Diovan
These highlights do not include all the information needed to use Diovan safely and effectively. See full prescribing information for Diovan. Diovan (valsartan) Tablets Initial U.S. Approval: 1996
Approved
Approval ID
d73a7aa3-5b5f-4532-9936-752366a2430d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 22, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 3
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 Code21695-919
Application NumberNDA021283
Product Classification
M
Marketing Category
C73594
G
Generic Name
valsartan
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2008
FDA Product Classification
INGREDIENTS (11)
VALSARTANActive
Quantity: 320 mg in 1 1
Code: 80M03YXJ7I
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
valsartan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-918
Application NumberNDA021283
Product Classification
M
Marketing Category
C73594
G
Generic Name
valsartan
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2008
FDA Product Classification
INGREDIENTS (11)
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
VALSARTANActive
Quantity: 160 mg in 1 1
Code: 80M03YXJ7I
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
valsartan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-917
Application NumberNDA021283
Product Classification
M
Marketing Category
C73594
G
Generic Name
valsartan
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2008
FDA Product Classification
INGREDIENTS (10)
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
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
VALSARTANActive
Quantity: 80 mg in 1 1
Code: 80M03YXJ7I
Classification: ACTIB