FDA Orange Book
Generic for Atacand
Atacand contains candesartan cilexetil. 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 is candesartan cilexetil. 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 products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 16MG | Marketed (Rx) | AB | 5 | AB |
| tablet, oral | 32MG | Marketed (Rx) | AB | 5 | AB |
| tablet, oral | 4MG | Marketed (Rx) | AB | 4 | AB |
| tablet, oral | 8MG | Marketed (Rx) | AB | 5 | AB |
NDA 020838, 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
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MYLAN PHARMACEUTICALS INC | 078702 | AB (A-rated, therapeutically equivalent) | May 3, 2013 | 16MG, 32MG, 4MG, 8MG |
| MACLEODS PHARMACEUTICALS LTD | 203813 | AB (A-rated, therapeutically equivalent) | December 5, 2016 | 16MG, 32MG, 4MG, 8MG |
| ALEMBIC PHARMACEUTICALS LTD | 209119 | AB (A-rated, therapeutically equivalent) | June 20, 2017 | 32MG |
| ZYDUS LIFESCIENCES LTD | 091390 | AB (A-rated, therapeutically equivalent) | August 23, 2017 | 16MG, 32MG, 4MG, 8MG |
| ALEMBIC PHARMACEUTICALS LTD | 210302 | AB (A-rated, therapeutically equivalent) | December 4, 2018 | 16MG, 4MG, 8MG |
| PRINSTON PHARMACEUTICAL INC | 206233 | AB (A-rated, therapeutically equivalent) | August 21, 2023 | 16MG, 32MG, 8MG |
Atacand NDC codes
Questions
Is there a generic for Atacand?
Yes. The generic name for Atacand is candesartan cilexetil. 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?
The active ingredient in Atacand is candesartan cilexetil, 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.