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NDC 68094-0909-30 Naltrexone Hydrochloride 50 mg/1 Details

Naltrexone Hydrochloride 50 mg/1

Naltrexone Hydrochloride is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Precision Dose Inc.. The primary component is NALTREXONE HYDROCHLORIDE.

MedlinePlus Drug Summary

Naltrexone is used along with counseling and social support to help people who have stopped drinking alcohol and using street drugs continue to avoid drinking or using drugs. Naltrexone should not be used to treat people who are still using street drugs or drinking large amounts of alcohol. Naltrexone is in a class of medications called opiate antagonists. It works by decreasing the craving for alcohol and blocking the effects of opiate medications and opioid street drugs.

Related Packages: 68094-0909-30
Last Updated: 04/28/2024
MedLinePlus Full Drug Details: Naltrexone

Product Information

NDC	68094-0909
Product ID	68094-909_63c38be3-b7e3-4fd9-8093-f8eaf6745193
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Naltrexone Hydrochloride
Proprietary Name Suffix	n/a
Non-Proprietary Name	Naltrexone Hydrochloride
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	50
Active Ingredient Units	mg/1
Substance Name	NALTREXONE HYDROCHLORIDE
Labeler Name	Precision Dose Inc.
Pharmaceutical Class	Opioid Antagonist [EPC], Opioid Antagonists [MoA]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA075274
Listing Certified Through	2025-12-31

Package

NDC 68094-0909-30 (68094090930)

Pricing Information	N/A
NDC Package Code	68094-909-30
Billing NDC	68094090930
Package	30 TABLET, FILM COATED in 1 BOTTLE (68094-909-30)
Marketing Start Date	2013-09-23
NDC Exclude Flag	N