Tramadol

Sold as Nobligan, Tramal sr, Tramahexal, Dolotram, Domadol, Tramahexal sr, Tramgesic flashtabs, Tramaspen, Tramadol zydus sr, Oztrak, Tramadol sr austell, Tramadol unimed, Zytram, Tramadol sr biotech, Tramadolacet sr, Epstell, Tramazac, Sabax tramadol, Tramadol austell, Tramal

C₁₆H₂₅NO₂263.37 g/mol

cis-(1R,2R)-2-[(Dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexan-1-ol

Drag to rotate. Structure from PubChem CID 33741.

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Registration

Applicants: 15
Registrations: 39
Schedule source: Consolidated Schedules 06 July 2026

Applicants and registrations

Applicant	Brands	Dosages	Registrations	Schedule	Leaflets
Janssen Pharmaceutica (Pty) LtdCertificate held by Janssen pharmaceutica	Nobligan, Tramal sr, Tramal	50 mg, 50mg, 100 mg, 150 mg	310048, 310646, 310647, 420283, S0289, S0290	S5	PI PIL
Sandoz South Africa (Pty) Ltd1 of 3 cancelled	Tramahexal, Tramahexal sr	capsules, 100 mg/2 ml, 150	320652, 360397, 380093	S5	None
Ranbaxy Pharmaceutical (Pty) LtdCertificate held by Ranbaxy Pharmaceuticals (Pty) Ltd	Dolotram	50 mg/100 mg, 50 mg	360337, 360338, 370532	S5S4 to S5 by pack	PI PIL
Unichem SA (Pty) Ltd	Domadol	50 mg, 100 mg	370596, A400190, A400191	S5	None
Hexal Pharma (SA) (Pty) Ltd	Tramahexal sr	100, 200	380092, 380094	S5	None
Adcock ingram limited	Tramgesic flashtabs	Not stated	380274	S5	None
Pharmacare limited û woodmead1 of 2 cancelled	Tramaspen	50 mg, 100 mg/2 ml	420967, A400220	S5	None
Zydus Healthcare (Pty) LtdCertificate held by Zydus Healthcare SA (Pty) Ltd	Tramadol zydus sr, Tramazac	50 mg, 100, 100 mg/2 ml, 150, 200	440496, 440497, 440498, A390318, A390415	S5	PI PIL
Oethmaan Biosims (Pty) Ltd	Oztrak	37.5/325	471054	S5	PI PIL
Austell Pharmaceuticals (Pty) Ltd	Tramadol sr austell, Tramadol austell	50 mg, 100	500163, A400388	S5	None
Unimed Healthcare (Pty) Ltd	Tramadol unimed	50 mg	500401	S5	PI PIL
Mundipharma (Pty) Ltd	Zytram	150 mg, 200 mg, 300 mg, 400 mg	540483, 540484, 540485, 540486	S5	None
Biotech Laboratories (Pty) Ltd	Tramadol sr biotech, Tramadolacet sr	100, 200	560248, 560249, 560250.248, 560251.249	S5	None
Dezzo Trading 392 (Pty) Ltd	Epstell	50 mg	561059	S5	PI PIL
Adcock Ingram Critical Care (Pty) LtdCancelled	Sabax tramadol	100 mg/2 ml	A400355	S5	None

