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Ranitidine (Ranitidine Biotech)

Ranitidine

Biotech Laboratories (Pty) Ltd

Registration

Applicant
Biotech Laboratories (Pty) Ltd
Registrations
2

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Ranitidine biotech 150

EACH TABLET CONTAINS RANITIDINE HYDROCHLORIDE EQUIVALENT TO RANITIDINE 150,0 mg

15031067331/11.4.3/0673RegisteredNot determinedNone
Ranitidine biotech 300

EACH TABLET CONTAINS RANITIDINE HYDROCHLORIDE EQUIVALENT TO RANITIDINE 300,0 mg

30031067431/11.4.3/0674RegisteredNot determinedNone

Regulatory status

This product is still scheduled by law even when this site could not determine which tier it falls under. The label carries the S number in a square border; ask a pharmacist if you need to know its schedule.

Listings for this ingredient that could not be applied to this product

  • S3: Ranitidine

    • except where administered orally for short-term symptomatic relief of heartburn and hyperacidity, subject to a maximum dose of 75 milligrams, a maximum daily dose of 300 milligrams and a maximum treatment period of two weeks. (S2)

    Consolidated Schedules 06 July 2026, lines 4205 to 4207

  • S2: Ranitidine

    • when administered orally for short-term symptomatic relief of heartburn and hyperacidity, subject to -
    • a maximum dose of 75 milligrams;
    • a maximum daily dose of 300 milligrams;
    • a maximum treatment period of two weeks. (S3)

    Consolidated Schedules 06 July 2026, lines 2625 to 2632

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.

C13H22N4O3S314.41 g/mol

(E)-1-N'-[2-[[5-[(Dimethylamino)methyl]furan-2-yl]methylsulfanyl]ethyl]-1-N-methyl-2-nitroethene-1,1-diamine

Drag to rotate. Structure from PubChem CID 3001055.

SAHPRA documents

SAHPRA has not published a professional information or patient information leaflet for this product.

Background

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Research articles

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