121 | ACCORD HLTHCARE | 2010-02-23 | 7 |
| ANDA 090061 | HETERO LABS LTD III | 2010-06-07 | 12 |
| ANDA 090060 | HETERO LABS LTD III | 2013-07-01 | 3 |
| ANDA 090508 | SUN PHARM | 2013-07-01 | 1 |
| ANDA 091643 | ACCORD HLTHCARE | 2013-11-05 | 2 |
| ANDA 203687 | AUROBINDO PHARMA LTD | 2013-11-05 | 8 |
| ANDA 204304 | ALKEM LABS LTD | 2017-01-05 | 10 |
| ANDA 207750 | ALKEM LABS LTD | 2017-01-06 | 8 |
Official labeling on DailyMed
- FINASTERIDE TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.] · version 12 · 2026-09-10
- FINASTERIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 11 · 2026-09-10
- FINASTERIDE TABLET, FILM COATED [QUALLENT PHARMACEUTICALS HEALTH LLC] · version 3 · 2026-09-02
- FINASTERIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] · version 22 · 2026-08-24
- FINASTERIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 106 · 2026-08-21
- FINASTERIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] · version 8 · 2026-08-20
- FINASTERIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] · version 24 · 2026-08-20
- FINASTERIDE TABLET, FILM COATED [REMEDYREPACK INC.] · version 13 · 2026-08-17
- FINASTERIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] · version 6 · 2026-08-03
- FINASTERIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] · version 6 · 2026-08-03
- FINASTERIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC] · version 25 · 2026-07-13
- FINASTERIDE TABLET, COATED [REMEDYREPACK INC.] · version 14 · 2026-07-13
Showing the 12 most recent of 71 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.