HIAZIDE 12.5mg
VALSARTAN (VALSARTAN) VALSARTAN 320mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
TALC
TITANIUM DIOXIDE
FERRIC OXIDE RED
Product Characteristics
Color PINK Score no score
Shape OVAL Size 18mm
Flavor Imprint Code NVR;HIL
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5780-0 30 TABLET, FILM COATED (30 TABLET) in 1 BOTTLE None
2 NDC:54868-5780-1 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 06/15/2007
DIOVAN HCT
valsartan and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5607(NDC:0078-0472)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 25mg
VALSARTAN (VALSARTAN) VALSARTAN 320mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE
HYPROMELLOSES
FERRIC OXIDE RED
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
TALC
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW (Yellow) Score no score
Shape OVAL Size 18mm
Flavor Imprint Code NVR;CTI
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5607-0 30 TABLET, FILM COATED (30 TABLET) in 1 BOTTLE None
2 NDC:54868-5607-1 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 12/04/2008
Labeler -Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel,repack
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