FDA Orange Book
Generic for Benicar HCT
Benicar HCT contains olmesartan medoxomil 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 Benicar HCT is olmesartan medoxomil and hydrochlorothiazide. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Benicar HCT products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 12.5MG;20MG | Marketed (Rx) | AB | 12 | AB |
| tablet, oral | 12.5MG;40MG | Marketed (Rx) | AB | 12 | AB |
| tablet, oral | 25MG;40MG | Marketed (Rx) | AB | 12 | AB |
NDA 021532, held by COSETTE PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic olmesartan medoxomil and hydrochlorothiazide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ALEMBIC PHARMACEUTICALS LTD | 204233 | AB (A-rated, therapeutically equivalent) | April 24, 2017 | 12.5MG;20MG, 12.5MG;40MG, 25MG;40MG |
| AUROBINDO PHARMA LTD | 205391 | AB (A-rated, therapeutically equivalent) | April 24, 2017 | 12.5MG;20MG, 12.5MG;40MG, 25MG;40MG |
| PRINSTON PHARMACEUTICAL INC | 207804 | AB (A-rated, therapeutically equivalent) | April 24, 2017 | 12.5MG;20MG, 12.5MG;40MG, 25MG;40MG |
| ACCORD HEALTHCARE INC | 209281 | AB (A-rated, therapeutically equivalent) | February 7, 2019 | 12.5MG;20MG, 12.5MG;40MG, 25MG;40MG |
| PHARMAZONE | 208847 | AB (A-rated, therapeutically equivalent) | September 17, 2019 | 12.5MG;20MG, 12.5MG;40MG, 25MG;40MG |
| MACLEODS PHARMACEUTICALS LTD | 204801 | AB (A-rated, therapeutically equivalent) | June 1, 2023 | 12.5MG;20MG, 12.5MG;40MG, 25MG;40MG |
| ALKEM LABORATORIES LTD | 207037 | AB (A-rated, therapeutically equivalent) | July 11, 2024 | 12.5MG;20MG, 12.5MG;40MG, 25MG;40MG |
| HETERO LABS LTD UNIT V | 209199 | AB (A-rated, therapeutically equivalent) | July 25, 2025 | 12.5MG;20MG, 12.5MG;40MG, 25MG;40MG |
| HANGZHOU MINSHENG BINJIANG PHARMACEUTICAL CO LTD | 214427 | AB (A-rated, therapeutically equivalent) | August 20, 2025 | 12.5MG;20MG, 12.5MG;40MG, 25MG;40MG |
| MSN LABORATORIES PRIVATE LTD | 217398 | AB (A-rated, therapeutically equivalent) | September 26, 2025 | 12.5MG;20MG, 12.5MG;40MG, 25MG;40MG |
| SCIEGEN PHARMACEUTICALS INC | 208465 | AB (A-rated, therapeutically equivalent) | March 31, 2026 | 12.5MG;20MG, 12.5MG;40MG, 25MG;40MG |
| MICRO LABS LTD | 206371 | AB (A-rated, therapeutically equivalent) | April 13, 2026 | 12.5MG;20MG, 12.5MG;40MG, 25MG;40MG |
Benicar HCT NDC codes
Questions
Is there a generic for Benicar HCT?
Yes. The generic name for Benicar HCT is olmesartan medoxomil and hydrochlorothiazide. 12 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 Benicar HCT?
The active ingredient in Benicar HCT is olmesartan medoxomil 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.