Fluconazole (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50268-337-15
Fluconazole Tablets USP
100 mg
Rx Only
50 Tablets (5 x 10) Unit Dose
5026833715
NDC 50268-337-15
Fluconazole Tablets USP
100 mg
Rx Only
50 Tablets (5 x 10) Unit Dose
5026833715

Each tablet contains: 100 mg of fluconazole USP.
Usual Dosage: See package insert for full prescribing information.
Dispense in a tight, light-resistant container as described in the USP.

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

AvPAK
A PRODUCT of AvKARE Mfg. Rev. 12/14 AV 09/16 (P)

label 1
(click image for full-size original)

NDC 50268-339-15
Fluconazole Tablets USP
200 mg
Rx Only
50 Tablets (5 x 10) Unit Dose
5026833915
NDC 50268-339-15
Fluconazole Tablets USP
200 mg
Rx Only
50 Tablets (5 x 10) Unit Dose
5026833915

Each tablet contains: 200 mg of fluconazole USP.
Usual Dosage: See package insert for full prescribing information.
Dispense in a tight, light-resistant container as described in the USP.

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

AvPAK
A PRODUCT of AvKARE
Mfg. Rev. 12/14 AV 09/16 (P)

label 2
(click image for full-size original)
FLUCONAZOLE fluconazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-337(NDC:57237-004)
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
CELLULOSE, MICROCRYSTALLINE
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
POVIDONE K30
CROSCARMELLOSE SODIUM
FD&C RED NO. 40
MAGNESIUM STEARATE
Product Characteristics
Color pink (Pink Mottled) Score no score
Shape CAPSULE (Biconvex) Size 10mm
Flavor Imprint Code C;05
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50268-337-15 50 BLISTER PACK in 1 BOX contains a BLISTER PACK (50268-337-11)
1 NDC:50268-337-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX (50268-337-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077731 09/09/2016
FLUCONAZOLE fluconazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-339(NDC:57237-006)
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
CELLULOSE, MICROCRYSTALLINE
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
POVIDONE K30
CROSCARMELLOSE SODIUM
FD&C RED NO. 40
MAGNESIUM STEARATE
Product Characteristics
Color pink (Pink Mottled) Score no score
Shape CAPSULE (Biconvex) Size 14mm
Flavor Imprint Code C;07
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50268-339-15 50 BLISTER PACK in 1 BOX contains a BLISTER PACK (50268-339-11)
1 NDC:50268-339-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX (50268-339-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077731 09/09/2016
Labeler — AvPAK (832926666)

Revised: 01/2022 AvPAK

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