CANDESARTAN CILEXETIL
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
Approved
Approval ID
d5b43fa0-6678-4219-99f1-10d273d49baf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 27, 2023
Manufacturers
FDA
Alembic Pharmaceuticals Limited
DUNS: 650574663
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
CANDESARTAN CILEXETIL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code46708-342
Application NumberANDA210302
Product Classification
M
Marketing Category
C73584
G
Generic Name
CANDESARTAN CILEXETIL
Product Specifications
Route of AdministrationORAL
Effective DateOctober 9, 2019
FDA Product Classification
INGREDIENTS (8)
CANDESARTAN CILEXETILActive
Quantity: 8 mg in 1 1
Code: R85M2X0D68
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)Inactive
Code: 5Y0974F5PW
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93L
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CANDESARTAN CILEXETIL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code46708-343
Application NumberANDA210302
Product Classification
M
Marketing Category
C73584
G
Generic Name
CANDESARTAN CILEXETIL
Product Specifications
Route of AdministrationORAL
Effective DateOctober 9, 2019
FDA Product Classification
INGREDIENTS (8)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CANDESARTAN CILEXETILActive
Quantity: 16 mg in 1 1
Code: R85M2X0D68
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)Inactive
Code: 5Y0974F5PW
Classification: IACT
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CANDESARTAN CILEXETIL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code46708-341
Application NumberANDA210302
Product Classification
M
Marketing Category
C73584
G
Generic Name
CANDESARTAN CILEXETIL
Product Specifications
Route of AdministrationORAL
Effective DateOctober 9, 2019
FDA Product Classification
INGREDIENTS (7)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CANDESARTAN CILEXETILActive
Quantity: 4 mg in 1 1
Code: R85M2X0D68
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)Inactive
Code: 5Y0974F5PW
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT