Candesartan cilexetil
CANDESARTAN CILEXETIL TABLETS
Approved
Approval ID
26df3269-3682-4ce0-be81-8c029254b5a8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 13, 2022
Manufacturers
FDA
Zydus Lifesciences Limited
DUNS: 918596198
Products 4
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 Code70771-1205
Application NumberANDA091390
Product Classification
M
Marketing Category
C73584
G
Generic Name
Candesartan cilexetil
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2022
FDA Product Classification
INGREDIENTS (8)
CANDESARTAN CILEXETILActive
Quantity: 8 mg in 1 1
Code: R85M2X0D68
Classification: ACTIB
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93L
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)Inactive
Code: 5Y0974F5PW
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
Candesartan cilexetil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1206
Application NumberANDA091390
Product Classification
M
Marketing Category
C73584
G
Generic Name
Candesartan cilexetil
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2022
FDA Product Classification
INGREDIENTS (7)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CANDESARTAN CILEXETILActive
Quantity: 16 mg in 1 1
Code: R85M2X0D68
Classification: ACTIB
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)Inactive
Code: 5Y0974F5PW
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
Candesartan cilexetil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1204
Application NumberANDA091390
Product Classification
M
Marketing Category
C73584
G
Generic Name
Candesartan cilexetil
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2022
FDA Product Classification
INGREDIENTS (8)
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93L
Classification: IACT
CANDESARTAN CILEXETILActive
Quantity: 4 mg in 1 1
Code: R85M2X0D68
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)Inactive
Code: 5Y0974F5PW
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Candesartan cilexetil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1207
Application NumberANDA091390
Product Classification
M
Marketing Category
C73584
G
Generic Name
Candesartan cilexetil
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2022
FDA Product Classification
INGREDIENTS (7)
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93L
Classification: IACT
CANDESARTAN CILEXETILActive
Quantity: 32 mg in 1 1
Code: R85M2X0D68
Classification: ACTIB
HYDROXYPROPYL CELLULOSE (110000 WAMW)Inactive
Code: 5Y0974F5PW
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT