TTLE None
2 NDC:54868-5996-1 90 TABLET, FILM COATED (90 TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021990 03/05/2009
EXFORGE
amlodipine besylate and valsartan tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5983(NDC:0078-0491)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE (AMLODIPINE) AMLODIPINE 10mg
VALSARTAN (VALSARTAN) VALSARTAN 320mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE
HYPROMELLOSES
FERRIC OXIDE YELLOW
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW (dark yellow) Score no score
Shape OVAL (ovaloid shaped) Size 19mm
Flavor Imprint Code NVR;LUF
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5983-0 30 TABLET, FILM COATED (30 TABLET) in 1 BOTTLE None
2 NDC:54868-5983-1 90 TABLET, FILM COATED (90 TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021990 06/22/2009
Labeler -Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel,repack |
