Nitrofurantoin
Sold as Unitro, Zoczen, Macrixtir, Nitrofurantoin PHARMC, Furantogen, Nitrofurantoin emcure, Suforoin, Renoftra
1-[(E)-(5-Nitrofuran-2-yl)methylideneamino]imidazolidine-2,4-dione
Drag to rotate. Structure from PubChem CID 6604200.
Background
Registration
- Applicants
- 5
- Registrations
- 15
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Aurogen South Africa (Pty) LtdCertificate held by Aurogen SA (Pty) Ltd2 of 6 cancelled | Unitro, Zoczen, Macrixtir | 50, 100 | 550207, 550208, 550209.207, 550210.208, 550211.207, 550212.208 | S4 | PIPIL |
| Pharmacorp (Pty) Ltd | Nitrofurantoin PHARMC | 50, 100 | 550862, 550863 | Not determined | None |
| Novagen Pharma (Pty) Ltd | Furantogen | 50, 100 | 550908, 550909 | Not determined | None |
| Emcure- Pharmaceutical South Africa (Pty) Ltd | Nitrofurantoin emcure, Suforoin | 50 mg, 100 mg | 561015, 561016, 561017.1015, 561018.1016 | Not determined | None |
| RBC Pharmaceuticals (Pty) Ltd | Renoftra | 100 mg | 590553 | S4 | PIPIL |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Unitro 50 EACH CAPSULE CONTAINS NITROFURANTOIN 50,0 mg | 50Capsule | 55020755/18.5/0207Approved 1 February 2022 | Registered | S4 | PIPIL |
| Unitro 100 EACH CAPSULE CONTAINS NITROFURANTOIN 100,0 mg | 100Capsule | 55020855/18.5/0208Approved 1 February 2022 | Registered | S4 | PIPIL |
| Zoczen 50 EACH CAPSULE CONTAINS NITROFURANTOIN 50,0 mg | 50Capsule | 550209.20755/18.5/0209.207Approved 1 February 2022 | Registered | S4 | PIPIL |
| Zoczen 100 EACH CAPSULE CONTAINS NITROFURANTOIN 100,0 mg | 100Capsule | 550210.20855/18.5/0210.208Approved 1 February 2022 | Registered | S4 | PIPIL |
| Macrixtir 50 EACH CAPSULE CONTAINS NITROFURANTOIN 50,0 mg | 50 | 550211.20755/18.5/0211.207 | Cancelled | Not determined | None |
| Macrixtir 100 EACH CAPSULE CONTAINS: NITROFURANTOIN 100,0 mg | 100 | 550212.20855/18.5/0212.208 | Cancelled | Not determined | None |
| Nitrofurantoin 50 PHARMC EACH CAPSULE CONTAINS NITROFURANTOIN 50,0 mg | 50 | 55086255/18.5/0862 | Registered | Not determined | None |
| Nitrofurantoin 100 PHARMC EACH CAPSULE CONTAINS NITROFURANTOIN 100,0 mg | 100 | 550863 | Registered | Not determined | None |
| Furantogen 50 EACH CAPSULE CONTAINS NITROFURANTOIN 50,0 mg | 50 | 55090855/18.5/0908 | Registered | Not determined | None |
| Furantogen 100 EACH CAPSULE CONTAINS NITROFURANTOIN 100,0 mg | 100 | 55090955/18.5/0909 | Registered | Not determined | None |
| Nitrofurantoin 50 MG emcure EACH CAPSULE CONTAINS NITROFURANTOIN 50,0 mg | 50 mg | 56101556/18.5/1015 | Registered | Not determined | None |
| Nitrofurantoin 100 MG emcure EACH CAPSULE CONTAINS NITROFURANTOIN 100,0 mg | 100 mg | 56101656/18.5/1016 | Registered | Not determined | None |
| Suforoin 50 MG EACH CAPSULE CONTAINS NITROFURANTOIN 50,0 mg | 50 mg | 561017.101556/18.5/1017.1015 | Registered | Not determined | None |
| Suforoin 100 MG EACH CAPSULE CONTAINS NITROFURANTOIN 100,0 mg | 100 mg | 561018.101656/18.5/1018.1016 | Registered | Not determined | None |
| Renoftra 100 EACH CAPSULE CONTAINS: NITROFURANTOIN 100,0 mg | 100 mgHard gelatin capsule | 59055359/18.5/0553Approved 26 May 2026 | Registered | S4 | PIPIL |
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, read from the product's PI-PIL leaflet.
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 Nitrofurantoin
S4: Nitrofurantoin
- except preparations thereof intended for application to the skin.
Consolidated Schedules 06 July 2026, line 7287
S1: Nitrofurantoin
- when intended for application to the skin.
Consolidated Schedules 06 July 2026, line 919
Pharmacological class: Urinary tract antiseptics. (class 18.5)
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
Unitro 50, Aurogen South Africa (Pty) Ltd is scheduled S4 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.