FDA Orange Book
Generic for Avalide
Avalide contains irbesartan and hydrochlorothiazide. 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 Avalide is irbesartan and hydrochlorothiazide. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 4 Avalide products the Orange Book lists.
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Avalide products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 12.5MG;150MG | Marketed (Rx) | AB | 8 | AB |
| tablet, oral | 12.5MG;300MG | Marketed (Rx) | AB | 8 | AB |
| tablet, oral | 12.5MG;75MG | Discontinued | None | 0 | None |
| tablet, oral | 25MG;300MG | Discontinued | None | 2 | AB |
NDA 020758, 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 and hydrochlorothiazide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA INC | 077369 | AB (A-rated, therapeutically equivalent) | March 30, 2012 | 12.5MG;150MG, 12.5MG;300MG |
| DR REDDYS LABORATORIES LTD | 203500 | AB (A-rated, therapeutically equivalent) | September 27, 2012 | 12.5MG;150MG, 12.5MG;300MG |
| MACLEODS PHARMACEUTICALS LTD | 202414 | AB (A-rated, therapeutically equivalent) | September 27, 2012 | 12.5MG;150MG, 12.5MG;300MG |
| SANDOZ INC | 077446 | AB (A-rated, therapeutically equivalent) | September 27, 2012 | 12.5MG;150MG, 12.5MG;300MG |
| ALEMBIC PHARMACEUTICALS LTD | 091370 | AB (A-rated, therapeutically equivalent) | October 15, 2012 | 12.5MG;150MG, 12.5MG;300MG, 25MG;300MG |
| AUROBINDO PHARMA LTD | 203630 | AB (A-rated, therapeutically equivalent) | February 22, 2013 | 12.5MG;150MG, 12.5MG;300MG, 25MG;300MG |
| PRINSTON PHARMACEUTICAL INC | 203072 | AB (A-rated, therapeutically equivalent) | May 9, 2014 | 12.5MG;150MG, 12.5MG;300MG |
| HISUN PHARMACEUTICAL (HANGZHOU) CO LTD | 207896 | AB (A-rated, therapeutically equivalent) | October 14, 2016 | 12.5MG;150MG, 12.5MG;300MG |
Avalide NDC codes
Questions
Is there a generic for Avalide?
Yes. The generic name for Avalide is irbesartan and hydrochlorothiazide. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 4 Avalide products the Orange Book lists.
What is the generic name for Avalide?
The active ingredient in Avalide is irbesartan and hydrochlorothiazide, 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.