Active ingredient
Terazosin
88 finished FDA listings contain Terazosin as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE ANHYDROUS
- Dosage forms
- Capsule, Solution
- Routes
- Oral
- Manufacturers / labelers
- 22
- Strengths listed
- 1 mg/1 · 1 mg/ml · 10 mg/1 · 2 mg/1 · 5 mg/1
- Brand names in FDA listings
- Terazosin, Tezruly
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 37798
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 074823 | SENORES PHARMS | 1998-03-30 | 20 |
| ANDA 075667 | BIONPHARMA | 2000-07-28 | 9 |
| ANDA 075614 | HERITAGE PHARMA AVET | 2001-01-30 | 14 |
| ANDA 075317 | JUBILANT CADISTA | 2004-12-20 | 40 |
| NDA 218139 | NOVITIUM PHARMA | 2024-07-29 | 1 |
| ANDA 219482 | AJANTA PHARMA LTD | 2025-05-12 | 4 |
Official labeling on DailyMed
- TERAZOSIN HYDROCHLORIDE CAPSULE [AMERISYN LLC] · version 1 · 2026-09-07
- TERAZOSIN HYDROCHLORIDE CAPSULE [APNAR PHARMA LP] · version 1 · 2026-08-10
- TERAZOSIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] · version 1 · 2026-07-23
- TERAZOSIN HYDROCHLORIDE CAPSULE [AMERISYN, LLC] · version 1 · 2026-07-23
- TERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK] · version 104 · 2026-07-01
- TERAZOSIN CAPSULE [BRYANT RANCH PREPACK] · version 1 · 2026-05-25
- TERAZOSIN HYDROCHLORIDE CAPSULE [AMICI PHARMA, INC.] · version 1 · 2026-05-21
- TERAZOSIN CAPSULE [REMEDYREPACK INC.] · version 7 · 2026-05-21
- TERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [REMEDYREPACK INC.] · version 15 · 2026-05-21
- TERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [REMEDYREPACK INC.] · version 14 · 2026-05-21
- TERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.] · version 8 · 2026-05-06
- TERAZOSIN CAPSULE [BRYANT RANCH PREPACK] · version 1 · 2026-04-22
Showing the 12 most recent of 47 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.