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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 087393

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NDA 087393 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 087393

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

Pharmacology for NDA: 087393

Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for 087393

Analgesics, Opioid
Antitussive Agents
Narcotics

Suppliers and Packaging for NDA: 087393

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METHADONE HYDROCHLORIDE	methadone hydrochloride	SOLUTION;ORAL	087393	ANDA	Hikma Pharmaceuticals USA Inc.	0054-3555	0054-3555-63	500 mL in 1 BOTTLE (0054-3555-63)
METHADONE HYDROCHLORIDE	methadone hydrochloride	SOLUTION;ORAL	087393	ANDA	ATLANTIC BIOLOGICALS CORP.	17856-3554	17856-3554-1	48 SYRINGE in 1 BOX, UNIT-DOSE (17856-3554-1) / 5 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	5MG/5ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AA	RLD:	Yes

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