Azithromycin
Sold as Zithromax, Ultreon, Clamelle, Varimax, Azimax, Zithromax iv, Aspen azithromycin, Aspen azithromycin iv, Zitro, Cipla azithromycin, Cipla azithromycin inj, Azero, Azimax forte, Zithrolide, Azithromycin unicorn, Azithromycin s aspen, Zithract, Azithromycin s biotech, Azithromycin austell, Zatyp, Myzat, Zimozar, Novazith, Azithromycin new formula, Ceptomax, Zathrin, Zithrogen, Austell azithromycin, Azihexal, Azithromycin hexal, Zithromax one, Binozyt, Sandoz azithromycin
No structure available
This product's active ingredient could not be matched to a single known compound.
Background
Registration
- Applicants
- 18
- Registrations
- 38
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Pfizer Laboratories (Pty) Ltd1 of 5 cancelled | Zithromax, Ultreon, Zithromax iv, Zithromax one | 200 mg/5 ml, 500 mg | 270279, 310045, 310046, 360190, A400102 | S4 | None |
| Cipla Life Sciences (Pty) LtdCertificate held by Strides Pharma (SA) (Pty) Ltd | Clamelle | 250 mg | 330269 | S4 | PIPIL |
| Dezzo Trading 392 (Pty) LtdCertificate held by Shanur Healthcare (Pty) Ltd, | Varimax, Azihexal | 250 mg, 500 mg | 360164, A390128 | S4 | PIPIL |
| Unimed Healthcare (Pty) Ltd | Azimax, Azimax forte | Not stated | 360165, 450246 | S4 | None |
| Pharmacare limited û woodmead1 of 4 cancelled | Aspen azithromycin, Aspen azithromycin iv, Azithromycin s aspen, Azithromycin new formula | 500 mg | 370222, 420247, 480224, 520305 | S4 | None |
| Cipla Medpro (Pty) Ltd2 of 5 cancelled | Zitro, Cipla azithromycin, Cipla azithromycin inj, Zithract | 500 | 420505, 420506, 430612, 430614, 480764 | S4 | None |
| Zydus Healthcare (Pty) Ltd | Azero | Not stated | 440492 | S4 | None |
| Jubilant Pharma SA (Pty) Ltd | Zithrolide | 250, 500 | 450969, 450970 | S4 | None |
| Unicorn Pharmaceuticals (Pty) Ltd | Azithromycin unicorn | 500 mg | 451076 | S4 | None |
| Biotech Laboratories (Pty) Ltd | Azithromycin s biotech, Azithromycin hexal | 500 mg | 491032, A390382 | S4 | None |
| Austell Pharmaceuticals (Pty) LtdCertificate held by Austell Pharmaceuticals (Pty) Ltd, | Azithromycin austell | 200 mg/5 mL | 500567 | S4 | PIPIL |
| Aurogen South Africa (Pty) Ltd1 of 4 cancelled | Zatyp, Myzat, Zimozar | 200 mg/5ml, 500 mg | 500755, 510267, 510268.267, 510269.267 | S4 | PIPIL |
| Novagen Pharma (Pty) Ltd | Novazith | 200 mg/5ml | 510587 | S4 | PIPIL |
| Innovata pharmaceuticalsCertificate held by Innovata Pharmaceuticals (Pty) Ltd | Ceptomax | 200 mg | 550733 | S4 | PIPIL |
| FDC SA (Pty) Ltd | Zathrin | 500 mg | 570379 | S4 | None |
| Viatris South Africa (Pty) Ltd | Zithrogen | 250, 500 | A380692, A380693 | S4 | None |
| Camox Pharmaceuticals (Pty) Ltd | Austell azithromycin | 500 mg | A390020 | S4 | None |
| Sandoz South Africa (Pty) LtdCancelled | Binozyt, Sandoz azithromycin | 500 | A400333, A400334 | S4 | None |
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 |
| Clamelle EACH CAPSULE CONTAINS AZITHROMYCIN DIHYDRATE EQUIVALENT TO AZITHROMYCIN 250,0 mg | 250 mgCapsules. | 33026933/20.1.1/0269Approved 21 April 2023 | Registered | S4 | PIPIL |
| Varimax EACH CAPSULE CONTAINS AZITHROMYCIN DIHYDRATE EQUIVALENT TO AZITHROMYCIN 250,0 mg | 250 mgCapsules. | 36016436/20.1.1/0164Approved 19 April 2024 | Registered | S4 | PIPIL |
| Azimax EACH CAPSULE CONTAINS AZITHROMYCIN DIHYDRATE EQUIVALENT TO AZITHROMYCIN 250,0 mg | Not listed | 36016536/20.1.1/0165 | 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 |
| Aspen azithromycin 500 MG EACH TABLET CONTAINS AZITHROMYCIN MONOHYDRATE EQUIVALENT TO AZITHROMYCIN 500,0 mg | 500 mg | 37022237/20.1.1/0222 | Registered | S4 | None |
| Aspen azithromycin iv EACH VIAL CONTAINS AZITHROMYCIN 500,0 mg | Not listed | 42024742/20.1.1/0247 | Cancelled | S4 | None |
| Zitro 500 tablets EACH TABLET CONTAINS AZITHROMYCIN DIHYDRATE EQUIVALENT TO AZITHROMYCIN 500,0 mg | 500Tablets | 42050542/20.1.1/0505 | Cancelled | S4 | None |
| Cipla azithromycin 500 EACH TABLET CONTAINS AZITHROMYCIN DIHYDRATE EQUIVALENT TO AZITHROMYCIN 500,0 mg | 500 | 42050642/20.1.1/0506 | Registered | S4 | None |
| Cipla azithromycin 500 inj EACH VIAL CONTAINS AZITHROMYCIN DIHYDRATE EQUIVALENT TO AZITHROMYCIN 500,0 mg | 500 | 43061243/20.1.1/0612 | Registered | S4 | None |
| Zitro 500 injection EACH VIAL CONTAINS AZITHROMYCIN DIHYDRATE EQUIVALENT TO AZITHROMYCIN 500,0 mg | 500Injection | 43061443/20.1.1/0614 | Cancelled | S4 | None |
| Azero EACH TABLET CONTAINS AZITHROMYCIN DIHYDRATE EQUIVALENT TO AZITHROMYCIN 500,0 mg | Not listed | 44049244/20.1.1/0492 | Registered | S4 | None |
| Azimax forte Each Tablet contains: Azithromycin 500,0 mg | Not listed | 45024645/20.1.1/0246 | Registered | S4 | None |
| Zithrolide 250 EACH TABLET CONTAINS AZITHROMYCIN DIHYDRATE EQUIVALENT TO AZITHROMYCIN 250,0 mg | 250 | 45096945/20.1.1/0969 | Registered | S4 | None |
| Zithrolide 500 EACH TABLET CONTAINS AZITHROMYCIN DIHYDRATE EQUIVALENT TO AZITHROMYCIN 500,0 mg | 500 | 45097045/20.1.1/0970 | Registered | S4 | None |
| Azithromycin unicorn 500 MG EACH TABLET CONTAINS : AZITHROMYCIN DIHYDRATE EQUIVALENT TO AZITHROMYCIN 500,0 mg | 500 mg | 45107645/20.1.1/1076 | Registered | S4 | None |
| Azithromycin s aspen EACH 5 ml CONTAINS AZITHROMYCIN DIHYDRATE EQUIVALENT TO AZITHROMYCIN 200, 0 mg | Not listed | 48022448/20.1.1/0224 | Registered | S4 | None |
| Zithract Each Table contains: Azithromycin Dihydrate equivalent to Azithromycin 500,0 mg | Not listed | 48076448/20.1.1/0764 | Registered | S4 | None |
