Nicotinic acid
Sold as Niaspan, Tempo, Nicotinic acid
Background
Registration
- Applicants
- 2
- Registrations
- 7
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Abbott Laboratories S.A. (Pty) Ltd | Niaspan | 375mg, 500 mg, 750 mg, 1000 mg | A390245, A390246, A390247, A390248 | Not determined | None |
| The Premier Pharmaceutical Co LtdCancelled | Tempo, Nicotinic acid | tablets, 50MG, 100 MG | H0320, H0545, H0551 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Niaspan 375mg EACH TABLET CONTAINS NICOTINIC ACID 375,0 mg | 375mg | A390245A39/7.5/0245 | Registered | Not determined | None |
| Niaspan 500 MG EACH TABLET CONTAINS NICOTINIC ACID 500,0 mg | 500 mg | A390246A39/7.5/0246 | Registered | Not determined | None |
| Niaspan 750 MG EACH TABLET CONTAINS NICOTINIC ACID 750,0 mg | 750 mg | A390247A39/7.5/0247 | Registered | Not determined | None |
| Niaspan 1000 MG EACH TABLET CONTAINS NICOTINIC ACID 1000,0 mg | 1000 mg | A390248A39/7.5/0248 | Registered | Not determined | None |
| Tempo tablets* EACH TABLET CONTAINS NICOTINIC ACID 100 mg | Tablets | H0320H/22/320 | Cancelled | Not determined | None |
| Nicotinic acid 100 MG EACH TABLET CONTAINS NICOTINIC ACID A 100 MG | 100 MG | H0545 | Cancelled | Not determined | None |
| Nicotinic acid 50mg EACH TABLET CONTAINS NICOTINIC ACID A 50 MG | 50MG | H0551 | Cancelled | Not determined | None |
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
S4: Niacin
- when intended for hypercholesterolaemia and for the management of dyslipidaemias; (S0)
- except in oral preparations or mixtures containing more than 35 mg of Niacin per recommended daily dose alone or in combination with other active pharmaceutical ingredients. (S1)
Consolidated Schedules 06 July 2026, lines 7247 to 7252
S1: Niacin
- in oral preparations or mixtures containing more than 35 mg of Niacin per recommended daily dose alone or in combination with other active pharmaceutical ingredients; (S0)
- except when intended for hypercholesterolaemia and for the management of dyslipidaemias. (S4)
Consolidated Schedules 06 July 2026, lines 879 to 884
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
SAHPRA has not published a professional information or patient information leaflet for this product.