FDA Orange Book
Generic for Flomax
Flomax contains tamsulosin. 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 Flomax is tamsulosin. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Flomax products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 0.4MG | Discontinued | None | 11 | AB |
NDA 020579, held by SANOFI AVENTIS US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic tamsulosin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| IMPAX LABORATORIES INC | 090377 | AB (A-rated, therapeutically equivalent) | March 2, 2010 | 0.4MG |
| SCIEGEN PHARMACEUTICALS INC | 078938 | AB (A-rated, therapeutically equivalent) | April 27, 2010 | 0.4MG |
| SYNTHON BV | 078801 | AB (A-rated, therapeutically equivalent) | April 27, 2010 | 0.4MG |
| TEVA PHARMACEUTICALS USA | 077630 | AB (A-rated, therapeutically equivalent) | April 27, 2010 | 0.4MG |
| ZYDUS PHARMACEUTICALS USA INC | 078225 | AB (A-rated, therapeutically equivalent) | April 27, 2010 | 0.4MG |
| AUROBINDO PHARMA LTD | 202433 | AB (A-rated, therapeutically equivalent) | April 30, 2013 | 0.4MG |
| MACLEODS PHARMACEUTICALS LTD | 204645 | AB (A-rated, therapeutically equivalent) | January 20, 2017 | 0.4MG |
| ALKEM LABORATORIES LTD | 207405 | AB (A-rated, therapeutically equivalent) | August 11, 2017 | 0.4MG |
| CHARTWELL RX SCIENCES LLC | 211885 | AB (A-rated, therapeutically equivalent) | October 17, 2019 | 0.4MG |
| ASCENT PHARMACEUTICALS INC | 214730 | AB (A-rated, therapeutically equivalent) | May 4, 2022 | 0.4MG |
| RISING PHARMA HOLDINGS INC | 219767 | AB (A-rated, therapeutically equivalent) | May 1, 2025 | 0.4MG |
Questions
Is there a generic for Flomax?
Yes. The generic name for Flomax is tamsulosin. 11 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 Flomax?
The active ingredient in Flomax is tamsulosin, 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.