Exforge HCT®
(amlodipine, valsartan, hydrochlorothiazide)
10 mg* / 320 mg / 25 mg
*each tablet contains 13.9 mg of amlodipine besylate

EXFORGE HCT
amlodipine valsartan and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 54868-6123(0078-0563)
Route of Administration ORAL DEA Schedule 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE(AMLODIPINE) AMLODIPINE 10mg
VALSARTAN(VALSARTAN) VALSARTAN 320mg
HYDROCHLOROTHIAZIDE(HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 25mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE 
CROSPOVIDONE 
HYPROMELLOSE 
FERRIC OXIDE YELLOW 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
TALC 
Product Characteristics
Color brown (brown-yellow)  Score no score
Shape OVAL (ovaloid, biconvex tablets with beveled edge)  Size 19mm
Flavor  Imprint Code NVR;VFL 
Contains 
Packaging
# NDC Package Description Multilevel Packaging
1 54868-6123-0 30TABLETIn1BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022314 05/14/2010 
Labeler -Physicians Total Care, Inc.(194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc.  194123980 relabel