Candesartan cilexetil

Basic Information

Product Name

FDA Product Code

72162-1511

Regulatory Information

NDC Product Code

72162-1511

Application Number

NDA020838

Marketing Category

C73605

Effective Date

August 29, 2023

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use CANDESARTAN CILEXETIL TABLETS safely and effectively. See full prescribing information for CANDESARTAN CILEXETIL TABLETS. CANDESARTAN CILEXETIL tablets, for oral useInitial U.S. Approval: 1998

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

100

Active Ingredients

CANDESARTAN CILEXETIL

Quantity: 8 mg in 1 1

Code: R85M2X0D68

Class Code: ACTIB

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

CARBOXYMETHYLCELLULOSE CALCIUM

Code: UTY7PDF93L

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

POLYETHYLENE GLYCOL 8000

Code: Q662QK8M3B

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIED

Code: 9XZ8H6N6OH

Class Code: IACT

Active Moieties

CANDESARTAN

Code: S8Q36MD2XX

Basic Information

Regulatory Information

Company Information

Active Ingredients

STARCH, CORN

LACTOSE MONOHYDRATE

CARBOXYMETHYLCELLULOSE CALCIUM

FERRIC OXIDE RED

POLYETHYLENE GLYCOL 8000

MAGNESIUM STEARATE

HYDROXYPROPYL CELLULOSE, UNSPECIFIED

Active Moieties

CANDESARTAN