Fluconazole (Page 12 of 12)

PRINCIPAL DISPLAY PANEL — 50 mg Tablet Bottle Label

HARRIS
PHARMACEUTICAL

NDC 67405-601-03

FLUCONAZOLE
TABLETS, USP

50 mg

Meets Dissolution Test 2

30 tablets (pink) Rx only

PRINCIPAL DISPLAY PANEL — 100 mg Tablet Bottle Label

HARRIS
PHARMACEUTICAL

NDC 67405-602-03

FLUCONAZOLE
TABLETS, USP

100 mg

Meets Dissolution Test 2

30 tablets (pink) Rx only

PRINCIPAL DISPLAY PANEL — 200 mg Tablet Bottle Label

HARRIS
PHARMACEUTICAL

NDC 67405-604-03

FLUCONAZOLE
TABLETS, USP

200 mg

Meets Dissolution Test 2

30 tablets (pink) Rx only

PRINCIPAL DISPLAY PANEL — 150 mg Tablet Blister Pack Carton

NDC 67405-603-01

12 Cards x 1 Tablet

HARRIS
PHARMACEUTICAL

FLUCONAZOLE TABLETS, USP

150 mg

Meets Dissolution Test 2

Rx only

FLUCONAZOLE fluconazole tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67405-601 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Fluconazole (Fluconazole) Fluconazole 50 mg

Inactive Ingredients Ingredient Name Strength croscarmellose sodium ANHYDROUS DIBASIC CALCIUM PHOSPHATE FD&C RED NO. 40 ALUMINUM OXIDE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POVIDONE K30

Product Characteristics Color PINK Score no score Shape ROUND (biconvex) Size 7mm Flavor Imprint Code H;01 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:67405-601-03 30 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078423 03/07/2011 07/31/2023

FLUCONAZOLE fluconazole tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67405-602 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 croscarmellose sodium ANHYDROUS DIBASIC CALCIUM PHOSPHATE FD&C RED NO. 40 ALUMINUM OXIDE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POVIDONE K30

Product Characteristics Color PINK Score no score Shape ROUND (biconvex) Size 9mm Flavor Imprint Code H;602 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:67405-602-03 30 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078423 03/07/2011 07/31/2023

FLUCONAZOLE fluconazole tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67405-604 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 croscarmellose sodium ANHYDROUS DIBASIC CALCIUM PHOSPHATE FD&C RED NO. 40 ALUMINUM OXIDE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POVIDONE K30

Product Characteristics Color PINK Score no score Shape ROUND (biconvex) Size 11mm Flavor Imprint Code H;604 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:67405-604-03 30 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078423 03/07/2011 07/31/2023

FLUCONAZOLE fluconazole tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67405-603 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Fluconazole (Fluconazole) Fluconazole 150 mg

Inactive Ingredients Ingredient Name Strength croscarmellose sodium ANHYDROUS DIBASIC CALCIUM PHOSPHATE FD&C RED NO. 40 ALUMINUM OXIDE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POVIDONE K30

Product Characteristics Color PINK Score no score Shape ROUND (biconvex) Size 10mm Flavor Imprint Code H;603 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:67405-603-01 12 BLISTER PACK in 1 CARTON contains a BLISTER PACK 1 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (67405-603-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078423 02/24/2017 07/31/2023

Labeler — Harris Pharmaceutical, Inc. (617204370)

Establishment
Name	Address	ID/FEI	Operations
ANI Pharmaceuticals Canada, Inc.		203858980	MANUFACTURE (67405-601), MANUFACTURE (67405-602), MANUFACTURE (67405-603), MANUFACTURE (67405-604), PACK (67405-601), PACK (67405-602), PACK (67405-603), PACK (67405-604)

Establishment
Name	Address	ID/FEI	Operations
Aphena Pharma Solutions — Tennessee, LLC		128385585	PACK (67405-603)

Revised: 12/2021 Harris Pharmaceutical, Inc.