FDA Orange Book
Generic for Uroxatral
Uroxatral contains alfuzosin. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Uroxatral is alfuzosin. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Uroxatral products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 10MG | Marketed (Rx) | AB | 4 | AB |
NDA 021287, held by ADVANZ PHARMA (US) CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic alfuzosin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| APOTEX INC | 079013 | AB (A-rated, therapeutically equivalent) | July 18, 2011 | 10MG |
| INVAGEN PHARMACEUTICALS INC | 090284 | AB (A-rated, therapeutically equivalent) | January 17, 2012 | 10MG |
| AUROBINDO PHARMA LTD | 079060 | AB (A-rated, therapeutically equivalent) | August 30, 2012 | 10MG |
| UNICHEM LABORATORIES LTD | 203192 | AB (A-rated, therapeutically equivalent) | January 28, 2016 | 10MG |
Uroxatral NDC codes
Questions
Is there a generic for Uroxatral?
Yes. The generic name for Uroxatral is alfuzosin. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Uroxatral?
The active ingredient in Uroxatral is alfuzosin, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.