Nalbuphine
Sold as Lanphi, Nalbain, Nalbuphine hydrochloride dihydrate equivalent to nalbuphine hydrochloride anhydrous, Nalbuphine hydrochloride ascendis
4-Amino-1-[(2R,3E,4S,5R)-3-(fluoromethylidene)-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]pyrimidin-2-one
Drag to rotate. Structure from PubChem CID 6435808.
Background
Registration
- Applicants
- 3
- Registrations
- 6
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Adcock Ingram Critical Care (Pty) Ltd | Lanphi | 10 MG/ML, 20 MG/ML | 510195, 521014 | S5 | None |
| Arya Pharma (Pty) Ltd | Nalbain | 10 MG/ML, 20 MG/ML | 510360, 510362 | S5 | None |
| Ascendis Pharma (Pty) Ltd | Nalbuphine hydrochloride dihydrate equivalent to nalbuphine hydrochloride anhydrous, Nalbuphine hydrochloride ascendis | 10,0 mg, 20 MG/ML | 510361.36, 510363.362 | S5 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Lanphi 20 mg/ml Each ampoule contains NALBUPHINE HYDROCHLORIDE DIHYDRATE EQUIVALENT TO NALBUPHINE HYDROCHLORIDE ANHYDROUS 20,0 mg | 20 MG/ML | 51019551/2.9/0195 | Registered | S5 | None |
| Nalbain injection 10 mg/ml Each 1,0 ml contains NALBUPHINE HYDROCHLORIDE DIHYDRATE EQUIVALENT TO NALBUPHINE HYDROCHLORIDE ANHYDROUS 10.0 mg | 10 MG/MLInjection | 51036051/2.9/0360 | Registered | S5 | None |
| Nalbuphine hydrochloride dihydrate equivalent to nalbuphine hydrochloride anhydrous 10,0 MG Each 1,0 ml contains NALBUPHINE HYDROCHLORIDE DIHYDRATE EQUIVALENT TO NALBUPHINE HYDROCHLORIDE ANHYDROUS 10.0 mg | 10,0 mg | 510361.3651/2.9/0361.360 | Registered | S5 | None |
| Nalbain injection 20 mg/ml Each 1,0 ml contains NALBUPHINE HYDROCHLORIDE DIHYDRATE EQUIVALENT TO NALBUPHINE HYDROCHLORIDE ANHYDROUS 20.0 mg | 20 MG/MLInjection | 51036251/2.9/0362 | Registered | S5 | None |
| Nalbuphine hydrochloride injection 20 mg/ml ascendis Each 1,0 ml contains NALBUPHINE HYDROCHLORIDE DIHYDRATE EQUIVALENT TO NALBUPHINE HYDROCHLORIDE ANHYDROUS 20.0 mg | 20 MG/MLInjection | 510363.36251/2.9/0363.362 | Registered | S5 | None |
| Lanphi 10 mg/ml Each ampoule contains NALBUPHINE HYDROCHLORIDE DIHYDRATE EQUIVALENT TO NALBUPHINE HYDROCHLORIDE ANHYDROUS 10,0 mg | 10 MG/ML | 52101452/2.9/1014 | Registered | S5 | None |
Regulatory status
Where S5 sits on the scale
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 Nalbuphine hydrochloride dihydrate equivalent to nalbuphine hydrochloride anhydrous
S5: Nalbuphine
Consolidated Schedules 06 July 2026, line 9578
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
SAHPRA has not published a professional information or patient information leaflet for this product.