NDC Code(s) : 54569-3954-0
Packager : A-S Medication Solutions

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Diflucanfluconazole TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54569-3954(NDC:0049-3500)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUCONAZOLE(UNII: 8VZV102JFY)
(FLUCONAZOLE - UNII:8VZV102JFY) 		FLUCONAZOLE150 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS(UNII: L11K75P92J)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FD&C RED NO. 40(UNII: WZB9127XOA)
ALUMINUM OXIDE(UNII: LMI26O6933)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POVIDONES(UNII: FZ989GH94E)
Product Characteristics
Color PINK Score no score
Shape OVAL Size 12 mm
Flavor Imprint Code DIFLUCAN;150;ROERIG
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54569-3954-01 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 NDA019949 01/29/1990

PRINCIPAL DISPLAY PANEL

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