NDC Code(s) : 0093-5414-95, 0093-5415-95
Packager : Teva Pharmaceuticals USA Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

FluconazoleFluconazole POWDER, FOR SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-5414
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUCONAZOLE(UNII: 8VZV102JFY)
(FLUCONAZOLE - UNII:8VZV102JFY) 		FLUCONAZOLE10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SUCROSE(UNII: C151H8M554)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
XANTHAN GUM(UNII: TTV12P4NEE)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
.ALPHA.-TOCOPHEROL, DL-(UNII: 7QWA1RIO01)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
Product Characteristics
Color WHITE (white to off-white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0093-5414-9535 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077523 09/22/2008
FluconazoleFluconazole POWDER, FOR SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-5415
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUCONAZOLE(UNII: 8VZV102JFY)
(FLUCONAZOLE - UNII:8VZV102JFY) 		FLUCONAZOLE40 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SUCROSE(UNII: C151H8M554)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
XANTHAN GUM(UNII: TTV12P4NEE)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
.ALPHA.-TOCOPHEROL, DL-(UNII: 7QWA1RIO01)
Product Characteristics
Color WHITE (white to off-white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0093-5415-9535 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077523 09/22/2008

PRINCIPAL DISPLAY PANEL

Fluconazole for Oral Suspension 10mg/mL Label

PRINCIPAL DISPLAY PANEL

Fluconazole for Oral Suspension 40 mg/mL Label