candesartan cilexetil and hydrochlorothiazide
Candesartan Cilexetil and Hydrochlorothiazide Tablets, 16 mg/12.5 mg, for oral use/Candesartan Cilexetil and Hydrochlorothiazide Tablets, 32 mg/12.5 mg, for oral use/Candesartan Cilexetil and Hydrochlorothiazide Tablets, 32 mg/25 mg, for oral use
Approved
Approval ID
543b9806-ccfa-4144-a2a2-d0e35eaceeee
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 21, 2021
Manufacturers
FDA
Solco Healthcare LLC
DUNS: 828343017
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 Code43547-461
Application NumberANDA207455
Product Classification
M
Marketing Category
C73584
G
Generic Name
candesartan cilexetil and hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateNovember 4, 2020
FDA Product Classification
INGREDIENTS (9)
CANDESARTAN CILEXETILActive
Quantity: 32 mg in 1 1
Code: R85M2X0D68
Classification: ACTIB
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93L
Classification: IACT
HYDROCHLOROTHIAZIDEActive
Quantity: 25 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
HYDROXYPROPYL CELLULOSE (160000 WAMW)Inactive
Code: 0A7M0N7SPE
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
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 Code43547-459
Application NumberANDA207455
Product Classification
M
Marketing Category
C73584
G
Generic Name
candesartan cilexetil and hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateNovember 4, 2020
FDA Product Classification
INGREDIENTS (9)
CANDESARTAN CILEXETILActive
Quantity: 16 mg in 1 1
Code: R85M2X0D68
Classification: ACTIB
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93L
Classification: IACT
HYDROCHLOROTHIAZIDEActive
Quantity: 12.5 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
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 Code43547-460
Application NumberANDA207455
Product Classification
M
Marketing Category
C73584
G
Generic Name
candesartan cilexetil and hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateNovember 4, 2020
FDA Product Classification
INGREDIENTS (10)
CANDESARTAN CILEXETILActive
Quantity: 32 mg in 1 1
Code: R85M2X0D68
Classification: ACTIB
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93L
Classification: IACT
HYDROCHLOROTHIAZIDEActive
Quantity: 12.5 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT