Active ingredient
Dutasteride
21 finished FDA listings contain Dutasteride as their only active ingredient; 4 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- DUTASTERIDE
- Dosage forms
- Capsule, Capsule, Liquid Filled
- Routes
- Oral
- Manufacturers / labelers
- 13
- Strengths listed
- .5 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 228790
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 202660 | AUROBINDO PHARMA LTD | 2015-11-20 | 2 |
| ANDA 203118 | AMNEAL PHARMS | 2015-11-20 | 2 |
| ANDA 204262 | ONESOURCE | 2015-11-20 | 1 |
| ANDA 204705 | PHARMOBEDIENT | 2015-11-20 | 1 |
| ANDA 206574 | ASCENT PHARMS INC | 2016-10-21 | 10 |
| ANDA 204376 | MARKSANS PHARMA | 2017-04-07 | 1 |
| ANDA 209909 | HUMANWELL PURACAP | 2017-11-21 | 4 |
Official labeling on DailyMed
- DUTASTERIDE CAPSULE, LIQUID FILLED [STRIDES PHARMA SCIENCE LIMITED] · version 9 · 2026-08-28
- DUTASTERIDE CAPSULE, LIQUID FILLED [BRYANT RANCH PREPACK] · version 8 · 2026-08-17
- DUTASTERIDE CAPSULE [BANYAN PHARMA LLC] · version 3 · 2026-07-31
- DUTASTERIDE CAPSULE, LIQUID FILLED [BRYANT RANCH PREPACK] · version 107 · 2026-06-15
- DUTASTERIDE CAPSULE, LIQUID FILLED [BRYANT RANCH PREPACK] · version 107 · 2026-06-01
- DUTASTERIDE CAPSULE, LIQUID FILLED [A-S MEDICATION SOLUTIONS] · version 3 · 2026-01-14
- DUTASTERIDE CAPSULE, LIQUID FILLED [A-S MEDICATION SOLUTIONS] · version 10 · 2025-12-17
- DUTASTERIDE CAPSULE, LIQUID FILLED [BRYANT RANCH PREPACK] · version 102 · 2025-10-03
- DUTASTERIDE CAPSULE, LIQUID FILLED [AUROBINDO PHARMA LIMITED] · version 3 · 2025-09-15
- DUTASTERIDE CAPSULE, LIQUID FILLED [NUCARE PHARMACEUTICALS, INC.] · version 1 · 2025-06-04
- DUTASTERIDE CAPSULE, LIQUID FILLED [NUCARE PHARMACEUTICALS, INC.] · version 1 · 2025-01-10
- DUTASTERIDE CAPSULE, LIQUID FILLED [EPIC PHARMA, LLC] · version 3 · 2025-01-10
Showing the 12 most recent of 21 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.