Oxybutynin
Sold as Mylan oxybutynin, Oxybutynin oethmaan, Lenditro, Oxyspas, Cipla-oxybutynin chloride, Oxyrest, Lyrinel, Ditropan
4-(Diethylamino)but-2-ynyl 2-cyclohexyl-2-hydroxy-2-phenylacetate
Drag to rotate. Structure from PubChem CID 4634.
Background
Registration
- Applicants
- 8
- Registrations
- 9
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Viatris South Africa (Pty) Ltd | Mylan oxybutynin | 5 | 320740 | S3 | None |
| Oethmaan Biosims (Pty) Ltd | Oxybutynin oethmaan | 5 | 330359 | S3 | None |
| Pharmacare limited û woodmead | Lenditro | Not stated | 330411 | S3 | None |
| Cipla Medpro (Pty) LtdCancelled | Oxyspas | Not stated | 350111 | S3 | None |
| Cipla Life Sciences (Pty) Ltd | Cipla-oxybutynin chloride | Not stated | 350340 | S3 | None |
| Ipharma (Pty) Ltd | Oxyrest | 5 mg | 370106 | S3 | PIPIL |
| Janssen Pharmaceutica (Pty) LtdCancelled | Lyrinel | 5 mg, 10 mg | A390212, A390224 | S3 | None |
| Pharmaco Distribution (Pty) Ltd | Ditropan | 5mg | L0104 | S3 | PIPIL |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Mylan oxybutynin 5 EACH TABLET CONTAINS OXYBUTYNIN CHLORIDE 5,0 mg | 5 | 32074032/5.4/0740 | Registered | S3 | None |
| Oxybutynin 5 oethmaan EACH TABLET CONTAINS OXYBUTYNIN HYDROCHLORIDE 5,0 mg | 5 | 33035933/5.4/0359 | Registered | S3 | None |
| Lenditro EACH TABLET CONTAINS OXYBUTYNIN CHLORIDE 5,0 mg | Not listed | 33041133/5.4/0411 | Registered | S3 | None |
| Oxyspas EACH TABLET CONTAINS OXYBUTYNIN CHLORIDE 5,0 mg | Not listed | 35011135/5.4/0111 | Cancelled | S3 | None |
| Cipla-oxybutynin chloride EACH TABLET CONTAINS OXYBUTYNIN CHLORIDE 5,0 mg | Not listed | 35034035/5.4/0340 | Registered | S3 | None |
| Oxyrest EACH TABLET CONTAINS OXYBUTYNIN CHLORIDE 5,0 mg | 5 mgTablets | 37010637/5.4/0106Approved 1 November 2019 | Registered | S3 | PIPIL |
| Lyrinel 5 MG EACH TABLET CONTAINS OXYBUTYNIN CHLORIDE 5,0 mg | 5 mg | A390212A39/5.4/0212 | Cancelled | S3 | None |
| Lyrinel 10 MG EACH TABLET CONTAINS OXYBUTYNIN CHLORIDE 10,0 mg | 10 mg | A390224A39/5.4/0224 | Cancelled | S3 | None |
| Ditropan EACH TABLET CONTAINS OXYBUTYNIN CHLORIDE 5 mg | 5mgTablet | L0104L/5.4/104Approved 20 January 2020 | Registered | S3 | PIPIL |
Regulatory status
Where S3 sits on the scale
Needs a doctor's prescription, dispensed by a pharmacist.
Schedule 3 medicines can only be sold on a prescription from an authorised prescriber, such as a doctor or dentist. A pharmacist dispenses the medicine once they have the written prescription, or a verbal instruction from a prescriber they know. Its price, name, pack size and strength can still be told to the public, as long as nothing links it to what it treats.
Schedule S3, matched to the Consolidated Schedules by ingredient, confidence high.
Who may supply: A pharmacist dispensing against a written or verbal prescription from an authorised prescriber; a veterinarian, who may also prescribe, compound or dispense it directly; a medical practitioner or dentist, who may prescribe it and may compound or dispense it directly only if licensed under section 22C(1)(a); manufacturers and wholesalers may supply people who may lawfully possess it; and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.
Consolidated Schedules listings for Oxybutynin chloride
S3: Oxybutynin
Consolidated Schedules 06 July 2026, line 4085
Pharmacological class: Cholinolytics ( anticholinergics). (class 5.4)
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.
SAHPRA documents
Schedule Verification
Oxyrest, Ipharma (Pty) Ltd is scheduled S3 in its official SAHPRA documents, read with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.