FDA Orange Book
Generic for Cardura
Cardura contains doxazosin. 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 Cardura is doxazosin. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Cardura products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 1MG BASE | Marketed (Rx) | AB | 9 | AB |
| tablet, oral | EQ 2MG BASE | Marketed (Rx) | AB | 9 | AB |
| tablet, oral | EQ 4MG BASE | Marketed (Rx) | AB | 9 | AB |
| tablet, oral | EQ 8MG BASE | Marketed (Rx) | AB | 9 | AB |
NDA 019668, held by VIATRIS SPECIALTY LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic doxazosin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| APOTEX INC | 075580 | AB (A-rated, therapeutically equivalent) | October 18, 2000 | EQ 1MG BASE, EQ 2MG BASE, EQ 4MG BASE, EQ 8MG BASE |
| TEVA PHARMACEUTICALS USA INC | 075536 | AB (A-rated, therapeutically equivalent) | October 18, 2000 | EQ 1MG BASE, EQ 2MG BASE, EQ 4MG BASE, EQ 8MG BASE |
| AUROBINDO PHARMA USA INC | 075509 | AB (A-rated, therapeutically equivalent) | October 19, 2000 | EQ 1MG BASE, EQ 2MG BASE, EQ 4MG BASE, EQ 8MG BASE |
| ACCORD HEALTHCARE INC | 202824 | AB (A-rated, therapeutically equivalent) | June 11, 2014 | EQ 1MG BASE, EQ 2MG BASE, EQ 4MG BASE, EQ 8MG BASE |
| ZYDUS PHARMACEUTICALS USA INC | 208719 | AB (A-rated, therapeutically equivalent) | July 7, 2017 | EQ 1MG BASE, EQ 2MG BASE, EQ 4MG BASE, EQ 8MG BASE |
| HERITAGE PHARMA LABS INC | 205210 | AB (A-rated, therapeutically equivalent) | February 13, 2018 | EQ 1MG BASE, EQ 2MG BASE, EQ 4MG BASE, EQ 8MG BASE |
| SOMERSET THERAPEUTICS LLC | 209013 | AB (A-rated, therapeutically equivalent) | April 17, 2018 | EQ 1MG BASE, EQ 2MG BASE, EQ 4MG BASE, EQ 8MG BASE |
| RISING PHARMA HOLDINGS INC | 212727 | AB (A-rated, therapeutically equivalent) | March 15, 2022 | EQ 1MG BASE, EQ 2MG BASE, EQ 4MG BASE, EQ 8MG BASE |
| UNICHEM LABORATORIES LTD | 212329 | AB (A-rated, therapeutically equivalent) | January 10, 2024 | EQ 1MG BASE, EQ 2MG BASE, EQ 4MG BASE, EQ 8MG BASE |
Cardura NDC codes
Questions
Is there a generic for Cardura?
Yes. The generic name for Cardura is doxazosin. 9 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 Cardura?
The active ingredient in Cardura is doxazosin, 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.