Variants

Product	Strength and form	Registration	Status	Schedule	Leaflets
Nobligan 100 EACH 2 ml SOLUTION CONTAINS TRAMADOL HYDROCHLORIDE 100,0 mg	100	31004831/2.9/0048	Registered	S5	None
Tramal sr 100 MG EACH TABLET CONTAINS TRAMADOL HYDROCHLORIDE 100,0 mg	100 mg	31064631/2.9/0646	Registered	S5	None
Tramal sr 150 MG EACH TABLET CONTAINS TRAMADOL HYDROCHLORIDE 150,0 mg	150 mg	31064731/2.9/0647	Registered	S5	None
Tramahexal capsules EACH CAPSULE CONTAINS TRAMADOL HYDROCHLORIDE 50,0 mg	Capsules	32065232/2.9/0652	Registered	S5	None
Dolotram 50 EACH 1,0 ml SOLUTION CONTAINS: TRAMADOL HYDROCHLORIDE 50,0 mg	50 mg/100 mgInjection	36033736/2.9/0337Approved 24 January 2025	Registered	S5	PI PIL
Dolotram 100 EACH 2,0 ml SOLUTION CONTAINS:TRAMADOL HYDROCHLORIDE 100,0 mg	50 mg/100 mgInjection	36033836/2.9/0338Approved 24 January 2025	Registered	S5	PI PIL
Tramahexal 100 mg/2 ML EACH 2,0 ml AMPOULE CONTAINS TRAMADOL HYDROCHLORIDE 100,0 mg	100 mg/2 ml	36039736/2.9/0397	Cancelled	S5	None
Dolotram capsules EACH CAPSULE CONTAINS: TRAMADOL HYDROCHLORIDE 50,0 mg	50 mgCapsules.	37053237/2.9/0532Approved 13 May 2025	Registered	S4	PI PIL
Domadol EACH CAPSULE CONTAINS TRAMADOL HYDROCHLORIDE 50,0 mg	Not listed	37059637/2.9/0596	Registered	S5	None
Tramahexal sr 100 EACH TABLET CONTAINS TRAMADOL HYDROCHLORIDE 100,0 mg	100	38009238/2.9/0092	Registered	S5	None
Tramahexal sr 150 EACH TABLET CONTAINS TRAMADOL HYDROCHLORIDE 150,0 mg	150	38009338/2.9/0093	Registered	S5	None
Tramahexal sr 200 EACH TABLET CONTAINS TRAMADOL HYDROCHLORIDE 200,0 mg	200	38009438/2.9/0094	Registered	S5	None
Tramgesic flashtabs EACH TABLET CONTAINS TRAMADOL HYDROCHLORIDE 50,0 mg	Not listed	38027438/2.9/0274	Registered	S5	None
Tramal sr 50 MG EACH TABLET CONTAINS TRAMADOL HYDROCHLORIDE 50,0 mg	50 mg	42028342/2.9/0283	Registered	S5	None
Tramaspen 50 MG EACH CAPSULE CONTAINS TRAMADOL HYDROCHLORIDE 50,0 mg	50 mg	42096742/2.9/0967	Registered	S5	None
Tramadol zydus sr 100 tablets EACH TABLET CONTAINS TRAMADOL HYDROCHLORIDE 100,0 mg	100Tablets	44049644/2.9/0496	Registered	S5	None
Tramadol zydus sr 150 tablets EACH TABLET CONTAINS TRAMADOL HYDROCHLORIDE 150,0 mg	150Tablets	44049744/2.9/0497	Registered	S5	None
Tramadol zydus sr 200 tablets EACH TABLET CONTAINS TRAMADOL HYDROCHLORIDE 200,0 mg	200Tablets	44049844/2.9/0498	Registered	S5	None
Oztrak 37.5/325 Each Film coated Tablet contains: Tramadol Hydrochloride 37,5 mg, Paracetamol	37.5/325Film-coated tablets	47105447/2.9/1054Approved 16 August 2023	Registered	S5	PI PIL
Tramadol sr 100 austell Each Sustained Release film coated Tablet contains: Tramadol Hydrochloride 100,0 mg	100	50016350/2.9/0163	Registered	S5	None
Tramadol unimed	50 mgCapsules	50040150/2.9/0401Approved 21 February 2025	Registered	S5	PI PIL
Zytram 150 MG EACH TABLET CONTAINS TRAMADOL HYDROCHLORIDE 150,0 mg	150 mg	54048354/2.9/0483	Registered	S5	None
Zytram 200 MG EACH TABLET CONTAINS TRAMADOL HYDROCHLORIDE 200,0 mg	200 mg	54048454/2.9/0484	Registered	S5	None
Zytram 300 MG EACH TABLET CONTAINS TRAMADOL HYDROCHLORIDE 300,0 mg	300 mg	54048554/2.9/0485	Registrered	S5	None
Zytram 400 MG EACH TABLET CONTAINS TRAMADOL HYDROCHLORIDE 400,0 mg	400 mg	54048654/2.9/0486	Registrered	S5	None
