NDC Code(s) : 42291-257-90
Packager : AvKARE, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DutasterideDutasteride CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-257(NDC:65162-750)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DUTASTERIDE(UNII: O0J6XJN02I)
(DUTASTERIDE - UNII:O0J6XJN02I) 		DUTASTERIDE0.5 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN(UNII: 2G86QN327L)
GLYCERIN(UNII: PDC6A3C0OX)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
WATER(UNII: 059QF0KO0R)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
GLYCERYL CAPRYLATE/CAPRATE(UNII: G7515SW10N)
Product Characteristics
Color yellow (opaque) Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code A;75
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42291-257-9090 in 1 BOTTLE Type 0: Not a Combination Product30/11/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203118 11/30/2015

PRINCIPAL DISPLAY PANEL

AvKARE

NDC 42291-257-90

Dutasteride Capsules

0.5 mg

WARNING: Dutasteride Capsules should not be used by women or children. Women who are or may potentially be pregnant should not use or handle Dutasteride Capsules (see prescribing information). If contact is made with leaking capsule, wash immediately with soap and water.

90 Capsules        Rx Only

Pharmacist: Please Dispense with Patient Information Leaflet Provided Separately to Each patient.

Each soft gelatin capsule contains 0.5 mg of dutasteride, USP

Usual Adult Dosage: 0.5 mg once a day. Capsules should be swallowed show and not chewed or opened. See
prescribing information for further dosing information.

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

Dispense in a tight, light-resistant container as defined in the USP.

Do not use if seal under bottle cap is broken or missing.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

Mfg. Rev. 10-2015-01         AV 11/15 (P)

N3   42291 25790   0

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