Diovan HCT
These highlights do not include all the information needed to use DIOVAN HCT safely and effectively. See full prescribing information for DIOVAN HCT. DIOVAN HCT (valsartan and hydrochlorothiazide USP) tablets, for oral use Initial U.S. Approval: 1998
Approved
Approval ID
d76a0419-05ee-437e-884c-65807aea9569
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 11, 2023
Manufacturers
FDA
Novartis Pharmaceuticals Corporation
DUNS: 002147023
Products 5
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
valsartan and hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0078-0471
Application NumberNDA020818
Product Classification
M
Marketing Category
C73594
G
Generic Name
valsartan and hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateJune 12, 2019
FDA Product Classification
INGREDIENTS (11)
VALSARTANActive
Quantity: 320 mg in 1 1
Code: 80M03YXJ7I
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYDROCHLOROTHIAZIDEActive
Quantity: 12.5 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
valsartan and hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0078-0314
Application NumberNDA020818
Product Classification
M
Marketing Category
C73594
G
Generic Name
valsartan and hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateJune 12, 2019
FDA Product Classification
INGREDIENTS (11)
VALSARTANActive
Quantity: 80 mg in 1 1
Code: 80M03YXJ7I
Classification: ACTIB
HYDROCHLOROTHIAZIDEActive
Quantity: 12.5 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
valsartan and hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0078-0472
Application NumberNDA020818
Product Classification
M
Marketing Category
C73594
G
Generic Name
valsartan and hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateJune 12, 2019
FDA Product Classification
INGREDIENTS (11)
VALSARTANActive
Quantity: 320 mg in 1 1
Code: 80M03YXJ7I
Classification: ACTIB
HYDROCHLOROTHIAZIDEActive
Quantity: 25 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
valsartan and hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0078-0315
Application NumberNDA020818
Product Classification
M
Marketing Category
C73594
G
Generic Name
valsartan and hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateJune 12, 2019
FDA Product Classification
INGREDIENTS (11)
VALSARTANActive
Quantity: 160 mg in 1 1
Code: 80M03YXJ7I
Classification: ACTIB
HYDROCHLOROTHIAZIDEActive
Quantity: 12.5 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
valsartan and hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0078-0383
Application NumberNDA020818
Product Classification
M
Marketing Category
C73594
G
Generic Name
valsartan and hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateJune 12, 2019
FDA Product Classification
INGREDIENTS (11)
VALSARTANActive
Quantity: 160 mg in 1 1
Code: 80M03YXJ7I
Classification: ACTIB
HYDROCHLOROTHIAZIDEActive
Quantity: 25 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT