Regulatory PathRegulatory requirements compared

Active substance

Oxycodone

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
OXYCONTIN 10 mg controlled release tablet10 mgProlonged-release tablet · Oral use20 BlisterSAR 207.70NCE · PrescriptionPURDUE PHARMA LPValid
OXYCONTIN 15 mg controlled release tablet15 mgProlonged-release tablet · Oral use20 BlisterSAR 297.20NCE · PrescriptionPURDUE PHARMA LPValid
OXYCONTIN 20 mg controlled release tablet20 mgProlonged-release tablet · Oral use20 BlisterSAR 379.70NCE · PrescriptionPURDUE PHARMA LPValid
OXYCONTIN 30 mg controlled release tablet30 mgProlonged-release tablet · Oral use20 BlisterSAR 537.55NCE · PrescriptionPURDUE PHARMA LPValid
OXYCONTIN 40 mg controlled release tablet40 mgProlonged-release tablet · Oral use20 BlisterSAR 673.45NCE · PrescriptionPURDUE PHARMA LPValid
OXYCONTIN 60 mg controlled release tablet60 mgProlonged-release tablet · Oral use20 BlisterSAR 980.55NCE · PrescriptionPURDUE PHARMA LPValid
OXYNORM 10MG CAPSULE10 mgCapsule, hard · Oral use56 BlisterSAR 141.45NCE · PrescriptionNapp pharmaceuticals limited UKValid
OXYNORM 20MG CAPSULE20 mgCapsule, hard · Oral use56 BlisterSAR 270.55NCE · PrescriptionNapp pharmaceuticals limited UKValid
OXYNORM 20MG/2ML AMPOULE10 mg/mlSolution for injection/infusion · Intravenous, Subcutaneous5 AmpouleSAR 65.70NCE · PrescriptionNapp pharmacuticals limited UKValid
OXYNORM 5MG CAPSULE5 mgCapsule, hard · Oral use56 BlisterSAR 70.70NCE · PrescriptionNapp pharmaceuticals limited UKValid
Indications — CHI Daman Drug Formulary

ACUTE PANCREATITIS-PAIN MANAGEMENT; BURN MANAGEMENT; CHRONIC PANCREATITIS; DIABETIC NEUROPATHY; ENDOMETRIOSIS; ENTEROPATHIC ARTHROPATHIES, UNSPECIFIED SITE REACTIVE ARTHROPATHY, UNSPECIFIED; LOW BACK PAIN; NEUROPATHIC PAIN; OSTEOARTHRITIS; PAIN MANAGEMENT IN CANCER PATIENTS; POST-HERPETIC NEURALGIA; POSTOPERATIVE PAIN; RENAL AND URETERIC STONES; SICKLE CELL DISEASE - PAIN MANAGEMENT

