Candesartan Cilexetil and Hydrochlorothiazide
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Approved
Approval ID
f3c4f7ed-e667-4528-a675-b032c2a4425d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 15, 2020
Manufacturers
FDA
Mylan Pharmaceuticals Inc.
DUNS: 059295980
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 Code0378-3003
Application NumberANDA090704
Product Classification
M
Marketing Category
C73584
G
Generic Name
candesartan cilexetil and hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 15, 2020
FDA Product Classification
INGREDIENTS (10)
HYDROCHLOROTHIAZIDEActive
Quantity: 25 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
CANDESARTAN CILEXETILActive
Quantity: 32 mg in 1 1
Code: R85M2X0D68
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
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
candesartan cilexetil and hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-3002
Application NumberANDA090704
Product Classification
M
Marketing Category
C73584
G
Generic Name
candesartan cilexetil and hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 15, 2020
FDA Product Classification
INGREDIENTS (9)
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
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
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 Code0378-3001
Application NumberANDA090704
Product Classification
M
Marketing Category
C73584
G
Generic Name
candesartan cilexetil and hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 15, 2020
FDA Product Classification
INGREDIENTS (10)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93L
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
CANDESARTAN CILEXETILActive
Quantity: 16 mg in 1 1
Code: R85M2X0D68
Classification: ACTIB
HYDROCHLOROTHIAZIDEActive
Quantity: 12.5 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB