Sitagliptin

Sold as Januvia, Sitagliptin teva, Sitagliptin zydus, Glizeb, Sitagliptin medfour, Glusita, Josisitin, Glypivor, Tinosipt, Sitagliptin hetero, Metplitin, Dibestor, Sitacleod, Stacleod, Zitagluc, Sitagliptin ran, Zitagluc plus, Sitagliptin adco, Glysiptin, Glysenza

C₁₆H₁₅F₆N₅O407.31 g/mol

(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. Structure from PubChem CID 4369359.

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Registration

Applicants: 15
Registrations: 58
Schedule source: Consolidated Schedules 06 July 2026

Applicants and registrations

Applicant	Brands	Dosages	Registrations	Schedule	Leaflets
Msd (Pty) LtdCertificate held by Msd	Januvia	25, 50, 100	410354, 410355, 410356	S3	PI PIL
Teva Pharmaceuticals (Pty) LtdCancelled	Sitagliptin teva	25 mg, 50 mg, 100 mg	510929, 510930, 510931	S3	None
Zydus Healthcare (Pty) LtdCertificate held by Zydus Healthcare SA (Pty) Ltd	Sitagliptin zydus, Glizeb	25, 50, 100	520910.907, 520911.908, 520912.909, 550043, 550044, 550045, 550046.043, 550047.044, 550048.045	S3	PI PIL
Medfour Healthcare CCCancelled	Sitagliptin medfour	25 mg, 50 mg, 100 mg	550441, 550442, 550443	Not determined	None
Sandoz South Africa (Pty) Ltd	Glusita, Josisitin	25 mg, 50 mg, 100 mg	550694, 550695, 550696, 550697.694, 550698.695, 550699.696	S3	None
Pharma Dynamics (Pty) LtdCancelled	Glypivor	25 mg, 50 mg, 100 mg	560169, 560170, 560171	S3	None
Hetero Drugs South Africa (Pty) Ltd	Tinosipt, Sitagliptin hetero	25 mg, 50 mg, 100 mg	560650, 560651, 560652, 560653.650, 560654.651, 560655.652	S3	None
Dr Reddyæs Laboratories (Pty) Ltd	Metplitin	25 mg, 50 mg, 100 mg	560996, 560997, 560998	Not determined	None
Trinity Pharma (Pty) Ltd	Dibestor	25, 50, 100	561044, 561045, 561046	S3	PI PIL
Macleods Pharmaceuticals SA (Pty) Ltd	Sitacleod, Stacleod	25, 50, 100	561159, 561160, 561161	S3	None
Ranbaxy Pharmaceutical (Pty) Ltd2 of 6 cancelled	Zitagluc, Sitagliptin ran, Zitagluc plus	25, 50, 50/1 000, 100	570009, 570010, 570011, 570012.009, 570013.010, 570067	S3	None
Ranbaxy Pharmaceuticals (Pty) LtdCancelled	Sitagliptin ran	100	570014.011	S3	None
Adcock ingram limited	Sitagliptin adco	25 mg, 50 mg, 100 mg	570109, 570110, 570111	S3	None
Accord Healthcare (Pty) Ltd	Glysiptin	25 mg, 50 mg, 100 mg	570754, 570755, 570756	S3	None
Ipharma (Pty) Ltd	Glysenza	25, 50, 100	570868, 570869, 570870	S3	None

Variants

Product	Strength and form	Registration	Status	Schedule	Leaflets
Januvia 25 EACH TABLET CONTAINS SITAGLIPTIN PHOSPHATE EQUIVALENT TO SITAGLIPTIN 25,0 mg	25Tablet	41035441/21.2/0354Approved 17 July 2020	Registered	S3	PI PIL
Januvia 50 EACH TABLET CONTAINS SITAGLIPTIN PHOSPHATE EQUIVALENT TO SITAGLIPTIN 50,0 mg	50Tablet	41035541/21.2/0355Approved 17 July 2020	Registered	S3	PI PIL
Januvia 100 EACH TABLET CONTAINS SITAGLIPTIN PHOSPHATE EQUIVALENT TO SITAGLIPTIN 100,0 mg	100Tablet	41035641/21.2/0356Approved 17 July 2020	Registered	S3	PI PIL
Sitagliptin teva 25 MG EACH FILM-COATED TABLET CONTAINS: SITAGLIPTIN MALATE EQUIVALENT TO SITAGLIPTIN 25,0 mg	25 mg	51092951/21.2/0929	Cancelled	S3	None
Sitagliptin teva 50 MG EACH FILM-COATED TABLET CONTAINS: SITAGLIPTIN MALATE EQUIVALENT TO SITAGLIPTIN 50,0 mg	50 mg	51093051/21.2/0930	Cancelled	S3	None
Sitagliptin teva 100 MG EACH FILM-COATED TABLET CONTAINS: SITAGLIPTIN MALATE EQUIVALENT TO SITAGLIPTIN 100,0 mg	100 mg	51093151/21.2/0931	Cancelled	S3	None
Sitagliptin 25 zydus	25Tablet	520910.90752/21.2/0910.907Approved 13 September 2022	Registered	S3	PI PIL
Sitagliptin 50 zydus	50Tablet	520911.90852/21.2/0911.908Approved 13 September 2022	Registered	S3	PI PIL
Sitagliptin 100 zydus	100Tablet	520912.90952/21.2/0912.909Approved 13 September 2022	Registered	S3	PI PIL
Glizeb 25 EACH TABLET CONTAINS SITAGLIPTIN PHOSPHATE 25,0 mg	25Tablet	55004355/21.2/0043Approved 13 September 2022	Registered	S3	PI PIL
Glizeb 50 EACH TABLET CONTAINS SITAGLIPTIN PHOSPHATE 50,0 mg	50Tablet	55004455/21.2/0044Approved 13 September 2022	Registered	S3	PI PIL
Glizeb 100 EACH TABLET CONTAINS SITAGLIPTIN PHOSPHATE 100,0 mg	100Tablet	55004555/21.2/0045Approved 13 September 2022	Registered	S3	PI PIL
Sitagliptin zydus 25 EACH TABLET CONTAINS SITAGLIPTIN PHOSPHATE 25,0 mg	25Tablet	550046.04355/21.2/0046.043Approved 13 September 2022	Registered	S3	PI PIL
Sitagliptin zydus 50 EACH TABLET CONTAINS SITAGLIPTIN PHOSPHATE 50,0 mg	50Tablet	550047.04455/21.2/0047.044Approved 13 September 2022	Registered	S3	PI PIL
Sitagliptin zydus 100 EACH TABLET CONTAINS SITAGLIPTIN PHOSPHATE 100,0 mg	100Tablet	550048.04555/21.2/0048.045Approved 13 September 2022	Registered	S3	PI PIL
Sitagliptin 25 MG medfour EACH TABLET CONTAINS SITAGLIPTIN HYDROCHLORIDE 25,0 mg	25 mg	55044155/21.2/0441	Cancelled	Not determined	None
Sitagliptin 50 MG medfour EACH TABLET CONTAINS SITAGLIPTIN HYDROCHLORIDE 50,0 mg	50 mg	55044255/21.2/0442	Cancelled	Not determined	None
Sitagliptin 100 MG medfour EACH TABLET CONTAINS SITAGLIPTIN HYDROCHLORIDE 100,0 mg	100 mg	55044355/21.2/0443	Cancelled	Not determined	None
Glusita 25 MG Each Tablet Contains: Sitagliptin Phosphate Monohydrate Equivalent to Sitagliptin 25 mg	25 mg	55069455/21.2/0694	Registered	S3	None
Glusita 50 MG Each Tablet Contains: Sitagliptin Phosphate Monohydrate Equivalent to Sitagliptin 50 mg	50 mg	55069555/21.2/0695	Registered	S3	None
Glusita 100 MG Each Tablet Contains: Sitagliptin Phosphate Monohydrate Equivalent to Sitagliptin 100 mg	100 mg	55069655/21.2/0696	Registered	S3	None
