FLUCONAZOLE (Page 12 of 12)

PACKAGE LABEL — FLUCONAZOLE 200 MG LABEL

FLUCONAZOLE 200 MG  LABEL Image
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FLUCONAZOLE
fluconazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16590-283(NDC:0172-5413)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUCONAZOLE (FLUCONAZOLE) FLUCONAZOLE 200 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
CROSCARMELLOSE SODIUM
FD&C RED NO. 40
ALUMINUM OXIDE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
TALC
Product Characteristics
Color PINK Score no score
Shape OVAL Size 12mm
Flavor Imprint Code 5413;200
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16590-283-01 01 TABLET in 1 BOTTLE None
2 NDC:16590-283-03 03 TABLET in 1 BOTTLE None
3 NDC:16590-283-30 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076077 07/29/2004
Labeler — STAT Rx USA LLC (786036330)
Registrant — PSS World Medical Inc. (101822682)
Establishment
Name Address ID/FEI Operations
STAT Rx USA LLC 786036330 relabel (16590-283), repack (16590-283)

Revised: 09/2012 STAT Rx USA LLC

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