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NDC 63629-1046-01 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 Bryant Ranch Prepack. 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: 63629-1046-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Naltrexone

Product Information

NDC	63629-1046
Product ID	63629-1046_98bc3962-2a5f-4014-abf8-22e415bbcb21
Associated GPIs	93400030100305
GCN Sequence Number	004518
GCN Sequence Number Description	naltrexone HCl TABLET 50 MG ORAL
HIC3	H3T
HIC3 Description	OPIOID ANTAGONISTS
GCN	17070
HICL Sequence Number	001875
HICL Sequence Number Description	NALTREXONE HCL
Brand/Generic	Generic
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	Bryant Ranch Prepack
Pharmaceutical Class	Opioid Antagonist [EPC], Opioid Antagonists [MoA]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA075274
Listing Certified Through	2024-12-31

Package

NDC 63629-1046-01 (63629104601)

Pricing Information	N/A
NDC Package Code	63629-1046-1
Billing NDC	63629104601
Package	30 TABLET, FILM COATED in 1 BOTTLE (63629-1046-1)
Marketing Start Date	2019-07-01
NDC Exclude Flag	N