FDA — authorised 31 May 1960
- Application: NDA011738
- Marketing authorisation holder: ENDO PHARMS
- Local brand name: NUMORPHAN
- Indication: SUPPOSITORY — RECTAL
- Status: approved
🇺🇸 OXYMORPHONE HYDROCHLORIDE in United States
FDA authorised OXYMORPHONE HYDROCHLORIDE on 31 May 1960 · 15,924 US adverse-event reports
Marketing authorisations
FDA — authorised 14 June 2010
- Application: ANDA079087
- Marketing authorisation holder: IMPAX LABS
- Status: supplemented
FDA — authorised 27 September 2010
- Application: ANDA090964
- Marketing authorisation holder: HIKMA
- Local brand name: OXYMORPHONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 December 2010
- Application: ANDA079046
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: OXYMORPHONE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 15 February 2011
- Application: ANDA091443
- Marketing authorisation holder: TEVA
- Local brand name: OXYMORPHONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 January 2013
- Application: ANDA203601
- Marketing authorisation holder: AVANTHI INC
- Local brand name: OXYMORPHONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 April 2013
- Application: ANDA202321
- Marketing authorisation holder: SPECGX LLC
- Local brand name: OXYMORPHONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 July 2013
- Application: ANDA200822
- Marketing authorisation holder: HIKMA
- Local brand name: OXYMORPHONE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 27 June 2014
- Application: ANDA202946
- Marketing authorisation holder: SPECGX LLC
- Local brand name: OXYMORPHONE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 24 October 2014
- Application: ANDA200792
- Marketing authorisation holder: PAR PHARM
- Local brand name: OXYMORPHONE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 15 December 2014
- Application: ANDA201187
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: OXYMORPHONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 April 2016
- Application: ANDA204459
- Marketing authorisation holder: AUROLIFE PHARMA LLC
- Local brand name: OXYMORPHONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 February 2018
- Application: ANDA210175
- Marketing authorisation holder: ASCENT PHARMS INC
- Local brand name: OXYMORPHONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 15,924
Most-reported reactions
- Dependence — 4,902 reports (30.78%)
- Death — 3,323 reports (20.87%)
- Toxicity To Various Agents — 2,787 reports (17.5%)
- Overdose — 2,310 reports (14.51%)
- Drug Dependence — 591 reports (3.71%)
- Drug Abuse — 583 reports (3.66%)
- Back Pain — 432 reports (2.71%)
- Drug Withdrawal Syndrome Neonatal — 350 reports (2.2%)
- Foetal Exposure During Pregnancy — 331 reports (2.08%)
- Pain — 315 reports (1.98%)
OXYMORPHONE HYDROCHLORIDE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is OXYMORPHONE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 31 May 1960; FDA authorised it on 14 June 2010; FDA authorised it on 27 September 2010.
Who is the marketing authorisation holder for OXYMORPHONE HYDROCHLORIDE in United States?
ENDO PHARMS holds the US marketing authorisation.