Exforge HCT

Basic Information

Product Name

Exforge HCT

FDA Product Code

0078-0563

Regulatory Information

NDC Product Code

0078-0563

Application Number

NDA022314

Marketing Category

C73594

Effective Date

June 12, 2019

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use EXFORGE HCT safely and effectively. See full prescribing information for EXFORGE HCT. EXFORGE HCT (amlodipine, valsartan, and hydrochlorothiazide) tablets, for oral use Initial U.S. Approval: 2009

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

VALSARTAN

Quantity: 320 mg in 1 1

Code: 80M03YXJ7I

Class Code: ACTIB

AMLODIPINE BESYLATE

Quantity: 10 mg in 1 1

Code: 864V2Q084H

Class Code: ACTIM

CROSPOVIDONE

Code: 68401960MK

Class Code: IACT

HYDROCHLOROTHIAZIDE

Quantity: 25 mg in 1 1

Code: 0J48LPH2TH

Class Code: ACTIB

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

Active Moieties

VALSARTAN

Code: 80M03YXJ7I

AMLODIPINE

Code: 1J444QC288

HYDROCHLOROTHIAZIDE

Code: 0J48LPH2TH

Basic Information

Regulatory Information

Company Information

Active Ingredients

CROSPOVIDONE

SILICON DIOXIDE

FERRIC OXIDE YELLOW

MAGNESIUM STEARATE

HYPROMELLOSES

TALC

CELLULOSE, MICROCRYSTALLINE

Active Moieties

VALSARTAN

AMLODIPINE

HYDROCHLOROTHIAZIDE