Sitagliptin Zydus
(3R)-3-Amino-1-[3-(trifluoromethyl)-6,8-dihydro-5H-[1,2,4]triazolo[4,3-a]pyrazin-7-yl]-4-(2,4,5-trifluorophenyl)butan-1-one
Drag to rotate; arrow keys step through the atoms. Structure from PubChem CID 4369359.
Registration
- Applicants
- 1
- Registrations
- 6
- Schedule source
- SAHPRA documentation
Applicants and registrations
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Sitagliptin 25 zydus | 25Tablet | 520910.90752/21.2/0910.907Approved 13 September 2022 | Registered | S3 | PIPIL |
| Sitagliptin 50 zydus | 50Tablet | 520911.90852/21.2/0911.908Approved 13 September 2022 | Registered | S3 | PIPIL |
| Sitagliptin 100 zydus | 100Tablet | 520912.90952/21.2/0912.909Approved 13 September 2022 | Registered | S3 | PIPIL |
| Sitagliptin zydus 25 EACH TABLET CONTAINS SITAGLIPTIN PHOSPHATE 25,0 mg | 25Tablet | 550046.04355/21.2/0046.043Approved 13 September 2022 | Registered | S3 | PIPIL |
| Sitagliptin zydus 50 EACH TABLET CONTAINS SITAGLIPTIN PHOSPHATE 50,0 mg | 50Tablet | 550047.04455/21.2/0047.044Approved 13 September 2022 | Registered | S3 | PIPIL |
| Sitagliptin zydus 100 EACH TABLET CONTAINS SITAGLIPTIN PHOSPHATE 100,0 mg | 100Tablet | 550048.04555/21.2/0048.045Approved 13 September 2022 | Registered | S3 | PIPIL |
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, 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 Sitagliptin
S3: Sitagliptin phosphate
Consolidated Schedules 06 July 2026, line 4249
Pharmacological class: Oral hypoglycaemics. (class 21.2)
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.
Background
SAHPRA documents
Schedule Verification
Sitagliptin 25 zydus, Zydus Healthcare (Pty) Ltd is scheduled S3 in its official SAHPRA documents, read with 90% confidence.
These documents come from SAHPRA's PI-PIL repository unless the line under a document says otherwise. Always consult with a healthcare professional for medical advice.