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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 207537

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NDA 207537 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 207537

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

Pharmacology for NDA: 207537

Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for 207537

Analgesics, Opioid
Antitussive Agents
Narcotics

Suppliers and Packaging for NDA: 207537

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METHADONE HYDROCHLORIDE	methadone hydrochloride	SOLUTION;ORAL	207537	ANDA	SpecGx LLC	0406-6221	0406-6221-05	500 mL in 1 BOTTLE (0406-6221-05)
METHADONE HYDROCHLORIDE	methadone hydrochloride	SOLUTION;ORAL	207537	ANDA	SpecGx LLC	0406-6225	0406-6225-05	500 mL in 1 BOTTLE (0406-6225-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	5MG/5ML
Approval Date:	Oct 2, 2019	TE:	AA	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	10MG/5ML
Approval Date:	Oct 1, 2019	TE:	AA	RLD:	No

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