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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 076264

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NDA 076264 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 nineteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the naltrexone hydrochloride profile page.

Summary for 076264

Tradename:	NALTREXONE HYDROCHLORIDE
Applicant:	Specgx Llc
Ingredient:	naltrexone hydrochloride
Patents:	0

Pharmacology for NDA: 076264

Mechanism of Action	Opioid Antagonists

Suppliers and Packaging for NDA: 076264

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NALTREXONE HYDROCHLORIDE	naltrexone hydrochloride	TABLET;ORAL	076264	ANDA	SpecGx LLC	0406-1170	0406-1170-01	100 TABLET, FILM COATED in 1 BOTTLE (0406-1170-01)
NALTREXONE HYDROCHLORIDE	naltrexone hydrochloride	TABLET;ORAL	076264	ANDA	SpecGx LLC	0406-1170	0406-1170-03	30 TABLET, FILM COATED in 1 BOTTLE (0406-1170-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Mar 22, 2002	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Mar 22, 2002	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Mar 22, 2002	TE:		RLD:	No

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