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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 075082

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NDA 075082 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 eighteen suppliers. Additional details are available on the METHADONE HYDROCHLORIDE profile page.

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

Summary for 075082

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

Pharmacology for NDA: 075082

Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for 075082

Analgesics, Opioid
Antitussive Agents
Narcotics

Suppliers and Packaging for NDA: 075082

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METHADONE HYDROCHLORIDE	methadone hydrochloride	TABLET, FOR SUSPENSION;ORAL	075082	ANDA	VistaPharm, LLC	66689-898	66689-898-40	100 TABLET in 1 BOTTLE (66689-898-40)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, FOR SUSPENSION;ORAL			Strength	40MG
Approval Date:	Mar 25, 1998	TE:	AA	RLD:	No

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