Naltrexone Hydrochloride (Page 6 of 6)

PRINCIPAL DISPLAY PANEL — 50 mg Tablet Bottle Label

Label 1
(click image for full-size original)
NALTREXONE HYDROCHLORIDE
naltrexone hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-632(NDC:51224-206)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NALTREXONE HYDROCHLORIDE (NALTREXONE) NALTREXONE HYDROCHLORIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSE, UNSPECIFIED
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
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:42291-632-30 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075274 03/26/2015
Labeler — AvKARE (796560394)

Revised: 01/2022 AvKARE

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