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Naloxone (Xonocod Xr, Codep Xr)

Naloxone

Austell Pharmaceuticals (Pty) Ltd

Registration

Applicant
Austell Pharmaceuticals (Pty) Ltd
Registrations
10

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Xonocod xr 5/2,5 MG

EACH TABLET CONTAINS OXYCODONE HYDROCHLORIDE EQUIVALENT TO OXYCODONE 5,0 mg NALOXONE HYDROCHLORIDE DIHYDRATE EQUIVALENT TO NALOXONE 2,5 mg

5/2,5 mg53074553/2.9/0745RegistreredNot determinedNone
Xonocod xr 10/5 MG

EACH TABLET CONTAINS OXYCODONE HYDROCHLORIDE EQUIVALENT TO OXYCODONE 10,0 mg NALOXONE HYDROCHLORIDE DIHYDRATE EQUIVALENT TO NALOXONE 5,0 mg

10/5 mg53074653/2.9/0746RegistreredNot determinedNone
Xonocod xr 20/10 MG

EACH TABLET CONTAINS OXYCODONE HYDROCHLORIDE EQUIVALENT TO OXYCODONE 20,0 mg NALOXONE HYDROCHLORIDE DIHYDRATE EQUIVALENT TO NALOXONE 10,0 mg

20/10 mg53074753/2.9/0747RegistreredNot determinedNone
Xonocod xr 30/15 MG

EACH TABLET CONTAINS OXYCODONE HYDROCHLORIDE EQUIVALENT TO OXYCODONE 30,0 mg NALOXONE HYDROCHLORIDE DIHYDRATE EQUIVALENT TO NALOXONE 15,0 mg

30/15 mg53074853/2.9/0748RegistreredNot determinedNone
Xonocod xr 40/20 MG

EACH TABLET CONTAINS OXYCODONE HYDROCHLORIDE EQUIVALENT TO OXYCODONE 40,0 mg NALOXONE HYDROCHLORIDE DIHYDRATE EQUIVALENT TO NALOXONE 20,0 mg

40/20 mg53074953/2.9/0749RegistreredNot determinedNone
Codep xr 5/2,5 MG

EACH TABLET CONTAINS OXYCODONE HYDROCHLORIDE EQUIVALENT TO OXYCODONE 5,0 mg NALOXONE HYDROCHLORIDE DIHYDRATE EQUIVALENT TO NALOXONE 2,5 mg

5/2,5 mg530750.74553/2.9/0750.745RegistreredNot determinedNone
Codep xr 10/5 MG

EACH TABLET CONTAINS OXYCODONE HYDROCHLORIDE EQUIVALENT TO OXYCODONE 10,0 mg NALOXONE HYDROCHLORIDE DIHYDRATE EQUIVALENT TO NALOXONE 5,0 mg

10/5 mg530751.74653/2.9/0751.746RegistreredNot determinedNone
Codep xr 20/10 MG

EACH TABLET CONTAINS OXYCODONE HYDROCHLORIDE EQUIVALENT TO OXYCODONE 20,0 mg NALOXONE HYDROCHLORIDE DIHYDRATE EQUIVALENT TO NALOXONE 10,0 mg

20/10 mg530752.74753/2.9/0752.747RegistreredNot determinedNone
Codep xr 30/15 MG

EACH TABLET CONTAINS OXYCODONE HYDROCHLORIDE EQUIVALENT TO OXYCODONE 30,0 mg NALOXONE HYDROCHLORIDE DIHYDRATE EQUIVALENT TO NALOXONE 15,0 mg

30/15 mg530753.74853/2.9/0753.748RegistreredNot determinedNone
Codep xr 40/20 MG

EACH TABLET CONTAINS OXYCODONE HYDROCHLORIDE EQUIVALENT TO OXYCODONE 40,0 mg NALOXONE HYDROCHLORIDE DIHYDRATE EQUIVALENT TO NALOXONE 20,0 mg

40/20 mg530754.74953/2.9/0754.749RegistreredNot determinedNone

Regulatory status

This product is still scheduled by law even when this site could not determine which tier it falls under. The label carries the S number in a square border; ask a pharmacist if you need to know its schedule.

Listings for this ingredient that could not be applied to this product

  • S6: Buprenorphine

    Consolidated Schedules 06 July 2026, line 10099

  • S6: Oxycodone

    Consolidated Schedules 06 July 2026, line 10363

  • S4: Naloxone

    Consolidated Schedules 06 July 2026, line 7206

This is an informational summary of the Medicines and Related Substances Act 101 of 1965 and its 2017 General Regulations. It is not medical advice and not legal advice. Always check the medicine's label, which carries the schedule number inside a square border, or ask a pharmacist if you are unsure.

C19H21NO4327.40 g/mol

(4R,4AS,7aR,12bS)-4a,9-dihydroxy-3-prop-2-enyl-2,4,5,6,7a,13-hexahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one

Drag to rotate. Structure from PubChem CID 5284596.

SAHPRA documents

SAHPRA has not published a professional information or patient information leaflet for this product.

Background

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Research articles

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