Methadone Hydrochloride

Treats opioid addiction (heroin or other morphine-like drugs). Sold as Dolophine Hydrochloride, Methadone Hydrochloride, Westadone, Methadose. Every FDA application for this active ingredient: 6 branded and 28 generic.

As of Nov 15, 2026, FDA lists 34 applications for Methadone Hydrochloride (sold as Dolophine Hydrochloride, Methadone Hydrochloride, Westadone and others), first approved Aug 13, 1947, with 0 new uses approved and 0 published complete response letters.

First approved: Aug 13, 1947
Applications: 34
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $11.5M
First approved in Japan: Sep 28, 2012

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Methadone HCl	Part D	$11.4M	+3%	65,212
Methadone Intensol	Part D	$21K	-11%	201
Methadose	Part D	$14K	+78%	234
Methadone HCL	Part B	$1K	-7%	23
Diskets	Part D	$0K	-15%	0

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

METHADONE 10 MG/ML ORAL CONC: $0.528 per MLGeneric · -2% in a year
METHADONE HCL 10 MG TABLET: $0.182 per unitGeneric · -5% in a year
METHADONE HCL 5 MG TABLET: $0.165 per unitGeneric · -12% in a year

FDA Drug Safety Communications

2 communications since 2020 that name this drug; see all communications

Approvals in Japan (PMDA)

First approved in Japan 781 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Methapain, new ingredientDrugs with a new active ingredient indicated for achieving analgesia of moderate to severe pain associated with various types of cancer which can not be… · Teikoku Seiyaku Co., Ltd. · Sep 28, 2012

Clinical Trials

87 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Methadone Versus Standard of Care for Pain Control in Minimally Invasive Lung Resection SurgeryPain Management · Wake Forest University Health Sciences	Phase 4	Not yet recruiting	Nov 4, 2026
Methadone Administration in Critically Ill Patients in the Intensive Care Unit and Risk of Prolonged QTc and Cardiac ArrythmiaPatients Treated With Methadone · Meir Medical Center	—	Not yet recruiting	Oct 23, 2026
Intraoperative Methadone for the Management of Postoperative Pain in Patients With Head and Neck CancersHead and Neck Carcinoma, Hypopharyngeal Carcinoma · OHSU Knight Cancer Institute	Phase 4	Recruiting	Oct 5, 2026
TRTME: Improving Outpatient Initiation of Medication for Opioid Use Disorder Following HospitalizationOpioid Use Disorder, Opioid Use Disorder, Moderate · T. John Winhusen, PhD	Not applicable	Enrolling by invitation	Aug 21, 2026
Personalized Addiction Treatment enHancementOpioid Use Disorder, mHealth · Rhode Island Hospital	Not applicable	Recruiting	Aug 21, 2026
Subcutaneous Methadone for Cesarean Analgesia: a Non Inferiority Study Using QoR-10Cesarean Section Pain · Clinica Alemana de Santiago	Not applicable	Not yet recruiting	Aug 20, 2026
Deep Transcranial Magnetic Stimulation for Tobacco Cessation in Adults With Opioid Use DisorderOpioid Use Disorder, Tobacco Use Disorder · Payel Roy	Not applicable	Not yet recruiting	Aug 18, 2026
Evaluating the Effectiveness of AIT in the Treatment of Pain Related to Pancreatic CancerPancreatic Cancer Pain, Intrathecal Analgesic · Clinique Bizet	Not applicable	Not yet recruiting	Jul 29, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Aug 13, 1947	Dolophine HydrochlorideNDA 6134	Hikma	31	Discontinued
Aug 13, 1947	Methadone HydrochlorideNDA 21624	Mylan Institutional	8	Marketed
Dec 15, 1947	Methadone HydrochlorideNDA 6383	Mallinckrodt Inc	8	Discontinued
Mar 14, 1973	Methadone HydrochlorideNDA 17058 · New formulation or manufacturer	Hikma	22	Marketed
Mar 14, 1973	WestadoneNDA 17108 · New dosage form	Sandoz	4	Discontinued
Mar 14, 1973	MethadoseNDA 17116 · New dosage form	Specgx LLC	23	Marketed
May 22, 1981	Methadone HydrochlorideANDA 87393	Hikma	41	Marketed
Aug 30, 1982	Methadone HydrochlorideANDA 87997	Hikma	37	Marketed
Mar 8, 1983	Methadone HydrochlorideANDA 88109	Hikma	22	Marketed
Sep 6, 1988	Methadone Hydrochloride IntensolANDA 89897	Hikma	38	Marketed
Apr 15, 1993	MethadoseANDA 40050	Specgx LLC	26	Discontinued
Apr 29, 1993	MethadoseANDA 74184	Specgx LLC	8	Marketed
Nov 30, 1994	Methadone HydrochlorideANDA 40088	Vistapharm LLC	12	Marketed
Apr 28, 1995	Methadone HydrochlorideANDA 74081	Roxane	0	Discontinued
Mar 25, 1998	Methadone HydrochlorideANDA 75082	Vistapharm LLC	10	Marketed
Apr 30, 1998	Methadone HydrochlorideANDA 40180	Hikma	5	Marketed
May 29, 1998	Methadone HydrochlorideANDA 40241	Vistapharm LLC	19	Discontinued
Apr 27, 2004	Methadone HydrochlorideANDA 40517	Specgx LLC	27	Marketed
Jul 12, 2005	Methadone HydrochlorideANDA 77142	Specgx LLC	7	Marketed
Nov 25, 2009	Methadone HydrochlorideANDA 90635	Thepharmanetwork LLC	21	Marketed
Jun 30, 2010	Methadone HydrochlorideANDA 90707	Vistapharm LLC	25	Marketed
Aug 18, 2015	Methadone HydrochlorideANDA 90065	Epic Pharma LLC	14	Marketed
Aug 31, 2015	Methadone HydrochlorideANDA 203502	Aurolife Pharma LLC	13	Marketed
Oct 27, 2017	Methadone HydrochlorideANDA 208306	Long Grove Pharms	0	Marketed
Mar 30, 2018	Methadone HydrochlorideANDA 208305	Sun Pharm Industries	8	Discontinued
Aug 2, 2018	Methadone HydrochlorideANDA 210484	Elite Labs Inc	10	Marketed
Jan 3, 2019	Methadone HydrochlorideANDA 211228	Ascent Pharms Inc	8	Marketed
Aug 22, 2019	Methadone HydrochlorideANDA 207368	Specgx LLC	1	Marketed
Oct 2, 2019	Methadone HydrochlorideANDA 207537	Specgx LLC	9	Marketed
Mar 16, 2020	Methadone HydrochlorideANDA 204166	Vistapharm LLC	7	Marketed
Nov 2, 2020	Methadone HydrochlorideANDA 212093	Lannett Co Inc	4	Marketed
Mar 3, 2021	Methadone HydrochlorideANDA 212094	Lannett Co Inc	0	Discontinued
Dec 16, 2024	Methadone HydrochlorideANDA 218252	Breckenridge	0	Marketed
May 5, 2025	Methadone HydrochlorideANDA 218609	Hikma	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA