Exforge HCT
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, hydrochlorothiazide) Tablets Initial U.S. Approval: 2009
Approved
Approval ID
782bcaf4-0aa4-4527-b36f-d350ceb95637
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 19, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
amlodipine valsartan and hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6123
Application NumberNDA022314
Product Classification
M
Marketing Category
C73594
G
Generic Name
amlodipine valsartan and hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 19, 2011
FDA Product Classification
INGREDIENTS (10)
AMLODIPINE BESYLATEActive
Quantity: 10 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
VALSARTANActive
Quantity: 320 mg in 1 1
Code: 80M03YXJ7I
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYDROCHLOROTHIAZIDEActive
Quantity: 25 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT