Montelukast

Sold as Singulair, Topraz, Monte-air, Monte-air sprinkles, Sintrine, Montelukast unicorn, Monteflo, Belair, Minair, Airathon, Airathon sprinkles, Montelukast zydus, Lumont, Monteil, Sintair, Montelukast cipla, Kulair, Montelukast specpharm, Glenmont, Dilair, Adco montelukast chew, Montelukast adco, Antaluko, Montelukast LHC, Montelukast chew biotech, Montelukast biotech, Sinair, Lucan chew, Leutranist, Skizilia, Montelukast accord, Astelair, Leukoblok, Maclutek, Montrahet, Montascend, Telukem, Montelukast alkem, Montash chew, Montash, Singulair sprinkles

C₃₅H₃₆ClNO₃S586.20 g/mol

2-[1-[[(1R)-1-[3-[(E)-2-(7-Chloroquinolin-2-yl)ethenyl]phenyl]-3-[2-(2-hydroxypropan-2-yl)phenyl]propyl]sulfanylmethyl]cyclopropyl]acetic acid

Drag to rotate. Structure from PubChem CID 5281040.

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Registration

Applicants: 24
Registrations: 100
Schedule source: Consolidated Schedules 06 July 2026

Applicants and registrations

Applicant	Brands	Dosages	Registrations	Schedule	Leaflets
Organon South Africa (Pty) Ltd1 of 12 cancelled	Singulair, Monte-air, Monte-air sprinkles, Airathon, Airathon sprinkles, Singulair sprinkles	4 mg, 5 mg, 10 mg	320321, 320322, 350397, 440059, 440060, 440061, 440062, 440666, 440667, 440668, 440669, A380584	S3	None
Dr Reddyæs Laboratories (Pty) LtdCertificate held by Dr. Reddy’s Laboratories (Pty) Ltd.	Topraz	4, 5, 10	430785, 430786, 430787	S3	PI PIL
Sandoz South Africa (Pty) LtdCertificate held by Sandoz SA (Pty) Ltd, Sandoz SA (Pty) Ltd1	Sintrine, Montelukast unicorn	4, 4.15 mg, 5, 10 mg	440203, 440204, 440485, 440486, 440487, 440488, 470742, 470743	S3	PI PIL
Trinity Pharma (Pty) Ltd	Monteflo, Lucan chew	4 mg, 5 mg, 10	440257, 440262, 440286, 450667, 450668, 560911	S3	None
Austell Pharmaceuticals (Pty) Ltd	Belair	4 mg, 5 mg, 10 mg	440431, 450744, 450745	S3	None
Ascendis Pharma (Pty) Ltd	Minair	4, 5, 10	440493, 440494, 440495	S3	None
Zydus Healthcare (Pty) Ltd	Montelukast zydus, Lumont	4 mg, 5 mg, 10 mg	440791, 440792, 440821, 440822, 440823, 440824	S3	None
Pharma Dynamics (Pty) Ltd1 of 4 cancelled	Monteil, Sintair	4 mg, 5 mg, 10 mg	440828, 440829, 440830, 440831	S3	None
Cipla Medpro (Pty) LtdCancelled	Montelukast cipla	4, 5, 10	440844, 440845, 440846	S3	None
Adcock ingram limited	Kulair, Adco montelukast chew, Montelukast adco	4 mg, 5 mg, 10 mg	440847, 440848, 440849, 450270, 450271, 450272	S3	None
Specpharm (Pty) LtdCancelled	Montelukast specpharm	4, 5, 10	440889, 440890, 440891	S3	None
Glenmark Pharmaceuticals South Africa (Pty) Ltd	Glenmont	4, 5, 10	440912, 440913, 440914	S3	None
Ranbaxy Pharmaceutical (Pty) Ltd	Dilair	4, 5, 10	450058, 450059, 450060	S3	None
LHC Pharmaceuticals (Pty) Ltd1 of 6 cancelled	Antaluko, Montelukast LHC	10mg, 10 mg/200 mg/350 mg	450455, 450456, 450457, 450458, 450459, 450460	S3	PI PIL
Biotech Laboratories (Pty) Ltd	Montelukast chew biotech, Montelukast biotech	4, 5, 10	450475, 450476, 450477	S3	PI PIL
Acino Pharma (Pty) LtdCancelled	Sinair	4 mg, 5 mg, 10 mg	450545, 450546, 450547	S3	None
Pharmacare limited û woodmead	Leutranist	4 mg, 5 mg, 10 mg	460190, 460191, 460192	S3	None
Aurogen South Africa (Pty) LtdCancelled	Skizilia	4 mg, 5 mg, 10 mg	470049, 470050, 470051	S3	None
Accord Healthcare (Pty) Ltd	Montelukast accord, Astelair	4, 5, 10 MG	470312, 470313, 470314, 470314, 470315	S3	None
Smart Pharmaceuticals (Pty) Ltd	Leukoblok	4 MG, 5 MG, 10 MG	470412, 470413, 470414	S3	None
Macleods Pharmaceuticals SA (Pty) Ltd	Maclutek	4 mg, 5 mg, 10 mg	470596, 470597, 470598	S3	None
Hetero Drugs South Africa (Pty) Ltd	Montrahet	4 mg, 5 mg	480536, 480537	S3	None
Ascend Laboratories (Pty) Ltd	Montascend, Telukem, Montelukast alkem	10 mg	530068, 530069.068, 530070.068	S3	PI PIL
Unicorn Pharmaceuticals (Pty) Ltd	Montash chew, Montash	4, 5, 10 mg	550906, 550907, 550914	S3	PI PIL

Variants

Product	Strength and form	Registration	Status	Schedule	Leaflets
Singulair 5 MG EACH CHEW TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 5,0 mg	5 mg	32032132/10.2.2/0321	Registered	S3	None
Singulair 10 MG EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 10,0 mg	10 mg	32032232/10.2.2/0322	Registered	S3	None
Singulair 4 MG EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 4,0 mg	4 mg	35039735/10.2.2/0397	Registered	S3	None
Topraz 4 EACH CHEW TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 4,0 mg	4Chewable tablet, film-coated tablet	43078543/10.2.2/0785Approved 24 November 2022	Registered	S3	PI PIL
Topraz 5 EACH CHEW TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 5,0 mg	5Chewable tablet, film-coated tablet	43078643/10.2.2/0786Approved 24 November 2022	Registered	S3	PI PIL
Topraz 10 EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 10,0 mg	10Chewable tablet, film-coated tablet	43078743/10.2.2/0787Approved 24 November 2022	Registered	S3	PI PIL
Monte-air 4 MG EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 4,0 mg	4 mg	44005944/10.2.2/0059	Registered	S3	None
Monte-air 5 MG EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 5,0 mg	5 mg	44006044/10.2.2/0060	Registered	S3	None
Monte-air 10 MG EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 10,0 mg	10 mg	44006144/10.2.2/0061	Registered	S3	None
Monte-air sprinkles EACH SACHET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 4,0 mg	Not listed	44006244/10.2.2/0062	Registered	S3	None
Sintrine 10 EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 10,0 mg	10 mgFilm-coated tablets	44020344/10.2.2/0203Approved 20 February 2025	Registered	S3	PI PIL
Montelukast unicorn 10 EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 10,0 mg	10 mgFilm-coated tablet	44020444/10.2.2/0204Approved 25 February 2025	Registered	S3	PI PIL
Monteflo 4 EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 4,0 mg	4	44025744/10.2.2/0257	Registered	S3	None
Monteflo 5 EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 5,0 mg	5	44026244/10.2.2/0262	Registered	S3	None
Monteflo 10 EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 10,0 mg	10	44028644/10.2.2/0286	Registered	S3	None
Belair 10 MG EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 10,0 mg	10 mg	44043144/10.2.2/0431	Registered	S3	None
Sintrine 4 EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 4,0 mg	4	44048544/10.2.2/0485	Registered	S3	None
Sintrine 5 EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 5,0 mg	5	44048644/10.2.2/0486	Registered	S3	None
Montelukast unicorn 4 EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 4,0 mg	4	44048744/10.2.2/0487	Registered	S3	None
Montelukast unicorn 5 EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 5,0 mg	5	44048844/10.2.2/0488	Registered	S3	None
Minair 4 EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 4,0 mg	4	44049344/10.2.2/0493	Registered	S3	None
Minair 5 EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 5,0 mg	5	44049444/10.2.2/0494	Registered	S3	None
Minair 10 EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 10,0 mg	10	44049544/10.2.2/0495	Registered	S3	None
Airathon 4 MG EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 4,0 mg	4 mg	44066644/10.2.2/0666	Registered	S3	None
Airathon 5 MG EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 5,0 mg	5 mg	44066744/10.2.2/0667	Registered	S3	None
Airathon 10 MG EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 10,0 mg	10 mg	44066844/10.2.2/0668	Registered	S3	None
Airathon sprinkles EACH PACKET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 4,0 mg	Not listed	44066944/10.2.2/0669	Cancelled	S3	None
Montelukast zydus 10 MG EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 10,0 mg	10 mg	44079144/10.2.2/0791	Registered	S3	None
Lumont 10 MG EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 10,0 mg	10 mg	44079244/10.2.2/0792	Registered	S3	None
Montelukast zydus 4 MG EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 4,0 mg	4 mg	44082144/10.2.2/0821	Registered	S3	None
Montelukast zydus 5 MG EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 5,0 mg	5 mg	44082244/102.2/0822	Registered	S3	None
Lumont 4 MG EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 4,0 mg	4 mg	44082344/10.2.2/0823	Registered	S3	None
Lumont 5 MG EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 5,0 mg	5 mg	44082444/10.2.2/0824	Registered	S3	None
Monteil 10 MG EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 10,0 mg	10 mg	44082844/10.2.2/0828	Cancelled	S3	None
Sintair 4 MG EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 4,0 mg	4 mg	44082944/10.2.2/0829	Registered	S3	None
Sintair 5 MG EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 5,0 mg	5 mg	44083044/10.2.2/0830	Registered	S3	None
Sintair 10 MG EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 10,0 mg	10 mg	44083144/10.2.2/0831	Registered	S3	None
Montelukast cipla 4 EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 4,0 mg	4	44084444/10.2.2/0844	Cancelled	S3	None
Montelukast cipla 5 EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 5,0 mg	5	44084544/10.2.2/0845	Cancelled	S3	None
Montelukast cipla 10 EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 10,0 mg	10	44084644/10.2.2/0846	Cancelled	S3	None
Kulair 4 EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 4,0 mg	4	44084744/10.2.2/0847	Registered	S3	None
Kulair 5 EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 5,0 mg	5	44084844/10.2.2/0848	Registered	S3	None
Kulair 10 EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 10,0 mg	10	44084944/10.2.2/849	Registered	S3	None
Montelukast specpharm 4 EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 4,0 mg	4	44088944/10.2.2/0889	Cancelled	S3	None
Montelukast specpharm 5 EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 5,0 mg	5	44089044/10.2.2/0890	Cancelled	S3	None
Montelukast specpharm 10 EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 10,0 mg	10	44089144/10.2.2/0891	Cancelled	S3	None
Glenmont 4 EACH TABLET CONTAINS MONTELUKAST 4,0 mg	4	44091244/10.2.2/0912	Registered	S3	None
Glenmont 5 EACH TABLET CONTAINS MONTELUKAST 5,0 mg	5	44091344/10.2.2/0913	Registered	S3	None
Glenmont 10 EACH TABLET CONTAINS MONTELUKAST 10,0 mg	10	44091444/10.2.2/0914	Registered	S3	None
Dilair 4 EACH TABLET CONTAINS: MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 4,0 mg	4	45005845/10.2.2/0058	Registered	S3	None
Dilair 5 EACH TABLET CONTAINS: MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 5,0 mg	5	45005945/10.2.2/0059	Registered	S3	None
Dilair 10 EACH TABLET CONTAINS: MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 10,0 mg	10	45006045/10.2.2/0060	Registered	S3	None
Adco montelukast 4 MG chew EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 4,0 mg	4 mg	45027045/10.2.2/0270	Registered	S3	None
Adco montelukast 5 MG chew EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 5,0 mg	5 mg	45027145/10.2.2/0271	Registered	S3	None
Montelukast adco 10 MG EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 10,0 mg	10 mg	45027245/10.2.2/0272	Registered	S3	None
Antaluko 4 Each tablet contains MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 4,0 mg	10mgFilm-coated tablets	45045545/10.2.2/0455Approved 31 January 2024	Registered	S3	PI PIL
Antaluko 5 Each tablet contains MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 5,0 mg	10mgFilm-coated tablets	45045645/10.2.2/0456Approved 31 January 2024	Registered	S3	PI PIL
Antaluko 10 EACH TABLET CONTAINS :MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 10,0 mg	10mgFilm-coated tablets	45045745/10.2.2/0457Approved 31 January 2024	Cancelled	S3	PI PIL
Montelukast 4 LHC Each tablet contains MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 4,0 mg	10 mg/200 mg/350 mgFilm-coated tablets,	45045845/10.2.2/0458Approved 31 January 2024	Registered	S3	PI PIL
Montelukast 5 LHC Each tablet contains MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 5,0 mg	10 mg/200 mg/350 mgFilm-coated tablets,	45045945/10.2.2/0459Approved 31 January 2024	Registered	S3	PI PIL
Montelukast LHC 10 EACH TABLET CONTAINS :MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 10,0 mg	10 mg/200 mg/350 mgFilm-coated tablets,	45046045/10.2.2/0460Approved 31 January 2024	Registered	S3	PI PIL
Montelukast 4 chew biotech EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 4,0 mg	4	45047545/10.2.2/0475	Registered	S3	None
Montelukast 5 chew biotech EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 5,0 mg	5	45047645/10.2.2/0476	Registered	S3	None
Montelukast 10 biotech EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 10,0 mg	10Chewable tablets	45047745/10.2.2/0477	Registered	S3	PI PIL
Sinair 4 MG EACH CHEWABLE TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 4,0 mg	4 mg	45054545/10.2.2/0545	Cancelled	S3	None
Sinair 5 MG EACH CHEWABLE TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 5,0 mg	5 mg	45054645/10.2.2/0546	Cancelled	S3	None
Sinair 10 MG EACH FILM-COATED TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 10,0 mg	10 mg	45054745/10.2.2/0547	Cancelled	S3	None
Lucan chew 4 MG EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 4,0 mg	4 mg	45066745/10.2.2/0667	Registered	S3	None
Lucan chew 5 MG EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 5,0 mg	5 mg	45066845/10.2.2/0668	Registered	S3	None
Belair 4 MG EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 4,0 mg	4 mg	45074445/10.2.2/0744	Registered	S3	None
Belair 5 MG EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 5,0 mg	5 mg	45074545/10.2.2/0745	Registered	S3	None
Leutranist 4 MG EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 4,0 mg	4 mg	46019046/10.2.2/0190	Registered	S3	None
Leutranist 5 MG EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 5,0 mg	5 mg	46019146/10.2.2/0191	Registered	S3	None
Leutranist 10 MG EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 10,0 mg	10 mg	46019246/10.2.2/0192	Registered	S3	None
Skizilia 10 MG tablets EACH TABLET CONTAINS: MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 10,0 mg	10 mgTablets	47004947/10.2.2/0049	Cancelled	S3	None
Skizilia chewable 4 MG tablets EACH TABLET CONTAINS: MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 4,0 mg	4 mgChewable tablets	47005047/10.2.2/0050	Cancelled	S3	None
Skizilia chewable 5 MG tablets EACH TABLET CONTAINS: MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 5,0 mg	5 mgChewable tablets	47005147/10.2.2/0051	Cancelled	S3	None
Montelukast 4 accord EACH TABLET CONTAINS MONTELUKAST 4,0 mg	4	47031247/10.3/0312	Registered	S3	None
Montelukast 5 accord EACH TABLET CONTAINS MONTELUKAST 5,0 mg	5	47031347/10.3/0313	Registered	S3	None
Astelair 4 EACH TABLET CONTAINS MONTELUKAST 4,0 mg	4	47031447/10.3/0315	Registered	S3	None
Montelukast 10 MG accord Each tablet contains MONTELUKAST (AS MONTELUKAST SODIUM) 10,0 mg	10 MG	47031447/10.2.2/0314	Registered	S3	None
Astelair 5 EACH TABLET CONTAINS: MONTELUKAST 5,0 mg	5	47031547/10.3/0316	Registered	S3	None
Leukoblok 4 MG Each chewable tablet contains MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 4,0 mg	4 MG	47041247/10.2.2/0412	Registered	S3	None
Leukoblok 5 MG Each chewable tablet contains MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 5,0 mg	5 MG	47041347/10.2.2/0413	Registered	S3	None
Leukoblok 10 MG Each tablet contains MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 10,0 mg	10 MG	47041447/10.2.2/0414	Registered	S3	None
Maclutek 10 MG Each tablet contains: Montelukast sodium equivalent to montelukast 10,0 mg	10 mg	47059647/10.2.2/0596	Registered	S3	None
Maclutek 4 MG chewable tablets Each Tablet contains: Montelukast 4,0 mg	4 mgChewable tablets	47059747/10.2.2/0597	Registered	S3	None
Maclutek 5 MG chewable tablets Each Tablet contains: Montelukast 5,0 mg	5 mgChewable tablets	47059847/10.2.2/0598	Registered	S3	None
Montelukast oral granules unicorn	4.15 mgOral granules.	47074247/10.3/0742Approved 20 February 2025	Registered	S3	PI PIL
Sintrine oral granules	4.15 mgOral granules.	47074347/10.3/0743Approved 20 February 2025	Registered	S3	PI PIL
Montrahet 4 MG EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 4,0 mg	4 mg	48053648/10.4.2/0536	Registered	S3	None
Montrahet 5 MG EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 5,0 mg	5 mg	48053748/10.4.2/0537	Registered	S3	None
Montascend EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 10,0 mg	10 mgTablet	53006853/10.2.2/0068Approved 20 June 2023	Registered	S3	PI PIL
Telukem EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 10,0 mg	10 mgTablet	530069.06853/10.2.2/0069.068Approved 20 June 2023	Registered	S3	PI PIL
Montelukast 10 MG alkem EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 10,0 mg	10 mgTablet	530070.06853/10.2.2/0070.068Approved 20 June 2023	Registered	S3	PI PIL
Montash 4 chew EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 4,0 mg	4	55090655/10.2.2/0906	Registered	S3	None
Montash 5 chew EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 5,0 mg	5	55090755/10.2.2/907	Registered	S3	None
Montash 10 EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 10,0 mg	10 mgTablet	55091455/10.2.2/0914Approved 17 October 2023	Registered	S3	PI PIL
Monteflo 4 MG oral granules EACH SACHET CONTAINS MONTELUKAST 4,0 mg	4 mgOral granules	56091156/10.22/0911	Registered	S3	None
Singulair sprinkles EACH 500,0 mg PACKET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 4,0 mg	Not listed	A380584A38/10.2.2/0584	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 Montelukast sodium equivalent to montelukast

S3: Montelukast
Consolidated Schedules 06 July 2026, line 3967

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 professionalsTopraz 4, Dr Reddyæs Laboratories (Pty) Ltd Patient information leaflet (PIL)For patients and carersTopraz 4, Dr Reddyæs Laboratories (Pty) Ltd

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

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