Valsartan
Valsartan Tablets, USP Rx Only These highlights do not include all the information needed to use VALSARTAN TABLETS safely and effectively. See full prescribing information for VALSARTAN TABLETS. Initial U.S. Approval: 1996
Approved
Approval ID
0878f27e-5368-c93f-e063-6394a90a1086
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 24, 2023
Manufacturers
FDA
AvPAK
DUNS: 832926666
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Valsartan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50268-746
Application NumberANDA203311
Product Classification
M
Marketing Category
C73584
G
Generic Name
Valsartan
Product Specifications
Route of AdministrationORAL
Effective DateOctober 24, 2023
FDA Product Classification
INGREDIENTS (10)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
VALSARTANActive
Quantity: 40 mg in 1 1
Code: 80M03YXJ7I
Classification: ACTIB
Valsartan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50268-747
Application NumberANDA203311
Product Classification
M
Marketing Category
C73584
G
Generic Name
Valsartan
Product Specifications
Route of AdministrationORAL
Effective DateOctober 24, 2023
FDA Product Classification
INGREDIENTS (10)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
VALSARTANActive
Quantity: 80 mg in 1 1
Code: 80M03YXJ7I
Classification: ACTIB
Valsartan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50268-749
Application NumberANDA203311
Product Classification
M
Marketing Category
C73584
G
Generic Name
Valsartan
Product Specifications
Route of AdministrationORAL
Effective DateOctober 24, 2023
FDA Product Classification
INGREDIENTS (12)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
VALSARTANActive
Quantity: 320 mg in 1 1
Code: 80M03YXJ7I
Classification: ACTIB
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
Valsartan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50268-748
Application NumberANDA203311
Product Classification
M
Marketing Category
C73584
G
Generic Name
Valsartan
Product Specifications
Route of AdministrationORAL
Effective DateOctober 24, 2023
FDA Product Classification
INGREDIENTS (11)
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
VALSARTANActive
Quantity: 160 mg in 1 1
Code: 80M03YXJ7I
Classification: ACTIB