| Azithromycin s biotech EACH 5 ml CONTAINS AZITHROMYCIN DIHYDRATE EQUIVALENT TO AZITHROMYCIN 200,0 mg | Not listed | 49103249/20.1.1/1032 | Registered | S4 | None |
| Azithromycin 200 mg/5 ML austell EACH 5,0 ml SUSPENSION CONTAINS :AZITHROMYCIN DIHYDRATE EQUIVALENT TO AZITHROMYCIN 200,0 mg | 200 mg/5 mLPowder for oral suspension | 50056750/20.1.1/0567Approved 16 March 2026 | Registered | S4 | PIPIL |
| Zatyp tablets | 500 mgFilm coated tablet | 50075550/20.1.1/0755Approved 10 November 2020 | Registered | S4 | PIPIL |
| Myzat | 200 mg/5mlPowder for oral suspension | 51026751/20.1.1/0267Approved 28 July 2020 | Registered | S4 | PIPIL |
| Zimozar EACH 5,0 ML SOLUTION CONTAINS: AZITHROMYCIN DIHYDRATE EQUIVALENT TO AZITHROMYCIN 200,0 mg | 500 mgFilm coated tablet | 510268.26751/20.1.1/0268.267Approved 10 November 2020 | Cancelled | S4 | PIPIL |
| Zatyp oral suspension | 200 mg/5mlPowder for oral suspension | 510269.26751/20.1.1/0269.267Approved 28 July 2020 | Registered | S4 | PIPIL |
| Novazith suspension | 200 mg/5mlPowder for oral suspension | 51058751/20.1.1/0587Approved 3 November 2020 | Registered | S4 | PIPIL |
| Azithromycin new formula EACH FILM-COATED TABLET CONTAINS: AZITHROMYCIN DIHYDRATE EQUIVALENT TO AZITHROMYCIN 500, 0 mg | Not listed | 52030552/20.1.1/0305 | Registered | S4 | None |
| Ceptomax 200 mg/5 ML AZITHROMYCIN | 200 mgPowder for oral suspension | 55073355/20.1.1/0733Approved 14 July 2025 | Registered | S4 | PIPIL |
| Zathrin 500 MG EACH TABLET CONTAINS: AZITHROMYCIN 500,0 mg | 500 mg | 57037957/20.1.1/0379 | Registered | S4 | None |
| Zithrogen 250 EACH TABLET CONTAINS AZITHROMYCIN 250,0 mg | 250 | A380692A38/20.1.1/0692 | Registered | S4 | None |
| Zithrogen 500 EACH TABLET CONTAINS AZITHROMYCIN 500,0 mg | 500 | A380693A38/20.1.1/0693 | Registered | S4 | None |
| Austell azithromycin 500 MG EACH TABLET CONTAINS :AZITHROMYCIN DIHYDRATE EQUIVALENT TO AZITHROMYCIN 500,0 mg | 500 mg | A390020A39/20.1.1/0020 | Registered | S4 | None |
| Azihexal 500 MG EACH TABLET CONTAINS AZITHROMYCIN DIHYDRATE EQUIVALENT TO AZITHROMYCIN 500,0 mg | 500 mg | A390128A39/20.1.1/0128 | Registered | S4 | None |
| Azithromycin hexal 500 MG tablet EACH TABLET CONTAINS AZITHROMYCIN DIHYDRATE EQUIVALENT TO AZITHROMYCIN 500,0 mg | 500 mgTablet | A390382A39/20.1.1/0382 | 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 |
| Binozyt 500 EACH TABLET CONTAINS AZITHROMYCIN MONOHYDRATE EQUIVALENT TO AZITHROMYCIN 500,0 mg | 500 | A400333A40/20.1.1/0333 | Cancelled | S4 | None |
| Sandoz azithromycin 500 EACH TABLET CONTAINS AZITHROMYCIN MONOHYDRATE EQUIVALENT TO AZITHROMYCIN 500,0 mg | 500 | A400334A40/20.1.1/0334 | 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.
SAHPRA documents
Schedule Verification
Clamelle, Cipla Life Sciences (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.