Regulatory PathRegulatory requirements compared

Active substances

Oxycodone + Paracetamol

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
OXYCET325MG;5MGtablet · oralSPECGX LLCPrescription7 Dec 1983
PERCOCET325MG;2.5MG; 325MG;5MG; 325MG;7.5MG; 325MG;10MGtablet · oralOZANTRIPrescription25 Jun 1999
OXYCODONE AND ACETAMINOPHEN325MG;7.5MG; 325MG;10MGtablet · oralSPECGX LLCPrescription30 Jun 2004
OXYCODONE AND ACETAMINOPHEN300MG;2.5MG; 300MG;5MG; 300MG;7.5MG; 300MG;10MGtablet · oralPHARMOBEDIENTPrescription30 Dec 2005
OXYCODONE AND ACETAMINOPHEN325MG;5MGtablet · oralAMNEAL PHARMSPrescription27 Nov 2007
OXYCODONE AND ACETAMINOPHEN325MG;10MG; 325MG;7.5MGtablet · oralAMNEAL PHARMS NYPrescription27 Nov 2007
OXYCODONE AND ACETAMINOPHEN325MG;7.5MG; 325MG;10MG; 325MG;5MGtablet · oralALVOGENPrescription26 Jul 2012
OXYCODONE AND ACETAMINOPHEN325MG;2.5MG; 325MG;5MG; 325MG;7.5MG; 325MG;10MGtablet · oralACTAVIS ELIZABETHPrescription12 Apr 2013
OXYCODONE AND ACETAMINOPHEN325MG;2.5MG; 325MG;5MG; 325MG;7.5MG; 325MG;10MGtablet · oralAUROLIFE PHARMA LLCPrescription15 Jul 2013
OXYCODONE AND ACETAMINOPHEN325MG;5MG; 325MG;7.5MG; 325MG;10MGtablet · oralRHODES PHARMSPrescription28 Aug 2014
OXYCODONE AND ACETAMINOPHEN325MG;2.5MG; 325MG;5MG; 325MG;7.5MG; 325MG;10MGtablet · oralNOVEL LABS INCPrescription24 Feb 2017
OXYCODONE AND ACETAMINOPHEN325MG;2.5MG; 325MG;5MG; 325MG;7.5MG; 325MG;10MGtablet · oralASCENT PHARMS INCPrescription22 Mar 2017
OXYCODONE AND ACETAMINOPHEN325MG;5MG; 325MG;10MGtablet · oralLANNETT CO INCPrescription25 Sep 2017
OXYCODONE AND ACETAMINOPHEN325MG;2.5MG; 325MG;5MG; 325MG;7.5MG; 325MG;10MGtablet · oralABHAI LLCPrescription9 Feb 2018
OXYCODONE AND ACETAMINOPHEN325MG;5MG; 325MG;7.5MG; 325MG;10MGtablet · oralWES PHARMA INCPrescription21 Mar 2018
OXYCODONE AND ACETAMINOPHEN325MG;5MG; 325MG;7.5MG; 325MG;10MGtablet · oralEPIC PHARMA LLCPrescription2 Jul 2018
OXYCODONE AND ACETAMINOPHEN325MG;5MG; 325MG;7.5MG; 325MG;10MGtablet · oralELITE LABS INCPrescription2 Jul 2018
OXYCODONE AND ACETAMINOPHEN300MG/5ML;10MG/5MLsolution · oralPHARMOBEDIENTPrescription27 Nov 2018
OXYCODONE AND ACETAMINOPHEN325MG/5ML;5MG/5MLsolution · oralABHAI LLCPrescription31 Dec 2018
OXYCODONE AND ACETAMINOPHEN325MG;2.5MG; 325MG;5MG; 325MG;7.5MG; 325MG;10MGtablet · oralGRANULESPrescription31 Oct 2019
PERCOCET325MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralOZANTRIDiscontinued31 Aug 1976
OXYCODONE 2.5/APAP 500500MG;2.5MGtablet · oralBRISTOL MYERS SQUIBBDiscontinued25 Oct 1977
OXYCODONE 5/APAP 500500MG;5MGtablet · oralBRISTOL MYERS SQUIBBDiscontinued25 Oct 1977
ROXICET325MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralHIKMA PHARMSDiscontinued25 Feb 1980
OXYCODONE AND ACETAMINOPHEN325MG;5MGtablet · oralBARRDiscontinued2 Nov 1981

40 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
APO-OXYCODONE/ACET023246285 MG; 325 MGTABLET · ORALAPOTEX INC
RIVACOCET022424685 MG; 325 MGTABLET · ORALLABORATOIRE RIVA INC.
TEVA-OXYCOCET006081655 MG; 325 MGTABLET · ORALTEVA CANADA LIMITED

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACOXYCODONE-ACETAMINOPHEN 10-325 MG TAB$0.23081per EA23 Sep 2026
US NADACOXYCODONE-ACETAMINOPHEN 10-325 MG TABLET$0.23081per EA23 Sep 2026
US NADACOXYCODONE-ACETAMINOPHEN 2.5-325 MG TABLET$0.76157per EA23 Sep 2026
US NADACOXYCODONE-ACETAMINOPHEN 5-325 MG TAB$0.11705per EA23 Sep 2026
US NADACOXYCODONE-ACETAMINOPHEN 5-325 MG TABLET$0.11705per EA23 Sep 2026
US NADACOXYCODONE-ACETAMINOPHEN 7.5-325 MG TABLET$0.18251per EA23 Sep 2026
US NADACPERCOCET 10-325 MG TABLET$41.39519per EA23 Sep 2026
US NADACPERCOCET 5-325 MG TABLET$29.31652per EA23 Sep 2026
US NADACPERCOCET 7.5-325 MG TABLET$31.60483per EA23 Sep 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Components

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.