Tramadol 100 sr biotech EACH TABLET CONTAINS TRAMADOL HYDROCHLORIDE 100,0 mg	100	56024856/2.9/0248	Registered	S5	None
Tramadol 200 sr biotech EACH TABLET CONTAINS TRAMADOL HYDROCHLORIDE 200,0 mg	200	56024956/2.9/0249	Registered	S5	None
Tramadolacet 100 sr EACH TABLET CONTAINS TRAMADOL HYDROCHLORIDE 100,0 mg	100	560250.24856/2.9/0250.248	Registered	S5	None
Tramadolacet 200 sr EACH TABLET CONTAINS TRAMADOL HYDROCHLORIDE 200,0 mg	200	560251.24956/2.9/051.249	Registered	S5	None
Epstell EACH CAPSULE CONTAINS TRAMADOL HYDROCHLORIDE 50,0 mg	50 mgCapsule	56105951/2.9/1059Approved 11 October 2022	Registered	S5	PI PIL
Tramazac injection 100 mg/2 ML EACH 2,0 ml AMPOULE CONTAINS TRAMADOL HYDROCHLORIDE 100,0 mg	100 mg/2 mlInjection	A390318A39/2.9/0318	Registered	S5	None
Tramazac 50 EACH CAPSULE CONTAINS TRAMADOL HYDROCHLORIDE 50,0 mg	50 mgCapsules	A390415A39/2.9/0415Approved 21 February 2023	Registered	S5	PI PIL
Domadol 50 MG EACH AMPOULE CONTAINS TRAMADOL HYDROCHLORIDE 50,0 mg	50 mg	A400190A40/2.9/0190	Registered	S5	None
Domadol 100 MG EACH AMPOULE CONTAINS TRAMADOL HYDROCHLORIDE 100,0 mg	100 mg	A400191A40/2.9/0191	Registered	S5	None
Tramaspen 100 mg/2 ML EACH 2,0 ml SOLUTION CONTAINS TRAMADOL HYDROCHLORIDE 100,0 mg	100 mg/2 ml	A400220A40/2.9/0220	Cancelled	S5	None
Sabax tramadol 100 mg/2 ML EACH 2,0 ml AMPOULE CONTAINS TRAMADOL HYDROCHLORIDE 100,0 mg	100 mg/2 ml	A400355A40/2.9/0355	Cancelled	S5	None
Tramadol 50 MG austell EACH CAPSULE CONTAINS :TRAMADOL HYDROCHLORIDE 50,0 mg	50 mg	A400388A40/2.9/0388	Registered	S5	None
Tramal capsules EACH CAPSULE CONTAINS TRAMADOL HYDROCHLORIDE 50 mg	50 mg.Capsules	S0289S/2.9/289Approved 15 July 2021	Registered	S5	PI PIL
Tramal 100 EACH AMPOULE CONTAINS TRAMADOL HYDROCHLORIDE 100 mg	50mgCapsules	S0290S/2.0/290Approved 4 August 2017	Registered	S5	PI PIL

Regulatory status

Where S5 sits on the scale

S0S1S2S3S4S5S6S7S8

Prescription-only, with tighter controls on repeats.

Schedule 5 medicines need a prescription, and repeat dispensing is capped at six months in total; the prescriber must state upfront how many times, and at what intervals, it may be repeated. Extra limits apply to some uses: if it is being used for its anxiolytic, antidepressant, tranquillising or analgesic properties, it cannot be prescribed for longer than six months without a further consultation. 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 S5, 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.

Consolidated Schedules listings for Tramadol hydrochloride

S5: Tramadol
Consolidated Schedules 06 July 2026, line 9725

Pharmacological class: Other analgesics. (class 2.9)

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 verified from official documents

Schedule Verification

Dolotram 50, Ranbaxy Pharmaceutical (Pty) Ltd is scheduled S5 in its official SAHPRA documents, read with 90% confidence.

Professional information (PI)For healthcare professionalsDolotram 50, Ranbaxy Pharmaceutical (Pty) Ltd Patient information leaflet (PIL)For patients and carersDolotram 50, Ranbaxy Pharmaceutical (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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