Last Updated: November 8, 2026

Details for New Drug Application (NDA): 040088

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NDA 040088 describes METHADONE HYDROCHLORIDE, which is a drug marketed by Hikma, Lannett Co Inc, Specgx Llc, Vistapharm Llc, Breckenridge, Long Grove Pharms, Mylan Institutional, Mallinckrodt Inc, Ascent Pharms Inc, Aurolife Pharma Llc, Elite Labs Inc, Epic Pharma Llc, Roxane, Sun Pharm Industries, and Thepharmanetwork Llc, and is included in twenty-nine NDAs. It is available from nineteen suppliers. Additional details are available on the METHADONE HYDROCHLORIDE profile page.

The generic ingredient in METHADONE HYDROCHLORIDE is methadone hydrochloride. There is one drug master file entry for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the methadone hydrochloride profile page.

Summary for 040088

Tradename:	METHADONE HYDROCHLORIDE
Applicant:	Vistapharm Llc
Ingredient:	methadone hydrochloride
Patents:	0

Pharmacology for NDA: 040088

Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for 040088

Analgesics, Opioid
Antitussive Agents
Narcotics

Suppliers and Packaging for NDA: 040088

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METHADONE HYDROCHLORIDE	methadone hydrochloride	CONCENTRATE;ORAL	040088	ANDA	VistaPharm, LLC	66689-694	66689-694-79	1000 mL in 1 BOTTLE (66689-694-79)
METHADONE HYDROCHLORIDE	methadone hydrochloride	CONCENTRATE;ORAL	040088	ANDA	VistaPharm, LLC	66689-694	66689-694-88	4000 mL in 1 BOTTLE (66689-694-88)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CONCENTRATE;ORAL			Strength	10MG/ML
Approval Date:	Nov 30, 1994	TE:	AA	RLD:	No

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