FDA Orange Book
Generic for Atacand HCT
Atacand HCT contains candesartan cilexetil 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 Atacand HCT is candesartan cilexetil 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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Atacand HCT products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 16MG;12.5MG | Marketed (Rx) | AB | 5 | AB |
| tablet, oral | 32MG;12.5MG | Marketed (Rx) | AB | 4 | AB |
| tablet, oral | 32MG;25MG | Marketed (Rx) | AB | 4 | AB |
NDA 021093, held by ANI PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic candesartan cilexetil and hydrochlorothiazide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PHARMOBEDIENT CONSULTING LLC | 090704 | AB (A-rated, therapeutically equivalent) | December 4, 2012 | 16MG;12.5MG |
| PHARMAZONE | 202965 | AB (A-rated, therapeutically equivalent) | June 3, 2013 | 16MG;12.5MG, 32MG;12.5MG, 32MG;25MG |
| MACLEODS PHARMACEUTICALS LTD | 204100 | AB (A-rated, therapeutically equivalent) | February 27, 2015 | 16MG;12.5MG, 32MG;12.5MG, 32MG;25MG |
| ZYDUS LIFESCIENCES LTD | 203466 | AB (A-rated, therapeutically equivalent) | November 27, 2017 | 16MG;12.5MG, 32MG;12.5MG, 32MG;25MG |
| PRINSTON PHARMACEUTICAL INC | 207455 | AB (A-rated, therapeutically equivalent) | April 11, 2018 | 16MG;12.5MG, 32MG;12.5MG, 32MG;25MG |
Atacand HCT NDC codes
Questions
Is there a generic for Atacand HCT?
Yes. The generic name for Atacand HCT is candesartan cilexetil 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 Atacand HCT?
The active ingredient in Atacand HCT is candesartan cilexetil 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.