Last Updated: August 3, 2026

Details for New Drug Application (NDA): 075274

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NDA 075274 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 075274

Tradename:	NALTREXONE HYDROCHLORIDE
Applicant:	Elite Labs
Ingredient:	naltrexone hydrochloride
Patents:	0

Pharmacology for NDA: 075274

Mechanism of Action	Opioid Antagonists

Suppliers and Packaging for NDA: 075274

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NALTREXONE HYDROCHLORIDE	naltrexone hydrochloride	TABLET;ORAL	075274	ANDA	AvKARE	42291-632	42291-632-30	30 TABLET, FILM COATED in 1 BOTTLE (42291-632-30)
NALTREXONE HYDROCHLORIDE	naltrexone hydrochloride	TABLET;ORAL	075274	ANDA	AvKARE	42291-632	42291-632-60	60 TABLET, FILM COATED in 1 BOTTLE (42291-632-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	May 26, 1999	TE:	AB	RLD:	No

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