Naltrexone Hydrochloride (Page 6 of 6)

Storage

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.

naltrexone Hydrochloride

Label ImageLabel Image
NALTREXONE HYDROCHLORIDE
naltrexone hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-3076(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
silicon dioxide
croscarmellose sodium
hypromellose, unspecified
hydroxypropyl cellulose (1600000 WAMW)
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:50090-3076-0 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (50090-3076-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075274 09/23/2013
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-3076)

Revised: 09/2021 A-S Medication Solutions

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