FDA Orange Book
Generic for Tribenzor
Tribenzor contains olmesartan medoxomil, amlodipine 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 Tribenzor is olmesartan medoxomil, amlodipine and hydrochlorothiazide. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Tribenzor products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 10MG BASE;12.5MG;40MG | Marketed (Rx) | AB | 7 | AB |
| tablet, oral | EQ 10MG BASE;25MG;40MG | Marketed (Rx) | AB | 7 | AB |
| tablet, oral | EQ 5MG BASE;12.5MG;20MG | Marketed (Rx) | AB | 7 | AB |
| tablet, oral | EQ 5MG BASE;12.5MG;40MG | Marketed (Rx) | AB | 7 | AB |
| tablet, oral | EQ 5MG BASE;25MG;40MG | Marketed (Rx) | AB | 7 | AB |
NDA 200175, 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, amlodipine and hydrochlorothiazide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PH HEALTH LTD | 206137 | AB (A-rated, therapeutically equivalent) | October 26, 2016 | EQ 10MG BASE;12.5MG;40MG, EQ 10MG BASE;25MG;40MG, EQ 5MG BASE;12.5MG;20MG, EQ 5MG BASE;12.5MG;40MG, EQ 5MG BASE;25MG;40MG |
| TORRENT PHARMACEUTICALS LTD | 203580 | AB (A-rated, therapeutically equivalent) | October 26, 2016 | EQ 10MG BASE;12.5MG;40MG, EQ 10MG BASE;25MG;40MG, EQ 5MG BASE;12.5MG;20MG, EQ 5MG BASE;12.5MG;40MG, EQ 5MG BASE;25MG;40MG |
| TEVA PHARMACEUTICALS USA | 202491 | AB (A-rated, therapeutically equivalent) | November 3, 2016 | EQ 10MG BASE;12.5MG;40MG, EQ 10MG BASE;25MG;40MG, EQ 5MG BASE;12.5MG;20MG, EQ 5MG BASE;12.5MG;40MG, EQ 5MG BASE;25MG;40MG |
| PIRAMAL HEALTHCARE UK LTD | 210718 | AB (A-rated, therapeutically equivalent) | May 14, 2025 | EQ 10MG BASE;12.5MG;40MG, EQ 10MG BASE;25MG;40MG, EQ 5MG BASE;12.5MG;20MG, EQ 5MG BASE;12.5MG;40MG, EQ 5MG BASE;25MG;40MG |
| MACLEODS PHARMACEUTICALS LTD | 207088 | AB (A-rated, therapeutically equivalent) | July 18, 2025 | EQ 10MG BASE;12.5MG;40MG, EQ 10MG BASE;25MG;40MG, EQ 5MG BASE;12.5MG;20MG, EQ 5MG BASE;12.5MG;40MG, EQ 5MG BASE;25MG;40MG |
| HETERO LABS LTD UNIT V | 209242 | AB (A-rated, therapeutically equivalent) | October 6, 2025 | EQ 10MG BASE;12.5MG;40MG, EQ 10MG BASE;25MG;40MG, EQ 5MG BASE;12.5MG;20MG, EQ 5MG BASE;12.5MG;40MG, EQ 5MG BASE;25MG;40MG |
| MICRO LABS LTD | 207437 | AB (A-rated, therapeutically equivalent) | November 24, 2025 | EQ 10MG BASE;12.5MG;40MG, EQ 10MG BASE;25MG;40MG, EQ 5MG BASE;12.5MG;20MG, EQ 5MG BASE;12.5MG;40MG, EQ 5MG BASE;25MG;40MG |
Tribenzor NDC codes
Questions
Is there a generic for Tribenzor?
Yes. The generic name for Tribenzor is olmesartan medoxomil, amlodipine and hydrochlorothiazide. 7 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 Tribenzor?
The active ingredient in Tribenzor is olmesartan medoxomil, amlodipine 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.