Josisitin 25 MG Each Tablet Contains: Sitagliptin Phosphate Monohydrate Equivalent to Sitagliptin 25 mg	25 mg	550697.69455/21.2/0697.694	Registered	S3	None
Josisitin 50 MG Each Tablet Contains: Sitagliptin Phosphate Monohydrate Equivalent to Sitagliptin 50 mg	50 mg	550698.69555/21.2/0698.695	Registered	S3	None
Josisitin 100 MG Each Tablet Contains: Sitagliptin Phosphate Monohydrate Equivalent to Sitagliptin 100 mg	100 mg	550699.69655/21.2/0699.696	Registered	S3	None
Glypivor 25 MG EACH TABLET CONTAINS SITAGLIPTIN PHOSPHATE EQUIVALENT TO SITAGLIPTIN 25,0 mg	25 mg	56016956/21.2/0169	Cancelled	S3	None
Glypivor 50 MG EACH TABLET CONTAINS SITAGLIPTIN PHOSPHATE EQUIVALENT TO SITAGLIPTIN 50,0 mg	50 mg	56017056/21.2/0170	Cancelled	S3	None
Glypivor 100 MG EACH TABLET CONTAINS SITAGLIPTIN PHOSPHATE EQUIVALENT TO SITAGLIPTIN 100,0 mg	100 mg	56017156/21.2/0171	Cancelled	S3	None
Tinosipt 25 MG EACH TABLET CONTAINS: SITAGLIPTIN HYDROCHLORIDE MONOHYDRATE EQUIVALENT TO SITAGLIPTIN 25,0 mg	25 mg	56065056/21.2/0650	Registered	S3	None
Tinosipt 50 MG EACH TABLET CONTAINS: SITAGLIPTIN HYDROCHLORIDE MONOHYDRATE EQUIVALENT TO SITAGLIPTIN 50,0 mg	50 mg	56065156/21.2/0651	Registered	S3	None
Tinosipt 100 MG EACH TABLET CONTAINS: SITAGLIPTIN HYDROCHLORIDE MONOHYDRATE EQUIVALENT TO SITAGLIPTIN 100,0 mg	100 mg	56065256/21.2/0652	Registered	S3	None
Sitagliptin 25 MG hetero EACH TABLET CONTAINS: SITAGLIPTIN HYDROCHLORIDE MONOHYDRATE EQUIVALENT TO SITAGLIPTIN 25,0 mg	25 mg	560653.65056/21.2/0653.650	Registered	S3	None
Sitagliptin 50 MG hetero EACH TABLET CONTAINS: SITAGLIPTIN HYDROCHLORIDE MONOHYDRATE EQUIVALENT TO SITAGLIPTIN 50,0 mg	50 mg	560654.65156/21.2/0654.651	Registered	S3	None
Sitagliptin 100 MG hetero EACH TABLET CONTAINS: SITAGLIPTIN HYDROCHLORIDE MONOHYDRATE EQUIVALENT TO SITAGLIPTIN 100,0 mg	100 mg	560655.65256/21.2/0655.652	Registered	S3	None
Metplitin 25 MG EACH TABLET CONTAINS SITAGLIPTIN HYDROCHLORIDE MONOHYDRATE 25,0 mg	25 mg	56099656/21.2/0996	Registered	Not determined	None
Metplitin 50 MG EACH TABLET CONTAINS SITAGLIPTIN HYDROCHLORIDE MONOHYDRATE 25,0 mg	50 mg	56099756/21.2/0997	Registered	Not determined	None
Metplitin 100 MG EACH TABLET CONTAINS SITAGLIPTIN HYDROCHLORIDE MONOHYDRATE 100,0 mg	100 mg	56099856/21.2/0998	Registered	Not determined	None
Dibestor 25 Each Tablet contains: Sitagliptin Phosphate monohydrate equivalent to Sitagliptin 25,0 mg	25Film coated tablet	56104456/21.2/1044Approved 17 June 2025	Registered	S3	PI PIL
Dibestor 50 Each Tablet contains: Sitagliptin Phosphate monohydrate equivalent to Sitagliptin 50,0 mg	50Film coated tablet	56104556/21.2/1045Approved 17 June 2025	Registered	S3	PI PIL
Dibestor 100 Each Tablet contains: Sitagliptin Phosphate monohydrate equivalent to Sitagliptin 100,0 mg	100Film coated tablet	56104656/21.2/1046Approved 17 June 2025	Registered	S3	PI PIL
Sitacleod 25 Each Tablet contains: Sitagliptin Phosphate monohydrate equivalent to Sitagliptin	25	56115956/21.2/1159	Registered	S3	None
Sitacleod 50 Each Tablet contains: Sitagliptin Phosphate monohydrate equivalent to Sitagliptin 50,0 mg	50	56116056/21.2/1160	Registered	S3	None
Stacleod 100 Each Tablet contains: Sitagliptin Phosphate monohydrate equivalent to Sitagliptin 100,0 mg	100	56116156/21.2/1161	Registered	S3	None
Zitagluc 25 EACH TABLET CONTAINS SITAGLIPTIN FUMARATE EQUIVALENT TO SITAGLIPTIN 25,0 mg	25	57000957/21.2/0009	Registered	S3	None
Zitagluc 50 EACH TABLET CONTAINS SITAGLIPTIN FUMARATE EQUIVALENT TO SITAGLIPTIN 50,0 mg	50	57001057/21.2/0010	Registered	S3	None
Zitagluc 100 EACH TABLET CONTAINS SITAGLIPTIN FUMARATE EQUIVALENT TO SITAGLIPTIN 100,0 mg	100	57001157/21.2/0011	Registered	S3	None
Sitagliptin 25 ran EACH TABLET CONTAINS SITAGLIPTIN FUMARATE EQUIVALENT TO SITAGLIPTIN 25,0 mg	25	570012.00957/21.2/0012.009	Cancelled	S3	None
Sitagliptin 50 ran EACH TABLET CONTAINS SITAGLIPTIN FUMARATE EQUIVALENT TO SITAGLIPTIN 50,0 mg	50	570013.01057/21.2/0013.010	Cancelled	S3	None
Sitagliptin 100 ran EACH TABLET CONTAINS SITAGLIPTIN FUMARATE EQUIVALENT TO SITAGLIPTIN 100,0 mg	100	570014.01157/21.2/0014.011	Cancelled	S3	None
Zitagluc plus 50/1 000 EACH TABLET CONTAINS: SITAGLIPTIN FUMARATE EQUIVALENT TO SITAGLIPTIN 50,0 mg	50/1 000	57006757/21.2/0067	Registered	S3	None
Sitagliptin 25 MG adco EACH TABLET CONTAINS: SITAGLIPTIN HYDROCHLORIDE EQUIVALENT TO SITAGLIPTIN 25,0 mg	25 mg	57010957/21.2/0109	Registered	S3	None
Sitagliptin 50 MG adco EACH TABLET CONTAINS: SITAGLIPTIN HYDROCHLORIDE EQUIVALENT TO SITAGLIPTIN 50,0 mg	50 mg	57011057/21.2/0110	Registered	S3	None
Sitagliptin 100 MG adco EACH TABLET CONTAINS: SITAGLIPTIN HYDROCHLORIDE EQUIVALENT TO SITAGLIPTIN 100,0 mg	100 mg	57011157/21.2/0111	Registered	S3	None
Glysiptin 25 MG EACH TABLET CONTAINS: SITAGLIPTIN PHOSPHATE ANHYDROUS EQUIVALENT TO SITAGLIPTIN 25,0 mg	25 mg	57075457/21.2/0754	Registered	S3	None
Glysiptin 50 MG EACH TABLET CONTAINS: SITAGLIPTIN PHOSPHATE ANHYDROUS EQUIVALENT TO SITAGLIPTIN 50,0 mg	50 mg	57075557/21.2/0755	Registered	S3	None
Glysiptin 100 MG EACH TABLET CONTAINS: SITAGLIPTIN PHOSPHATE ANHYDROUS EQUIVALENT TO SITAGLIPTIN 100,0 mg	100 mg	57075657/21.2/0756	Registered	S3	None
Glysenza 25 EACH TABLET CONTAINS: SITAGLIPTIN PHOSPHATE EQUIVALENT TO SITAGLIPTIN 25,0 mg	25	57086857/21.2/0868	Registered	S3	None
Glysenza 50 EACH TABLET CONTAINS: SITAGLIPTIN PHOSPHATE EQUIVALENT TO SITAGLIPTIN 50,0 mg	50	57086957/21.2/0869	Registered	S3	None
Glysenza 100 EACH TABLET CONTAINS: SITAGLIPTIN PHOSPHATE EQUIVALENT TO SITAGLIPTIN 100,0 mg	100	57087057/21.2/0870	Registered	S3	None

Regulatory status

Where S3 sits on the scale

S0S1S2S3S4S5S6S7S8

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, 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 Sitagliptin phosphate equivalent to 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.

SAHPRA documents

Professional information (PI)For healthcare professionalsJanuvia 25, Msd (Pty) Ltd Patient information leaflet (PIL)For patients and carersJanuvia 25, Msd (Pty) Ltd

These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.

Research articles

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