Isosorbide dinitrate
Sold as Aspen isosorbide dinitrate, Apo-isosorbide dinitrate, Dinospray, Cedocard, Isordil sublingual, Isordil, Isordil tembids, Angi-, Isosorbide dinitrate kiara, Sosorbide dinitrate kiara, Isoket
[(3S,3AS,6R,6aS)-3-nitrooxy-2,3,3a,5,6,6a-hexahydrofuro[3,2-b]furan-6-yl] nitrate
Drag to rotate. Structure from PubChem CID 6883.
Background
Registration
- Applicants
- 6
- Registrations
- 13
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Pharmacare limited û woodmead3 of 5 cancelled | Aspen isosorbide dinitrate, Apo-isosorbide dinitrate, Isordil, Angi- | 10 mg, 30 mg, angi-spray | 320014, 320015, H0603, L0027, S0318 | S3 | None |
| Cipla Medpro (Pty) LtdCancelled | Dinospray | Not stated | 340377 | S3 | None |
| Byk Madaus (Pty) LtdCancelled | Cedocard | 5 mg | E0146 | S3 | None |
| Akromed Products (Pty) Ltd | Isordil sublingual, Isordil tembids | 5 MG, 40 MG | H0602, H0604 | S3 | None |
| Kiara Health (Pty) Ltd | Isosorbide dinitrate kiara, Sosorbide dinitrate kiara | 5, 10, 30 | V0358, V0359, W0336 | S3 | None |
| Glaxosmithkline South Africa (Pty) LimitedCertificate held by Glaxosmithkline South Africa (Pty) Ltd | Isoket | 1 mg/1 mL | W0360 | S3 | PIPIL |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Aspen isosorbide dinitrate 10 MG EACH TABLET CONTAINS ISOSORBIDE DINITRATE 10,0 mg | 10 mg | 32001432/7.1.4/0014 | Cancelled | S3 | None |
| Apo-isosorbide dinitrate 30 MG EACH TABLET CONTAINS ISOSORBIDE DINITRATE 30,0 mg | 30 mg | 32001532/7.1.4/0015 | Cancelled | S3 | None |
| Dinospray EACH ACTUATION OF 0,1 ml SOLUTION CONTAINS ISOSORBIDE DINITRATE 1,25 mg | Not listed | 34037734/7.1.4/0377 | Cancelled | S3 | None |
| Cedocard 5 MG EACH TABLET CONTAINS ISOSORBIDE DINITRATE 5 mg | 5 mg | E0146E/7.1.4/146 | Cancelled | S3 | None |
| Isordil sublingual tablets 5 MG EACH TABLET CONTAINS ISOSORBIDE DINITRATE A 5,0 mg | 5 MGTablets | H0602 | Old Medicine | S3 | None |
| Isordil tablets 10 MG EACH TABLET CONTAINS ISOSORBIDE DINITRATE A 10,0 mg | 10 MGTablets | H0603 | Old Medicine | S3 | None |
| Isordil tembids tablets 40 MG EACH TABLET CONTAINS ISOSORBIDE DINITRATE A 40,0 mg | 40 MGTablets | H0604 | Old Medicine | S3 | None |
| Isordil 30 MG EACH TABLET CONTAINS ISOSORBIDE DINITRATE 30 mg | 30 mg | L0027L/7.1.4/0027 | Registered | S3 | None |
| Angi-spray EACH 0,09 ml CONTAINS ISOSORBIDE DINITRATE 1,25 mg | Angi-spray | S0318S/7.1.4/318 | Cancelled | S3 | None |
| Isosorbide dinitrate 10 kiara EACH TABLET CONTAINS ISOSORBIDE DINITRATE 10 mg | 10 | V0358V/7.1.4/358 | Registered | S3 | None |
| Sosorbide dinitrate 30 kiara EACH TABLET CONTAINS ISOSORBIDE DINITRATE 30 mg | 30 | V0359V/7.1.4/359 | Registered | S3 | None |
| Isosorbide dinitrate 5 kiara EACH TABLET CONTAINS ISOSORBIDE DINITRATE 5 mg | 5 | W0336W/7.1.4/336 | Registered | S3 | None |
| Isoket 0,1 % solution EACH 10 ml INFUSION SOLUTION CONTAINS ISOSORBIDE DINITRATE 10 mg | 1 mg/1 mLSolution for infusion | W0360W/7.1.4/360Approved 5 September 2021 | Registered | S3 | PIPIL |
Regulatory status
Where S3 sits on the scale
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 medium.
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 Isosorbide dinitrate
S3: Isosorbide
Consolidated Schedules 06 July 2026, line 3824
Pharmacological class: Vasodilators - coronary and other medicines used in angina pectoris. (class 7.1.4)
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
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.