kage Description Multilevel Packaging
1 NDC:54868-4425-0 30 TABLET, FILM COATED (90 TABLET) in 1 BOTTLE None
2 NDC:54868-4425-3 90 TABLET, FILM COATED (14000 TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020818 06/22/2009
DIOVAN HCT
valsartan and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4428(NDC:0078-0315)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5mg
VALSARTAN (VALSARTAN) VALSARTAN 160mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE
HYPROMELLOSES
FERRIC OXIDE RED
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
TALC
TITANIUM DIOXIDE
HYPROMELLOSES
Product Characteristics
Color RED (Dark red) Score no score
Shape OVAL Size 15mm
Flavor Imprint Code CG;HHH
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-4428-0 30 TABLET, FILM COATED (90 TABLET) in 1 BOTTLE None
2 NDC:54868-4428-2 60 TABLET, FILM COATED (7000 TABLET) in 1 BOTTLE None
3 NDC:54868-4428-3 90 TABLET, FILM COATED ( TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020818 06/22/2009
DIOVAN HCT
valsartan and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5323(NDC:0078-0383)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 25mg
VALSARTAN (VALSARTAN) VALSARTAN 160mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE
HYPROMELLOSES
FERRIC OXIDE RED
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
TALC
TITANIUM DIOXIDE
Product Characteristics
Color BROWN (Brown orange) Score no score
Shape OVAL Size 14mm
Flavor Imprint Code NVR;HXH
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5323-0 30 TABLET, FILM COATED (30 TABLET) in 1 BOTTLE None
2 NDC:54868-5323-1 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 NDA020818 11/25/2008
DIOVAN HCT
valsartan and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5780(NDC:0078-0471)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROT |
