Fluconazole (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 70934-935-07

Label
(click image for full-size original)
FLUCONAZOLE fluconazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70934-935(NDC:70710-1138)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUCONAZOLE (FLUCONAZOLE) FLUCONAZOLE 100 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
FD&C RED NO. 40
MAGNESIUM STEARATE
POVIDONE K30
Product Characteristics
Color pink (light pink to pink) Score no score
Shape OVAL (modified oval) Size 10mm
Flavor Imprint Code 1138
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70934-935-07 7 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208963 12/16/2021
Labeler — Denton Pharma, Inc. DBA Northwind Pharmaceuticals (080355546)
Registrant — Denton Pharma, Inc. DBA Northwind Pharmaceuticals (080355546)
Establishment
Name Address ID/FEI Operations
Denton Pharma, Inc. DBA Northwind Pharmaceuticals 080355546 repack (70934-935)

Revised: 12/2021 Denton Pharma, Inc. DBA Northwind Pharmaceuticals

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