AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE

Basic Information

Product Name

FDA Product Code

51407-671

Regulatory Information

NDC Product Code

51407-671

Application Number

ANDA201087

Marketing Category

C73584

Effective Date

September 30, 2022

Territorial Authority

USA

FDA Title

AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE.These highlights do not include all the information needed to use AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE safely and effectively. See full prescribing information for AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE. AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 2009

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

CROSPOVIDONE

Code: 2S7830E561

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

HYDROCHLOROTHIAZIDE

Quantity: 25 mg in 1 1

Code: 0J48LPH2TH

Class Code: ACTIB

POLYSORBATE 20

Code: 7T1F30V5YH

Class Code: IACT

AMLODIPINE BESYLATE

Quantity: 10 mg in 1 1

Code: 864V2Q084H

Class Code: ACTIM

VALSARTAN

Quantity: 160 mg in 1 1

Code: 80M03YXJ7I

Class Code: ACTIB

Active Moieties

HYDROCHLOROTHIAZIDE

Code: 0J48LPH2TH

AMLODIPINE

Code: 1J444QC288

VALSARTAN

Code: 80M03YXJ7I

Basic Information

Regulatory Information

Company Information

Active Ingredients

CROSPOVIDONE

CELLULOSE, MICROCRYSTALLINE

MAGNESIUM STEARATE

D&C YELLOW NO. 10

SILICON DIOXIDE

TITANIUM DIOXIDE

POLYSORBATE 20

Active Moieties

HYDROCHLOROTHIAZIDE

AMLODIPINE

VALSARTAN