Active ingredient
Danazol
11 finished FDA listings contain Danazol as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- DANAZOL
- Dosage forms
- Capsule
- Routes
- Oral
- Manufacturers / labelers
- 4
- Strengths listed
- 100 mg/1 · 200 mg/1 · 50 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 3102
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 074582 | BARR | 1996-08-09 | 3 |
| ANDA 077246 | LANNETT CO INC | 2005-09-28 | 5 |
| ANDA 078214 | LANNETT | 2007-04-19 | 3 |
Official labeling on DailyMed
- DANAZOL CAPSULE [TEVA PHARMACEUTICALS USA, INC.] · version 15 · 2025-03-24
- DANAZOL CAPSULE [CHARTWELL RX, LLC.] · version 3 · 2024-10-14
- DANAZOL CAPSULE [LANNETT COMPANY, INC.] · version 28 · 2022-07-29
- DANAZOL CAPSULE [PROFICIENT RX LP] · version 1 · 2022-04-04
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.