Valsartan and Hydrochlorothiazide

Basic Information

Product Name

FDA Product Code

53002-2787

Regulatory Information

NDC Product Code

53002-2787

Application Number

ANDA203145

Marketing Category

C73584

Effective Date

November 2, 2022

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use VALSARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for VALSARTAN and HYDROCHLOROTHIAZIDE TABLETS. VALSARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1998

Labeling Type

Human Prescription Drug Label

Version Number

Active Ingredients

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

VALSARTAN

Quantity: 320 mg in 1 1

Code: 80M03YXJ7I

Class Code: ACTIB

HYDROCHLOROTHIAZIDE

Quantity: 12.5 mg in 1 1

Code: 0J48LPH2TH

Class Code: ACTIB

CROSPOVIDONE (15 MPA.S AT 5%)

Code: 68401960MK

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

Active Moieties

VALSARTAN

Code: 80M03YXJ7I

HYDROCHLOROTHIAZIDE

Code: 0J48LPH2TH

Basic Information

Regulatory Information

Company Information

Active Ingredients

FERRIC OXIDE RED

CROSPOVIDONE (15 MPA.S AT 5%)

MAGNESIUM STEARATE

MICROCRYSTALLINE CELLULOSE

TALC

TITANIUM DIOXIDE

POLYETHYLENE GLYCOL, UNSPECIFIED

HYPROMELLOSE, UNSPECIFIED

FERROSOFERRIC OXIDE

SILICON DIOXIDE

Active Moieties

VALSARTAN

HYDROCHLOROTHIAZIDE