NALTREXONE HYDROCHLORIDE (Page 4 of 4)

How Supplied

Naltrexone Hydrochloride Tablets, USP are available as:

50 mg; yellow, round film-coated tablets, bisected on one side, debossed with “EL” on one side of the bisect and “15” on the other side of the bisect. They are available in bottles of:

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Protect from light.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Package Label. Principal Display Panel

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(click image for full-size original)

NALTREXONE HYDROCHLORIDE naltrexone hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76519-1160
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NALTREXONE HYDROCHLORIDE (NALTREXONE) NALTREXONE HYDROCHLORIDE 50 mg
Product Characteristics
Color yellow Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code EL;15
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76519-1160-5 15 TABLET, FILM COATED in 1 CONTAINER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075274 10/17/2017
Labeler — H.J. Harkins Company Inc. (147681894)
Establishment
Name Address ID/FEI Operations
H.J. Harkins Company Inc. 147681894 manufacture (76519-1160), relabel (76519-1160), repack (76519-1160)

Revised: 11/2017 H.J. Harkins Company Inc.

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