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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 040180

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NDA 040180 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 040180

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

Pharmacology for NDA: 040180

Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for 040180

Analgesics, Opioid
Antitussive Agents
Narcotics

Suppliers and Packaging for NDA: 040180

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METHADONE HYDROCHLORIDE	methadone hydrochloride	CONCENTRATE;ORAL	040180	ANDA	Hikma Pharmaceuticals USA	0054-0392	0054-0392-68	1000 mL in 1 BOTTLE (0054-0392-68)
METHADONE HYDROCHLORIDE	methadone hydrochloride	CONCENTRATE;ORAL	040180	ANDA	ATLANTIC BIOLOGICALS CORP.	17856-0392	17856-0392-1	60 SYRINGE in 1 BOX, UNIT-DOSE (17856-0392-1) / .5 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CONCENTRATE;ORAL			Strength	10MG/ML
Approval Date:	Apr 30, 1998	TE:	AA	RLD:	No

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