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

ProductStrengthForm · routeApplicantStatusFirst approved
ROXICODONE15MG; 30MG; 5MGtablet · oralSPECGX LLCPrescription31 Aug 2000
OXYCODONE HYDROCHLORIDE15MG; 30MG; 5MG; 10MG; 20MGtablet · oralSPECGX LLCPrescription30 Jun 2004
OXYCODONE HYDROCHLORIDE15MG; 30MG; 5MG; 10MG; 20MGtablet · oralSTRIDES PHARMA INTLPrescription31 Jan 2007
OXYCODONE HYDROCHLORIDE5MG; 15MG; 30MGtablet · oralEPIC PHARMA LLCPrescription24 Aug 2009
OXYCODONE HYDROCHLORIDE5MG; 10MG; 15MG; 20MG; 30MGtablet · oralAVANTHI INCPrescription31 Aug 2009
OXYCONTIN10MG; 15MG; 20MG; 30MG; 40MG; 60MG; 80MGtablet, extended release · oralKNOA PHARMAPrescription5 Apr 2010
OXYCODONE HYDROCHLORIDE5MGcapsule · oralGENUS LIFESCIENCESPrescription20 Oct 2010
OXYCODONE HYDROCHLORIDE100MG/5ML; 5MG/5MLsolution · oralGENUS LIFESCIENCESPrescription20 Oct 2010
OXYCODONE HYDROCHLORIDE5MG; 10MG; 15MG; 20MG; 30MGtablet · oralRHODES PHARMSPrescription9 Mar 2011
OXYCODONE HYDROCHLORIDE5MG; 15MG; 30MGtablet · oralALVOGENPrescription30 Dec 2011
OXYCODONE HYDROCHLORIDE5MG; 15MG; 30MGtablet · oralAUROLIFE PHARMA LLCPrescription19 Nov 2012
OXYCODONE HYDROCHLORIDE5MG/5MLsolution · oralHIKMA PHARMSPrescription15 Jul 2013
OXYCODONE HYDROCHLORIDE5MG; 10MG; 15MG; 20MG; 30MGtablet · oralAMNEAL PHARMSPrescription3 Jun 2014
OXYCODONE HYDROCHLORIDE5MG/5MLsolution · oralANI PHARMSPrescription1 Jun 2015
OXYCODONE HYDROCHLORIDE5MGcapsule · oralAVANTHI INCPrescription17 Aug 2015
OXYCODONE HYDROCHLORIDE5MGcapsule · oralNOVEL LABS INCPrescription24 Aug 2015
OXYCODONE HYDROCHLORIDE5MG; 10MG; 15MG; 30MG; 20MGtablet · oralEPIC PHARMA LLCPrescription22 Sep 2015
OXYCODONE HYDROCHLORIDE5MGcapsule · oralANI PHARMSPrescription31 Mar 2016
OXYCODONE HYDROCHLORIDE5MG; 10MG; 15MG; 20MG; 30MGtablet · oralNUVO PHARMPrescription12 Apr 2016
XTAMPZA ER9MG; 13.5MG; 18MG; 27MG; 36MGcapsule, extended release · oralCOLLEGIUM PHARM INCPrescription26 Apr 2016
OXYCODONE HYDROCHLORIDE5MG/5MLsolution · oralADAPTISPrescription23 Nov 2016
ROXYBOND5MG; 15MG; 30MG; 10MGtablet · oralPROTEGA PHARMSPrescription20 Apr 2017
OXYCODONE HYDROCHLORIDE5MG/5ML; 100MG/5MLsolution · oralABHAI LLCPrescription21 Jul 2017
OXYCODONE HYDROCHLORIDE15MG; 30MG; 5MG; 10MG; 20MGtablet · oralASCENT PHARMS INCPrescription7 Aug 2017
OXYCODONE HYDROCHLORIDE100MG/5MLsolution · oralADAPTISPrescription6 Sep 2017

28 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
APO-OXYCODONE CR0230653040 MGTABLET (EXTENDED-RELEASE) · ORALAPOTEX INC
APO-OXYCODONE CR023667465.0 MGTABLET (EXTENDED-RELEASE) · ORALAPOTEX INC
APO-OXYCODONE CR0236675410 MGTABLET (EXTENDED-RELEASE) · ORALAPOTEX INC
APO-OXYCODONE CR0236676220.0 MGTABLET (EXTENDED-RELEASE) · ORALAPOTEX INC
APO-OXYCODONE CR0236678980.0 MGTABLET (EXTENDED-RELEASE) · ORALAPOTEX INC
APO-OXYCODONE CR0239476615 MGTABLET (EXTENDED-RELEASE) · ORALAPOTEX INC
APO-OXYCODONE CR0239477430 MGTABLET (EXTENDED-RELEASE) · ORALAPOTEX INC
APO-OXYCODONE CR0239478260 MGTABLET (EXTENDED-RELEASE) · ORALAPOTEX INC
OXY.IR022319345 MGTABLET · ORALPURDUE PHARMA
OXY.IR0224013110 MGTABLET · ORALPURDUE PHARMA
OXY.IR0224013220 MGTABLET (IMMEDIATE-RELEASE) · ORALPURDUE PHARMA
OXYNEO0237252510 MGTABLET (EXTENDED-RELEASE) · ORALPURDUE PHARMA
OXYNEO0237253315 MGTABLET (EXTENDED-RELEASE) · ORALPURDUE PHARMA
OXYNEO0237254130 MGTABLET (EXTENDED-RELEASE) · ORALPURDUE PHARMA
OXYNEO0237256840 MGTABLET (EXTENDED-RELEASE) · ORALPURDUE PHARMA
OXYNEO0237257660 MGTABLET (EXTENDED-RELEASE) · ORALPURDUE PHARMA
OXYNEO0237258480 MGTABLET (EXTENDED-RELEASE) · ORALPURDUE PHARMA
OXYNEO0237279720 MGTABLET (EXTENDED-RELEASE) · ORALPURDUE PHARMA
PMS-OXYCODONE023199775 MGTABLET · ORALPHARMASCIENCE INC
PMS-OXYCODONE0231998510 MGTABLET · ORALPHARMASCIENCE INC
PMS-OXYCODONE0231999320 MGTABLET · ORALPHARMASCIENCE INC
PMS-OXYCODONE CR0230988210 MGTABLET (EXTENDED-RELEASE) · ORALPHARMASCIENCE INC
PMS-OXYCODONE CR0230989020 MGTABLET (EXTENDED-RELEASE) · ORALPHARMASCIENCE INC
PMS-OXYCODONE CR0230990440 MGTABLET (EXTENDED-RELEASE) · ORALPHARMASCIENCE INC
PMS-OXYCODONE CR0230991280 MGTABLET (EXTENDED-RELEASE) · ORALPHARMASCIENCE INC

