nformation
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5997(NDC:0078-0488)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE (AMLODIPINE) AMLODIPINE 5mg
VALSARTAN (VALSARTAN) VALSARTAN 160mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE
HYPROMELLOSES
FERRIC OXIDE YELLOW
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
TALC
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW (dark yellow) Score no score
Shape OVAL (ovaloid shaped) Size 14mm
Flavor Imprint Code NVR;ECE
Contains
Packaging
Item Code Package Description Multilevel Packaging
1 NDC:54868-5997-0 30 TABLET, FILM COATED (30 TABLET) in 1 BOTTLE None
2 NDC:54868-5997-1 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:54868-5804(NDC:0078-0489)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE (AMLODIPINE) AMLODIPINE 10mg
VALSARTAN (VALSARTAN) VALSARTAN 160mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE
HYPROMELLOSES
FERRIC OXIDE YELLOW
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
TALC
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW (light yellow) Score no score
Shape OVAL (ovaloid shaped) Size 14mm
Flavor Imprint Code NVR;UIC
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5804-0 30 TABLET, FILM COATED (30 TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021990 08/15/2007
EXFORGE
amlodipine besylate and valsartan tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5996(NDC:0078-0490)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE (AMLODIPINE) AMLODIPINE 5mg
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 (very dark yellow) Score no score
Shape OVAL (ovaloid shaped) Size 19mm
Flavor Imprint Code NVR;CSF
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5996-0 30 TABLET, FILM COATED (30 TABLET) in 1 BO |
