FDA Orange Book
Generic for Avapro
Avapro contains irbesartan. 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 Avapro is irbesartan. 15 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Avapro products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 150MG | Marketed (Rx) | AB | 15 | AB |
| tablet, oral | 300MG | Marketed (Rx) | AB | 15 | AB |
| tablet, oral | 75MG | Discontinued | None | 15 | AB |
NDA 020757, 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 irbesartan
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA | 077159 | AB (A-rated, therapeutically equivalent) | March 30, 2012 | 150MG, 300MG, 75MG |
| AUROBINDO PHARMA LTD | 203081 | AB (A-rated, therapeutically equivalent) | September 27, 2012 | 150MG, 300MG, 75MG |
| HETERO LABS LTD UNIT V | 202910 | AB (A-rated, therapeutically equivalent) | September 27, 2012 | 150MG, 300MG, 75MG |
| PRINSTON PHARMACEUTICAL INC | 203071 | AB (A-rated, therapeutically equivalent) | September 27, 2012 | 150MG, 300MG, 75MG |
| SANDOZ INC | 077466 | AB (A-rated, therapeutically equivalent) | September 27, 2012 | 150MG, 300MG, 75MG |
| ZYDUS PHARMACEUTICALS USA INC | 079213 | AB (A-rated, therapeutically equivalent) | September 27, 2012 | 150MG, 300MG, 75MG |
| MACLEODS PHARMACEUTICALS LTD | 202254 | AB (A-rated, therapeutically equivalent) | October 3, 2012 | 150MG, 300MG, 75MG |
| ALEMBIC PHARMACEUTICALS LTD | 091236 | AB (A-rated, therapeutically equivalent) | October 15, 2012 | 150MG, 300MG, 75MG |
| CHARTWELL MOLECULAR HOLDINGS LLC | 077205 | AB (A-rated, therapeutically equivalent) | November 14, 2012 | 150MG, 300MG, 75MG |
| JUBILANT GENERICS LTD | 203534 | AB (A-rated, therapeutically equivalent) | February 23, 2015 | 150MG, 300MG, 75MG |
| SCIEGEN PHARMACEUTICALS INC | 204774 | AB (A-rated, therapeutically equivalent) | December 7, 2015 | 150MG, 300MG, 75MG |
| UNICHEM LABORATORIES LTD | 203020 | AB (A-rated, therapeutically equivalent) | December 7, 2015 | 150MG, 300MG, 75MG |
| HISUN PHARMACEUTICAL (HANGZHOU) CO LTD | 206194 | AB (A-rated, therapeutically equivalent) | June 14, 2016 | 150MG, 300MG, 75MG |
| AMNEAL PHARMACEUTICALS OF NEW YORK LLC | 204740 | AB (A-rated, therapeutically equivalent) | April 17, 2018 | 150MG, 300MG, 75MG |
| MSN LABORATORIES PRIVATE LTD | 219539 | AB (A-rated, therapeutically equivalent) | November 4, 2025 | 150MG, 300MG, 75MG |
Avapro NDC codes
Questions
Is there a generic for Avapro?
Yes. The generic name for Avapro is irbesartan. 15 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 Avapro?
The active ingredient in Avapro is irbesartan, 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.