FDA Orange Book
Generic for Benicar
Benicar contains olmesartan medoxomil. 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 is olmesartan medoxomil. 18 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Benicar products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 20MG | Marketed (Rx) | AB | 18 | AB |
| tablet, oral | 40MG | Marketed (Rx) | AB | 18 | AB |
| tablet, oral | 5MG | Marketed (Rx) | AB | 18 | AB |
NDA 021286, 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
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACCORD HEALTHCARE INC | 207662 | AB (A-rated, therapeutically equivalent) | April 24, 2017 | 20MG, 40MG, 5MG |
| ALEMBIC PHARMACEUTICALS LTD | 203012 | AB (A-rated, therapeutically equivalent) | April 24, 2017 | 20MG, 40MG, 5MG |
| ALKEM LABORATORIES LTD | 206763 | AB (A-rated, therapeutically equivalent) | April 24, 2017 | 20MG, 40MG, 5MG |
| AUROBINDO PHARMA LTD | 204798 | AB (A-rated, therapeutically equivalent) | April 24, 2017 | 20MG, 40MG, 5MG |
| JUBILANT GENERICS LTD | 205482 | AB (A-rated, therapeutically equivalent) | April 24, 2017 | 20MG, 40MG, 5MG |
| MACLEODS PHARMACEUTICALS LTD | 204814 | AB (A-rated, therapeutically equivalent) | April 24, 2017 | 20MG, 40MG, 5MG |
| ZYDUS PHARMACEUTICALS USA INC | 205192 | AB (A-rated, therapeutically equivalent) | April 24, 2017 | 20MG, 40MG, 5MG |
| GLENMARK PHARMACEUTICALS LTD | 203281 | AB (A-rated, therapeutically equivalent) | May 25, 2017 | 20MG, 40MG, 5MG |
| SCIEGEN PHARMACEUTICALS INC | 208130 | AB (A-rated, therapeutically equivalent) | June 29, 2018 | 20MG, 40MG, 5MG |
| QILU PHARMACEUTICAL CO LTD | 210552 | AB (A-rated, therapeutically equivalent) | January 10, 2019 | 20MG, 40MG, 5MG |
| SUNSHINE LAKE PHARMA CO LTD | 211049 | AB (A-rated, therapeutically equivalent) | February 22, 2019 | 20MG, 40MG, 5MG |
| PHARMAZONE | 207135 | AB (A-rated, therapeutically equivalent) | July 18, 2019 | 20MG, 40MG, 5MG |
| ADAPTIS PHARMA PRIVATE LTD | 208659 | AB (A-rated, therapeutically equivalent) | May 18, 2020 | 20MG, 40MG, 5MG |
| PRINSTON PHARMACEUTICAL INC | 206720 | AB (A-rated, therapeutically equivalent) | December 2, 2022 | 20MG, 40MG, 5MG |
| MSN LABORATORIES PRIVATE LTD | 217399 | AB (A-rated, therapeutically equivalent) | January 18, 2023 | 20MG, 40MG, 5MG |
| CHARTWELL RX SCIENCES LLC | 206227 | AB (A-rated, therapeutically equivalent) | January 25, 2024 | 20MG, 40MG, 5MG |
| HETERO LABS LTD UNIT V | 205499 | AB (A-rated, therapeutically equivalent) | October 31, 2024 | 20MG, 40MG, 5MG |
| CADILA PHARMACEUTICALS LTD | 210682 | AB (A-rated, therapeutically equivalent) | November 8, 2024 | 20MG, 40MG, 5MG |
Benicar NDC codes
Questions
Is there a generic for Benicar?
Yes. The generic name for Benicar is olmesartan medoxomil. 18 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?
The active ingredient in Benicar is olmesartan medoxomil, 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.
More on Benicar and Olmesartan Medoxomil
- What is Benicar used for?FDA label uses
- Is Benicar a controlled substance?Federal schedule
- What is Olmesartan Medoxomil used for?FDA label uses
- Is Olmesartan Medoxomil a controlled substance?Federal schedule
- Angiotensin 2 Receptor Blockers listFDA drug class
- NDC 0713-0860Benicar NDC record
- NDC 0713-0861Benicar NDC record
- NDC 0713-0862Benicar NDC record