Active ingredient
Doxazosin
129 finished FDA listings contain Doxazosin as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- DOXAZOSIN MESYLATE
- Dosage forms
- Tablet, Tablet, Film Coated, Extended Release
- Routes
- Oral
- Manufacturers / labelers
- 32
- Strengths listed
- 1 mg/1 · 2 mg/1 · 4 mg/1 · 8 mg/1
- Brand names in FDA listings
- Cardura, Cardura Xl, Doxazosin
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 49276
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 019668 | VIATRIS | 1990-11-02 | 17 |
| ANDA 075646 | CHARTWELL RX | 2000-10-18 | 4 |
| ANDA 075580 | APOTEX | 2000-10-18 | 34 |
| ANDA 075536 | TEVA | 2000-10-18 | 10 |
| ANDA 075509 | AUROBINDO PHARMA USA | 2000-10-19 | 4 |
| NDA 021269 | VIATRIS | 2005-02-22 | 2 |
| ANDA 202824 | ACCORD HLTHCARE | 2014-06-11 | 17 |
| ANDA 208719 | ZYDUS PHARMS | 2017-07-07 | 14 |
| ANDA 205210 | HERITAGE PHARMA | 2018-02-13 | 9 |
| ANDA 209013 | SOMERSET THERAPS LLC | 2018-04-17 | 9 |
| ANDA 212727 | RISING | 2022-03-15 | 4 |
| ANDA 212329 | UNICHEM | 2024-01-10 | 5 |
Official labeling on DailyMed
- DOXAZOSIN TABLET [MAJOR PHARMACEUTICALS] · version 14 · 2026-08-20
- DOXAZOSIN TABLET [REMEDYREPACK INC.] · version 6 · 2026-08-17
- DOXAZOSIN MESYLATE TABLET DOXAZOSIN TABLET [MYLAN PHARMACEUTICALS INC.] · version 19 · 2026-08-06
- DOXAZOSIN MESYLATE TABLET [MYLAN PHARMACEUTICALS INC.] · version 3 · 2026-08-05
- DOXAZOSIN TABLET [A-S MEDICATION SOLUTIONS] · version 33 · 2026-07-20
- CARDURA (DOXAZOSIN) TABLET [VIATRIS SPECIALTY LLC] · version 3 · 2026-07-16
- CARDURA (DOXAZOSIN MESYLATE) TABLET CARDURA (DOXAZOSIN) TABLET [ROERIG] · version 26 · 2026-07-16
- DOXAZOSIN TABLET [REMEDYREPACK INC.] · version 19 · 2026-07-10
- DOXAZOSIN TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] · version 1 · 2026-06-25
- DOXAZOSIN TABLET [REMEDYREPACK INC.] · version 5 · 2026-06-15
- DOXAZOSIN TABLET [REMEDYREPACK INC.] · version 5 · 2026-06-15
- DOXAZOSIN TABLET [PD-RX PHARMACEUTICALS, INC.] · version 21 · 2026-05-15
Showing the 12 most recent of 67 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.