Last Updated: May 12, 2026

Details for New Drug Application (NDA): 090356

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NDA 090356 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 090356

Tradename:	NALTREXONE HYDROCHLORIDE
Applicant:	Sun Pharm
Ingredient:	naltrexone hydrochloride
Patents:	0

Pharmacology for NDA: 090356

Mechanism of Action	Opioid Antagonists

Suppliers and Packaging for NDA: 090356

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NALTREXONE HYDROCHLORIDE	naltrexone hydrochloride	TABLET;ORAL	090356	ANDA	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8579	0615-8579-39	30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8579-39)
NALTREXONE HYDROCHLORIDE	naltrexone hydrochloride	TABLET;ORAL	090356	ANDA	Major Pharmaceuticals	0904-7036	0904-7036-04	30 BLISTER PACK in 1 CARTON (0904-7036-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Feb 24, 2012	TE:	AB	RLD:	No

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