NDC Code(s) : 54569-5666-0
Packager : A-S Medication Solutions

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Diovanvalsartan TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54569-5666(NDC:0078-0360)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALSARTAN(UNII: 80M03YXJ7I)
(VALSARTAN - UNII:80M03YXJ7I) 		VALSARTAN320 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE(UNII: 68401960MK)
HYPROMELLOSES(UNII: 3NXW29V3WO)
FERRIC OXIDE RED(UNII: 1K09F3G675)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 8000(UNII: Q662QK8M3B)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Product Characteristics
Color GRAY (dark gray), PURPLE (violet) Score no score
Shape OVAL (almond-shaped with bevelled edges) Size 16 mm
Flavor Imprint Code NVR;DXL
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54569-5666-030 in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021283 07/01/2001

PRINCIPAL DISPLAY PANEL

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