Azithromycin (Zithromax, Ultreon, Zithromax Iv, Zithromax One)
Azithromycin
Pfizer Laboratories (Pty) Ltd
Registration
- Applicant
- Pfizer Laboratories (Pty) Ltd
- Registrations
- 5
- Schedule source
- Consolidated Schedules 06 July 2026
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Zithromax 200 mg/5 ML EACH 5 ml SUSPENSION CONTAINS AZITHROMYCIN DIHYDRATE EQUIVALENT TO AZITHROMYCIN 200 mg | 200 mg/5 ml | 27027927/20.1.1/0279 | Registered | S4 | None |
| Zithromax 500 MG EACH TABLET CONTAINS AZITHROMYCIN DIHYDRATE EQUIVALENT TO 500,0 mg AZITHROMYCIN | 500 mg | 31004531/20.1.1/0045 | Registered | S4 | None |
| Ultreon 500 MG PER FILM-COATED TABLET AZITHROMYCIN DIHYDRATE EQUIVALENT TO AZITHROMYCIN 500 mg | 500 mg | 31004631/20.1.1/0046 | Registered | S4 | None |
| Zithromax iv EACH VIAL CONTAINS AZITHROMYCIN DIHYDRATE EQUIVALENT TO AZITHROMYCIN 500,0 mg | Not listed | 36019036/20.1.1/0190 | Registered | S4 | None |
| Zithromax one EACH BOTTLE CONTAINS AZITHROMYCIN DIHYDRATE EQUIVALENT TO AZITHROMYCIN 2,0 g | Not listed | A400102A40/20.1.1/0102 | 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 Azithromycin dihydrate equivalent to azithromycin
S4: Azithromycin
Consolidated Schedules 06 July 2026, line 5409
Pharmacological class: Broad and medium spectrum antibiotics. (class 20.1.1)
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.
No structure available
This product's active ingredient could not be matched to a single known compound.
SAHPRA documents
SAHPRA has not published a professional information or patient information leaflet for this product.