SILICON DIOXIDE
CROSPOVIDONE
HYPROMELLOSES
FERRIC OXIDE RED
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
TALC
TITANIUM DIOXIDE
Product Characteristics
Color ORANGE (Light orange) Score no score
Shape OVAL (ovaloid) Size 10mm
Flavor Imprint Code CG;HGH
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 0078-0314-06 100BLISTER PACKIn1BOX contains a BLISTER PACK(0078-0314-61)
1 0078-0314-61 1TABLETIn1BLISTER PACK This package is contained within the BOX(0078-0314-06)
2 0078-0314-34 90TABLETIn1BOTTLE None
3 0078-0314-33 14000TABLETIn1BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020818 03/06/1998
DIOVAN HCT
valsartan and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 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
# NDC Package Description Multilevel Packaging
1 0078-0315-06 100BLISTER PACKIn1BOX contains a BLISTER PACK(0078-0315-61)
1 0078-0315-61 1TABLETIn1BLISTER PACK This package is contained within the BOX(0078-0315-06)
2 0078-0315-15 30TABLETIn1BLISTER PACK None
3 0078-0315-34 90TABLETIn1BOTTLE None
4 0078-0315-67 6BLISTER PACKIn1CARTON contains a BLISTER PACK
4 30TABLETIn1BLISTER PACK This package is contained within the CARTON(0078-0315-67)
5 0078-0315-17 7000TABLETIn1BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020818 03/06/1998
DIOVAN HCT
valsartan and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 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
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