ATACAND HCT
ATACAND HCT 16-12.5 () TABLETS, FOR ORAL USE ATACAND HCT 32-12.5 () TABLETS, FOR ORAL USE ATACAND HCT 32-25 TABLETS, FOR ORAL USE
Approved
Approval ID
d91152c4-66ba-466f-b4f9-0da628d42b1d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 7, 2020
Manufacturers
FDA
ANI Pharmaceuticals, Inc.
DUNS: 145588013
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Candesartan Cilexetil and Hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62559-650
Application NumberNDA021093
Product Classification
M
Marketing Category
C73594
G
Generic Name
Candesartan Cilexetil and Hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 25, 2019
FDA Product Classification
INGREDIENTS (10)
CANDESARTAN CILEXETILActive
Quantity: 16 mg in 1 1
Code: R85M2X0D68
Classification: ACTIB
HYDROCHLOROTHIAZIDEActive
Quantity: 12.5 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93L
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
Candesartan Cilexetil and Hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62559-652
Application NumberNDA021093
Product Classification
M
Marketing Category
C73594
G
Generic Name
Candesartan Cilexetil and Hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 25, 2019
FDA Product Classification
INGREDIENTS (10)
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CANDESARTAN CILEXETILActive
Quantity: 32 mg in 1 1
Code: R85M2X0D68
Classification: ACTIB
HYDROCHLOROTHIAZIDEActive
Quantity: 25 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93L
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Candesartan Cilexetil and Hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62559-651
Application NumberNDA021093
Product Classification
M
Marketing Category
C73594
G
Generic Name
Candesartan Cilexetil and Hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 25, 2019
FDA Product Classification
INGREDIENTS (9)
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
CANDESARTAN CILEXETILActive
Quantity: 32 mg in 1 1
Code: R85M2X0D68
Classification: ACTIB
HYDROCHLOROTHIAZIDEActive
Quantity: 12.5 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93L
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT