FDA — authorised 31 August 1976
- Application: ANDA085106
- Marketing authorisation holder: OZANTRI
- Local brand name: PERCOCET
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Percocet in United States
FDA authorised Percocet on 31 August 1976 · 93,600 US adverse-event reports
Marketing authorisations
FDA — authorised 25 June 1999
- Application: ANDA040330
- Marketing authorisation holder: OZANTRI
- Local brand name: PERCOCET
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 July 1999
- Application: ANDA040341
- Marketing authorisation holder: VINTAGE PHARMS LLC
- Local brand name: PERCOCET
- 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: 93,600
Most-reported reactions
- Dependence — 18,848 reports (20.14%)
- Death — 16,464 reports (17.59%)
- Overdose — 15,879 reports (16.96%)
- Toxicity To Various Agents — 9,554 reports (10.21%)
- Drug Dependence — 8,793 reports (9.39%)
- Pain — 6,482 reports (6.93%)
- Ill-Defined Disorder — 5,971 reports (6.38%)
- Nausea — 4,309 reports (4.6%)
- Fatigue — 3,661 reports (3.91%)
- Drug Ineffective — 3,639 reports (3.89%)
Percocet in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Percocet approved in United States?
Yes. FDA authorised it on 31 August 1976; FDA authorised it on 25 June 1999; FDA authorised it on 26 July 1999.
Who is the marketing authorisation holder for Percocet in United States?
OZANTRI holds the US marketing authorisation.