Active ingredient
Alfuzosin
17 finished FDA listings contain Alfuzosin as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ALFUZOSIN HYDROCHLORIDE
- Dosage forms
- Tablet, Tablet, Extended Release, Tablet, Film Coated, Extended Release
- Routes
- Oral
- Manufacturers / labelers
- 11
- Strengths listed
- 10 mg/1
- Brand names in FDA listings
- Alfuzosin Hydrochloride Extended Release, Uroxatral
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 17300
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 021287 | ADVANZ PHARMA | 2003-06-12 | 1 |
| ANDA 079057 | SUN PHARM | 2011-07-18 | 4 |
| ANDA 079013 | APOTEX INC | 2011-07-18 | 1 |
| ANDA 090284 | INVAGEN PHARMS | 2012-01-17 | 3 |
| ANDA 079060 | AUROBINDO PHARMA LTD | 2012-08-30 | 5 |
| ANDA 203192 | UNICHEM | 2016-01-28 | 3 |
Official labeling on DailyMed
- ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [APOTEX CORP.] · version 18 · 2026-09-07
- ALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED] · version 14 · 2026-07-27
- ALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED] · version 1 · 2026-07-13
- ALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK] · version 2 · 2026-05-11
- ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [NORTHWIND HEALTH COMPANY, LLC] · version 2 · 2026-01-30
- ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [NORTHWIND HEALTH COMPANY, LLC] · version 4 · 2026-01-28
- ALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [RISING PHARMA HOLDINGS, INC.] · version 8 · 2026-01-28
- ALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [NORTHWIND HEALTH COMPANY, LLC] · version 2 · 2026-01-16
- UROXATRAL (ALFUZOSIN HCL) TABLET, EXTENDED RELEASE [ADVANZ PHARMA (US) CORP.] · version 9 · 2025-01-03
- ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK] · version 100 · 2024-07-18
- ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [EXELAN PHARMACEUTICALS INC.] · version 11 · 2024-06-05
- ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK] · version 103 · 2024-05-24
Showing the 12 most recent of 17 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.