Last Updated: November 8, 2026

Details for New Drug Application (NDA): 075082

« Back to Dashboard

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 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 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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.