Last Updated: August 3, 2026

Details for New Drug Application (NDA): 074918

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NDA 074918 describes NALTREXONE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Barr, Chartwell, Elite Labs, Novitium Pharma, Specgx Llc, and Sun Pharm, and is included in seven NDAs. It is available from twenty-one suppliers. Additional details are available on the NALTREXONE HYDROCHLORIDE profile page.

The generic ingredient in NALTREXONE HYDROCHLORIDE is naltrexone hydrochloride. There are nineteen drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the naltrexone hydrochloride profile page.

Summary for 074918

Tradename:	NALTREXONE HYDROCHLORIDE
Applicant:	Barr
Ingredient:	naltrexone hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	May 8, 1998	TE:	AB	RLD:	No

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