NDC Code(s) : 54569-5334-0
Packager : A-S Medication Solutions

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

VireadTENOFOVIR DISOPROXIL FUMARATE TABLET, COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54569-5334(NDC:61958-0401)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TENOFOVIR DISOPROXIL FUMARATE(UNII: OTT9J7900I)
(TENOFOVIR ANHYDROUS - UNII:W4HFE001U5) 		TENOFOVIR DISOPROXIL FUMARATE300 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
ALUMINUM OXIDE(UNII: LMI26O6933)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
HYPROMELLOSE 2910 (15000 MPA.S)(UNII: 288VBX44JC)
Product Characteristics
Color BLUE (LIGHT BLUE) Score no score
Shape FREEFORM (Almond-shaped) Size 17 mm
Flavor Imprint Code GILEAD;4331;300
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54569-5334-030 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 NDA021356 10/26/2001

PRINCIPAL DISPLAY PANEL

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