Phenytoin
Sold as Phlexy, Phenytoin sodium ascendis, Phenpatin, Aspen phenytoin sodium, Epanutin, Epanutin forte, Phenytoin sodium, Norstan-phenytoin sodium, Epanutin ready-mixed parenteral, Sabax phenytoin sodium
5,5-Diphenylimidazolidine-2,4-dione
Drag to rotate. Structure from PubChem CID 1775.
Background
Registration
- Applicants
- 7
- Registrations
- 12
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Austell Pharmaceuticals (Pty) Ltd | Phlexy | 250 mg/5 ml | 450493 | S3 | None |
| Ascendis Pharma (Pty) Ltd | Phenytoin sodium ascendis | 250 mg/5 ml | 450495 | S3 | None |
| Arya Pharma (Pty) Ltd | Phenpatin | 50 mg/ml | 560269 | S3 | None |
| Pharmacare limited û woodmead1 of 4 cancelled | Aspen phenytoin sodium, Phenytoin sodium, Norstan-phenytoin sodium | 100 mg, 250 mg/5 ml | A400004, B0884, B0885, B1366 | S3 | None |
| Warner-lambert SA (Pty) LtdCancelled | Epanutin | 50 MG | B0553 | S3 | None |
| Viatris Healthcare (Pty) Ltd | Epanutin, Epanutin forte, Epanutin ready-mixed parenteral | 5 ml, 100 mg | B0554, B0555, B1624 | S3 | PIPIL |
| Adcock Ingram Critical Care (Pty) Ltd | Sabax phenytoin sodium | 50 mg/ml | Z0004 | S3 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Phlexy 250 mg/5 ML EACH 5,0 ml SOLUTION CONTAINS: PHENYTOIN SODIUM 250,0 mg | 250 mg/5 ml | 45049345/2.5/0493 | Registered | S3 | None |
| Phenytoin sodium 250 mg/5 ML ascendis EACH 5,0 ml SOLUTION CONTAINS PHENYTOIN SODIUM 250,0 mg | 250 mg/5 ml | 45049545/2.5/0495 | Registered | S3 | None |
| Phenpatin 50 mg/ml EACH 1,0 ml SOLUTION CONTAINS PHENYTOIN SODIUM 50,0 mg | 50 mg/ml | 56026956/2.5/0269 | Registered | S3 | None |
| Aspen phenytoin sodium 250 mg/5 ML EACH 5,0 ml SOLUTION CONTAINS PHENYTOIN SODIUM 250,0 mg | 250 mg/5 ml | A400004A40/2.5/0004 | Registered | S3 | None |
| Epanutin 50 MG CAPSULE PHENYTOIN SODIUM A 50 MG | 50 MG | B0553 | Cancelled | S3 | None |
| Epanutin 100 MG EACH CAPSULE CONTAINS PHENYTOIN SODIUM A 100,0 mg | 100 mg | B0554 | Old Medicine | S3 | None |
| Epanutin forte suspension EACH 5,0 ml SUSPENSION CONTAINS PHENYTOIN A 125,0 mg | 5 mlSuspension | B0555Approved 6 October 2022 | Old Medicine | S3 | PIPIL |
| Phenytoin sodium EACH TABLET CONTAINS PHENYTOIN SODIUM A 100 MG | Not listed | B0884 | Old Medicine | S3 | None |
| Phenytoin sodium capsules 100 MG EACH CAPSULE CONTAINS PHENYTOIN SODIUM A 100 MG | 100 mgCapsules | B0885 | Old Medicine | S3 | None |
| Norstan-phenytoin sodium EACH TABLET CONTAINS PHENYTOIN SODIUM A 100 mg | Not listed | B1366 | Cancelled | S3 | None |
| Epanutin ready-mixed parenteral EACH 1,0 ml SOLUTION CONTAINS PHENYTOIN SODIUM A 50,0 mg | Not listed | B1624 | Old Medicine | S3 | None |
| Sabax phenytoin sodium 50 mg/ml injection EACH 5 ml SOLUTION CONTAINS PHENYTOIN SODIUM 250 mg | 50 mg/mlInjection | Z0004Z/2.5/4 | Registered | S3 | None |
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 Phenytoin sodium
S3: Phenytoin
Consolidated Schedules 06 July 2026, line 4122
Pharmacological class: Anticonvulsants, including anti-epileptics. (class 2.5)
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
Epanutin forte suspension, Viatris Healthcare (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.