Valsartan and Hydrochlorothiazide

Basic Information

Product Name

FDA Product Code

68071-4333

Regulatory Information

NDC Product Code

68071-4333

Application Number

ANDA201662

Marketing Category

C73584

Effective Date

February 16, 2021

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, USP for oral use. Initial U.S. Approval: 1998

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

POLYETHYLENE GLYCOL 400

Code: B697894SGQ

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

VALSARTAN

Quantity: 80 mg in 1 1

Code: 80M03YXJ7I

Class Code: ACTIB

HYDROCHLOROTHIAZIDE

Quantity: 12.5 mg in 1 1

Code: 0J48LPH2TH

Class Code: ACTIB

CROSPOVIDONE

Code: 68401960MK

Class Code: IACT

Active Moieties

HYDROCHLOROTHIAZIDE

Code: 0J48LPH2TH

VALSARTAN

Code: 80M03YXJ7I

Basic Information

Regulatory Information

Company Information

Active Ingredients

CELLULOSE, MICROCRYSTALLINE

SILICON DIOXIDE

MAGNESIUM STEARATE

HYPROMELLOSES

FERRIC OXIDE RED

FERRIC OXIDE YELLOW

POLYETHYLENE GLYCOL 400

TITANIUM DIOXIDE

TALC

CROSPOVIDONE

Active Moieties

HYDROCHLOROTHIAZIDE

VALSARTAN