Candesartan

Basic Information

Product Name

Candesartan

FDA Product Code

33342-115

Regulatory Information

NDC Product Code

33342-115

Application Number

ANDA203813

Marketing Category

C73584

Effective Date

December 29, 2022

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 use Initial U.S. Approval: 1998

Labeling Type

Human Prescription Drug Label

Version Number

Active Ingredients

HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED

Code: 2165RE0K14

Class Code: IACT

CANDESARTAN CILEXETIL

Quantity: 8 mg in 1 1

Code: R85M2X0D68

Class Code: ACTIB

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

CARBOXYMETHYLCELLULOSE CALCIUM

Code: UTY7PDF93L

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

Active Moieties

Code: S8Q36MD2XX

Candesartan

Basic Information

Regulatory Information

Company Information

Active Ingredients

HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED

LACTOSE MONOHYDRATE

STARCH, CORN

GLYCERIN

CARBOXYMETHYLCELLULOSE CALCIUM

MAGNESIUM STEARATE

FERRIC OXIDE RED

Active Moieties

CANDESARTAN