3 more — full table

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACOXYCODONE HCL (IR) 10 MG TAB$0.16278per EA23 Sep 2026
US NADACOXYCODONE HCL (IR) 15 MG TAB$0.19655per EA23 Sep 2026
US NADACOXYCODONE HCL (IR) 20 MG TAB$0.24642per EA23 Sep 2026
US NADACOXYCODONE HCL (IR) 30 MG TAB$0.35692per EA23 Sep 2026
US NADACOXYCODONE HCL (IR) 5 MG CAP$0.37462per EA23 Sep 2026
US NADACOXYCODONE HCL (IR) 5 MG TABLET$0.08842per EA23 Sep 2026
US NADACOXYCODONE HCL 100 MG/5 ML CONC$2.19009per ML23 Sep 2026
US NADACOXYCODONE HCL 5 MG/5 ML SOLN$0.07353per ML23 Sep 2026
US NADACOXYCODONE HCL 5 MG/5 ML SOLN$0.04907per ML23 Sep 2026
US NADACOXYCONTIN ER 10 MG TABLET$5.8746per EA23 Sep 2026
US NADACOXYCONTIN ER 15 MG TABLET$8.6604per EA23 Sep 2026
US NADACOXYCONTIN ER 20 MG TABLET$10.95464per EA23 Sep 2026
NHS Drug TariffOxycodone 10mg capsules£22.8656 capsule1 Oct 2026
NHS Drug TariffOxycodone 10mg modified-release tablets£25.0456 tablet1 Oct 2026
NHS Drug TariffOxycodone 10mg tablets£10.2956 tablet1 Oct 2026
NHS Drug TariffOxycodone 10mg/1ml solution for injection ampoules£9.715 ampoule1 Oct 2026
NHS Drug TariffOxycodone 10mg/ml oral solution sugar free£46.63120 ml1 Oct 2026
NHS Drug TariffOxycodone 120mg modified-release tablets£114.3856 tablet1 Oct 2026
NHS Drug TariffOxycodone 15mg modified-release tablets£38.1256 tablet1 Oct 2026
NHS Drug TariffOxycodone 20mg capsules£45.7156 capsule1 Oct 2026
NHS Drug TariffOxycodone 20mg modified-release tablets£50.0856 tablet1 Oct 2026
NHS Drug TariffOxycodone 20mg tablets£20.5756 tablet1 Oct 2026
NHS Drug TariffOxycodone 20mg/2ml solution for injection ampoules£16.005 ampoule1 Oct 2026
NHS Drug TariffOxycodone 30mg modified-release tablets£76.2356 tablet1 Oct 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.

WHO WHO Model List of Essential Medicines (2025)

  • 2.2. Opioid analgesics · core
    Therapeutic equivalent to morphine for Pain

Safety signals and safety-related labeling changes

  • US FDA 22 Dec 2025 OXAYDO — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 22 Dec 2025 OXYCODONE HYDROCHLORIDE — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 22 Dec 2025 OXYCODONE HYDROCHLORIDE — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 22 Dec 2025 OXYCODONE HYDROCHLORIDE — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 22 Dec 2025 OXYCONTIN — safety-related labeling change
    Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 22 Dec 2025 PERCODAN — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 22 Dec 2025 ROXICODONE — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 22 Dec 2025 ROXYBOND — safety-related labeling change
    Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 22 Dec 2025 XTAMPZA ER — safety-related labeling change
    Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 18 Sep 2018 TARGINIQ — safety-related labeling change
    Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 18 Sep 2018 XARTEMIS XR — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 16 Dec 2016 TROXYCA ER — safety-related labeling change
    Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for oxycodone →

Combinations containing Oxycodone

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.