FDA Orange Book
Generic for Azor
Azor contains amlodipine and 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 Azor is amlodipine and olmesartan medoxomil. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Azor products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 10MG BASE;20MG | Marketed (Rx) | AB | 9 | AB |
| tablet, oral | EQ 10MG BASE;40MG | Marketed (Rx) | AB | 9 | AB |
| tablet, oral | EQ 5MG BASE;20MG | Marketed (Rx) | AB | 9 | AB |
| tablet, oral | EQ 5MG BASE;40MG | Marketed (Rx) | AB | 9 | AB |
NDA 022100, 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 amlodipine and olmesartan medoxomil
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MACLEODS PHARMACEUTICALS LTD | 206884 | AB (A-rated, therapeutically equivalent) | October 26, 2016 | EQ 10MG BASE;20MG, EQ 10MG BASE;40MG, EQ 5MG BASE;20MG, EQ 5MG BASE;40MG |
| AJANTA PHARMA LTD | 207216 | AB (A-rated, therapeutically equivalent) | October 28, 2016 | EQ 10MG BASE;20MG, EQ 10MG BASE;40MG, EQ 5MG BASE;20MG, EQ 5MG BASE;40MG |
| AUROBINDO PHARMA LTD | 206906 | AB (A-rated, therapeutically equivalent) | May 15, 2017 | EQ 10MG BASE;20MG, EQ 10MG BASE;40MG, EQ 5MG BASE;20MG, EQ 5MG BASE;40MG |
| ALEMBIC PHARMACEUTICALS LTD | 207073 | AB (A-rated, therapeutically equivalent) | July 17, 2017 | EQ 10MG BASE;20MG, EQ 10MG BASE;40MG, EQ 5MG BASE;20MG, EQ 5MG BASE;40MG |
| ALKEM LABORATORIES LTD | 209042 | AB (A-rated, therapeutically equivalent) | August 14, 2017 | EQ 10MG BASE;20MG, EQ 10MG BASE;40MG, EQ 5MG BASE;20MG, EQ 5MG BASE;40MG |
| ZYDUS PHARMACEUTICALS USA INC | 207771 | AB (A-rated, therapeutically equivalent) | September 22, 2017 | EQ 10MG BASE;20MG, EQ 10MG BASE;40MG, EQ 5MG BASE;20MG, EQ 5MG BASE;40MG |
| MICRO LABS LTD | 207435 | AB (A-rated, therapeutically equivalent) | November 2, 2017 | EQ 10MG BASE;20MG, EQ 10MG BASE;40MG, EQ 5MG BASE;20MG, EQ 5MG BASE;40MG |
| SCIEGEN PHARMACEUTICALS INC | 209010 | AB (A-rated, therapeutically equivalent) | December 3, 2018 | EQ 10MG BASE;20MG, EQ 10MG BASE;40MG, EQ 5MG BASE;20MG, EQ 5MG BASE;40MG |
| HETERO LABS LTD UNIT V | 209591 | AB (A-rated, therapeutically equivalent) | February 14, 2025 | EQ 10MG BASE;20MG, EQ 10MG BASE;40MG, EQ 5MG BASE;20MG, EQ 5MG BASE;40MG |
Azor NDC codes
Questions
Is there a generic for Azor?
Yes. The generic name for Azor is amlodipine and olmesartan medoxomil. 9 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 Azor?
The active ingredient in Azor is amlodipine and 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.