Valsartan

Basic Information

Product Name

Valsartan

FDA Product Code

71335-2248

Regulatory Information

NDC Product Code

71335-2248

Application Number

ANDA204821

Marketing Category

C73584

Effective Date

September 12, 2021

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use VALSARTAN TABLETS safely and effectively. See full prescribing information for VALSARTAN TABLETS. VALSARTAN tablets, for ORAL useInitial U.S. Approval: 1996

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

100

Active Ingredients

VALSARTAN

Quantity: 160 mg in 1 1

Code: 80M03YXJ7I

Class Code: ACTIB

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

POLYETHYLENE GLYCOL 3350

Code: G2M7P15E5P

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

POLYVINYL ALCOHOL, UNSPECIFIED

Code: 532B59J990

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

CROSPOVIDONE (120 .MU.M)

Code: 68401960MK

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

Active Moieties

Code: 80M03YXJ7I

Valsartan

Basic Information

Regulatory Information

Company Information

Active Ingredients

TITANIUM DIOXIDE

POLYETHYLENE GLYCOL 3350

MAGNESIUM STEARATE

TALC

POLYVINYL ALCOHOL, UNSPECIFIED

FERRIC OXIDE YELLOW

MICROCRYSTALLINE CELLULOSE

CROSPOVIDONE (120 .MU.M)

SILICON DIOXIDE

Active Moieties

VALSARTAN