5-fluorouracil
Sold as Fluorouracil-faulding, Fluracedyl, Fluroplex, Cipla fluorouracil, Efudix, Bitural, Fluroblastin
5-Fluoro-1H-pyrimidine-2,4-dione
Drag to rotate. Structure from PubChem CID 3385.
Background
Registration
- Applicants
- 5
- Registrations
- 11
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Pfizer Laboratories (Pty) Ltd1 of 2 cancelled | Fluorouracil-faulding, Fluroblastin | 50 mg/ml | 290362, Q0109 | S4 | None |
| Teva Pharmaceuticals (Pty) Ltd1 of 4 cancelled | Fluracedyl | 250 mg, 500 mg, 1000 mg, 5000 mg | 350144, 350349, 350350, 350351 | S4 | None |
| Cipla Medpro (Pty) LtdCancelled | Fluroplex, Cipla fluorouracil | Not stated | 450210, 450211 | S4 | None |
| Viatris Healthcare (Pty) LtdCertificate held by Mylan (Pty) Ltd | Efudix | 50 mg/g Ð 20 g | D0122 | S4 | PIPIL |
| Pharmacare limited û woodmeadCancelled | Bitural | cream, injection | M0189, P0094 | S4 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Fluorouracil-faulding 50 mg/ml EACH 1 ml SOLUTION CONTAINS 5-FLUOROURACIL 50 mg | 50 mg/ml | 29036229/26/0362 | Registered | S4 | None |
| Fluracedyl 250 MG EACH 1,0 ml SOLUTION CONTAINS 5-FLUOROURACIL A 50,0 mg | 250 mg | 35014435/26/0144 | Cancelled | S4 | None |
| Fluracedyl 500 MG EACH 1,0 ml SOLUTION CONTAINS 5-FLUOROURACIL 50,0 mg | 500 mg | 35034935/26/0349 | Registered | S4 | None |
| Fluracedyl 1000 MG EACH 1,0 ml SOLUTION CONTAINS 5-FLUOROURACIL 50,0 mg | 1000 mg | 35035035/26/0350 | Registered | S4 | None |
| Fluracedyl 5000 MG EACH 1,0 ml SOLUTION CONTAINS 5-FLUOROURACIL 50,0 mg | 5000 mg | 35035135/26/0351 | Registered | S4 | None |
| Fluroplex EACH 10,0 ml VIAL CONTAINS 5-FLUOROURACIL 500,0 mg | Not listed | 45021045/26/0210 | Cancelled | S4 | None |
| Cipla fluorouracil EACH 10,0 ml VIAL CONTAINS 5-FLUOROURACIL 500,0 mg | Not listed | 45021145/26/0211 | Cancelled | S4 | None |
| Efudix EACH 100 g OINTMENT CONTAINS 5-FLUOROURACIL 5 g | 50 mg/g Ð 20 gOintment | D0122D/13.8/122Approved 14 February 2020 | Registered | S4 | PIPIL |
| Bitural cream EACH 100 g CREAM CONTAINS 5-FLUOROURACIL 5 g | Cream | M0189M/13.8/189 | Cancelled | S4 | None |
| Bitural injection EACH 5 ml SOLUTION CONTAINS 5-FLUOROURACIL 250 mg | Injection | P0094P/26/94 | Cancelled | S4 | None |
| Fluroblastin EACH VIAL CONTAINS 5-FLUOROURACIL 500 mg | Not listed | Q0109Q/26/109 | Cancelled | S4 | None |
Regulatory status
Where S4 sits on the scale
Prescription-only medicine.
Schedule 4 covers most ordinary prescription medicines. You need a prescription from an authorised prescriber, such as a doctor or dentist, and a pharmacist dispenses it. 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 S4, 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 5-fluorouracil
S4: 5-fluorouracil
Consolidated Schedules 06 July 2026, line 6386
Pharmacological class: Cytostatic agents (class 26)
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
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.