FDA Orange Book
Generic for Micardis HCT
Micardis HCT contains telmisartan 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 Micardis HCT is telmisartan and hydrochlorothiazide. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Micardis HCT products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 12.5MG;40MG | Marketed (Rx) | AB | 5 | AB |
| tablet, oral | 12.5MG;80MG | Marketed (Rx) | AB | 5 | AB |
| tablet, oral | 25MG;80MG | Marketed (Rx) | AB | 5 | AB |
NDA 021162, held by BOEHRINGER INGELHEIM. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic telmisartan and hydrochlorothiazide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ALEMBIC PHARMACEUTICALS LTD | 203010 | AB (A-rated, therapeutically equivalent) | February 25, 2014 | 12.5MG;40MG, 12.5MG;80MG, 25MG;80MG |
| AUROBINDO PHARMA LTD | 208727 | AB (A-rated, therapeutically equivalent) | December 15, 2016 | 12.5MG;40MG, 12.5MG;80MG, 25MG;80MG |
| ZYDUS PHARMACEUTICALS USA INC | 204221 | AB (A-rated, therapeutically equivalent) | August 15, 2017 | 12.5MG;40MG, 12.5MG;80MG, 25MG;80MG |
| PRINSTON PHARMACEUTICAL INC | 209028 | AB (A-rated, therapeutically equivalent) | November 6, 2017 | 12.5MG;40MG, 12.5MG;80MG, 25MG;80MG |
| GLENMARK PHARMACEUTICALS LTD | 202544 | AB (A-rated, therapeutically equivalent) | March 4, 2019 | 12.5MG;40MG, 12.5MG;80MG, 25MG;80MG |
Micardis HCT NDC codes
Questions
Is there a generic for Micardis HCT?
Yes. The generic name for Micardis HCT is telmisartan and hydrochlorothiazide. 5 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 Micardis HCT?
The active ingredient in Micardis HCT is telmisartan 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.