Oxymorphone Hydrochloride

Sold as Opana, Numorphan, Opana Er. Every FDA application for this active ingredient: 5 branded and 13 generic.

As of Nov 15, 2026, FDA lists 18 applications for Oxymorphone Hydrochloride (sold as Opana, Numorphan, Opana Er), first approved Apr 2, 1959, with 1 new use approved and 0 published complete response letters.

First approved: Apr 2, 1959
Applications: 18
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $20.0M

Medicare Spending

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


Oxymorphone HCl ER	Part D	$19.9M	+3%	2,690
Oxymorphone HCl	Part D	$51K	-87%	138

FDA Drug Safety Communications

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

Orphan Designations (FDA)

One designation, 0 approved for the designated use; see all orphan designations

For relief of severe intractable pain in narcotic-tolerant patients.DuPont Merck Pharmaceutical Company · designated Mar 19, 1985

Clinical Trials

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


Neurophysiological Effects of Medication Tapering During Treatment With Spinal Cord StimulationPersistent Spinal Pain Syndrome Type 2 (PSPS-T2), Lower Spine, Spinal Cord Sensitivity to Neurostimulation · Brai²n	—	Recruiting	Feb 17, 2026
Determining the Effect of Abiraterone on the Metabolism of Oxycodone in Men With Prostate Cancer (the ENABLE Study)Prostate Cancer, Pain Cancer · Deventer Ziekenhuis	Phase 4	Recruiting	Jun 3, 2025
Project 1 Aim 2, Adaptations of the Brain in Chronic Pain With Opioid ExposureOpioid Use, Opioid Dependence · Northwestern University	Phase 2	Active, not recruiting	Jul 19, 2022

Applications

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


Apr 2, 1959	OpanaNDA 11707 · New dosage form	Endo Pharms	19	Discontinued
May 31, 1960	NumorphanNDA 11738 · New dosage form	Endo Pharms	5	Discontinued
Jun 22, 2006	Opana ErNDA 21610 · New dosage form	Endo Operations	23	Discontinued
Jun 22, 2006	OpanaNDA 21611 · New dosage form	Endo Pharms	11	Discontinued
Sep 27, 2010	Oxymorphone HydrochlorideANDA 90964	Hikma	11	Marketed
Dec 21, 2010	Oxymorphone HydrochlorideANDA 79087	Impax Labs	26	Marketed
Feb 15, 2011	Oxymorphone HydrochlorideANDA 91443	Teva	12	Marketed
Dec 9, 2011	Opana ErNDA 201655 · New formulation or manufacturer	Endo Pharms	21	Discontinued
Jan 30, 2013	Oxymorphone HydrochlorideANDA 203601	Avanthi Inc	8	Marketed
Apr 25, 2013	Oxymorphone HydrochlorideANDA 202321	Specgx LLC	3	Discontinued
Jul 11, 2013	Oxymorphone HydrochlorideANDA 79046	Actavis Elizabeth	24	Discontinued
Jul 15, 2013	Oxymorphone HydrochlorideANDA 200822	Hikma	19	Discontinued
Jun 27, 2014	Oxymorphone HydrochlorideANDA 202946	Specgx LLC	11	Discontinued
Oct 24, 2014	Oxymorphone HydrochlorideANDA 200792	Par Pharm	2	Discontinued
Dec 15, 2014	Oxymorphone HydrochlorideANDA 201187	Epic Pharma LLC	11	Marketed
Apr 24, 2015	Oxymorphone HydrochlorideANDA 203506	Sun Pharm Inds Ltd	6	Discontinued
Apr 26, 2016	Oxymorphone HydrochlorideANDA 204459	Aurolife Pharma LLC	12	Marketed
Feb 2, 2018	Oxymorphone HydrochlorideANDA 210175	Ascent Pharms Inc	8	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