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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 218252

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NDA 218252 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 218252

Tradename:	METHADONE HYDROCHLORIDE
Applicant:	Breckenridge
Ingredient:	methadone hydrochloride
Patents:	0

Pharmacology for NDA: 218252

Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for 218252

Analgesics, Opioid
Antitussive Agents
Narcotics

Suppliers and Packaging for NDA: 218252

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METHADONE HYDROCHLORIDE	methadone hydrochloride	INJECTABLE;INJECTION	218252	ANDA	Breckenridge Pharmaceutical Inc	51991-002	51991-002-98	1 VIAL, GLASS in 1 CARTON (51991-002-98) / 20 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	10MG/ML
Approval Date:	Dec 16, 2024	TE:	AP	RLD:	No

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