Labetalol
Sold as Aspen labetalol, Adco labetalol, Labetalol RBC, Trandate
2-Hydroxy-5-[1-hydroxy-2-(4-phenylbutan-2-ylamino)ethyl]benzamide
Drag to rotate. Structure from PubChem CID 3869.
Background
Registration
- Applicants
- 3
- Registrations
- 5
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Pharmacare limited û woodmeadCertificate held by Pharmacare limited | Aspen labetalol, Trandate | 5 mg/ml, 100 mg | 420519, J0052, J0054 | S3 | PIPIL |
| Adcock Ingram Critical Care (Pty) Ltd | Adco labetalol | 5 mg/ml | 430661 | S3 | PIPIL |
| RBC Pharmaceuticals (Pty) Ltd | Labetalol RBC | 5 mg | 570906 | S3 | PIPIL |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Aspen labetalol EACH 1,0 ml SOLUTION CONTAINS LABETALOL HYDROCHLORIDE 5,0 mg | Not listed | 42051942/7.1.3/0519 | Registered | S3 | None |
| Adco labetalol 5 mg/ml EACH 1,0 ml CONTAINS: LABETALOL HYDROCHLORIDE 5,0 mg | 5 mg/mlSolution for injection | 43066143/7.1.3/0661Approved 20 May 2025 | Registered | S3 | PIPIL |
| Labetalol 5 mg/ml RBC EACH 1,0 ml SOLUTION CONTAINS: LABETALOL HYDROCHLORIDE 5,0 mg | 5 mgInjection | 57090657/7.1.3/0906Approved 30 September 2025 | Registered | S3 | PIPIL |
| Trandate tablets 100 MG EACH TABLET CONTAINS LABETALOL HYDROCHLORIDE 100 mg | 100 mgTablets | J0052J/7.1.3/52 | Registered | S3 | None |
| Trandate injection EACH 1 ml SOLUTION CONTAINS LABETALOL HYDROCHLORIDE 5 mg | 5 mg/mlInjection | J0054J/7.1.3/54Approved 25 April 2024 | 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 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 Labetalol hydrochloride
S3: Labetalol
Consolidated Schedules 06 July 2026, line 3862
Pharmacological class: Other hypotensives. (class 7.1.3)
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 Verification
Adco labetalol 5 mg/ml, Adcock Ingram Critical Care (Pty) Ltd is scheduled S3 in its official SAHPRA documents, read with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.