Amiodarone

Sold as Arycor, Hexarone, Bio-amiodarone, Amiotach, Amiodarone iv biotech, Amiodarone iv activo, Amiodarone accord, Myorythm, Amizyd, Azyron, Amiodarone PHARMC, Rathmicor, Amiodarone oethmaan, Sabax amiodarone, Adcorone, Cordarone x, Cordarone x intravenous

C₂₅H₂₉I₂NO₃645.30 g/mol

(2-Butyl-1-benzofuran-3-yl)-[4-[2-(diethylamino)ethoxy]-3,5-diiodophenyl]methanone

Drag to rotate. Structure from PubChem CID 2157.

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Registration

Applicants: 15
Registrations: 23
Schedule source: Consolidated Schedules 06 July 2026

Applicants and registrations

Applicant	Brands	Dosages	Registrations	Schedule	Leaflets
Sanofi-aventis South Africa (Pty) Ltd1 of 3 cancelled	Arycor, Cordarone x	100, 150mg/3ml, 200	320513, 320514, P0165	S4	PI PIL
Sandoz South Africa (Pty) Ltd	Hexarone	100, 200	320650, 320651	S4	None
Biotech Laboratories (Pty) Ltd	Bio-amiodarone, Amiodarone iv biotech	50, 200 mg	340119, 440189	S4	PI PIL
Pharmacare limited û woodmeadCancelled	Amiotach	Not stated	420035	S4	None
Activo Health (Pty) Ltd	Amiodarone iv activo	Not stated	530332	S4	None
Accord Healthcare (Pty) Ltd	Amiodarone accord	30 mg	550465	S4	PI PIL
Ipharma (Pty) Ltd	Myorythm	100, 200	560549, 560550	S4	PI PIL
Zydus Healthcare (Pty) Ltd	Amizyd, Azyron	100, 200	580097, 580098, 580099, 580100.098	S4	None
Pharmacorp (Pty) Ltd	Amiodarone PHARMC	150 mg/3 ml	590008	S4	None
Austell Pharmaceuticals (Pty) Ltd	Rathmicor	150 mg/3 ml	590127	S4	None
Hexal Pharma (SA) (Pty) LtdCancelled	Hexarone	150 mg/3 ml	A390155	S4	None
Oethmaan Biosims (Pty) Ltd	Amiodarone oethmaan	150 mg/3 ml	A390156	S4	None
Adcock Ingram Critical Care (Pty) Ltd	Sabax amiodarone	150 mg/3 ML	A390319	S4	None
Adcock ingram limited	Adcorone	Not stated	A390321	S4	None
Sanofi Industries South Africa (Pty) Ltd	Cordarone x intravenous	Not stated	S0384	S4	None

Variants

Product	Strength and form	Registration	Status	Schedule	Leaflets
Arycor 100 EACH TABLET CONTAINS AMIODARONE HYDROCHLORIDE 100,0 mg	100	32051332/6.2/0513	Registered	S4	None
Arycor 200 EACH TABLET CONTAINS AMIODARONE HYDROCHLORIDE 200,0 mg	200	32051432/6.2/0514	Registered	S4	None
Hexarone 100 EACH TABLET CONTAINS AMIODARONE HYDROCHLORIDE 100,0 mg	100	32065032/6.2/0650	Registered	S4	None
Hexarone 200 EACH TABLET CONTAINS AMIODARONE HYDROCHLORIDE 200,0 mg	200	32065132/6.2/0651	Registered	S4	None
Bio-amiodarone EACH TABLET CONTAINS AMIODARONE HYDROCHLORIDE 200,0 mg	200 mgTablets.	34011934/6.2/0119Approved 15 March 2023	Registered	S4	PI PIL
Amiotach EACH 3,0 ml SOLUTION CONTAINS AMIODARONE HYDROCHLORIDE 150,0 mg	Not listed	42003542/6.2/0035	Cancelled	S4	None
Amiodarone 50 iv biotech EACH 1,0 ml SOLUTION CONTAINS AMIODARONE HYDROCHLORIDE 50,0 mg	50	44018944/6.2/0189	Registered	S4	None
Amiodarone iv activo EACH AMPOULE CONTAINS AMIODARONE HYDROCHLORIDE 150,0 mg	Not listed	53033253/6.2/0332	Registered	S4	None
Amiodarone 30 mg/ml prefilled syringe accord EACH 1,0 ml SOLUTION CONTAINS AMIODARONE 30,0 mg	30 mgSolution for injection/infusion in a pre-filled syringe	55046555/6.2/0465Approved 6 June 2023	Registered	S4	PI PIL
Myorythm 100 EACH TABLET CONTAINS AMIODARONE HYDROCHLORIDE 100 mg	100Tablets.	56054956/6.2/0549Approved 6 June 2023	Registered	S4	PI PIL
Myorythm 200 EACH TABLET CONTAINS AMIODARONE HYDROCHLORIDE 200 mg	200Tablets.	56055056/6.2/0550Approved 6 June 2023	Registered	S4	PI PIL
Amizyd 100 EACH TABLET CONTAINS: AMIODARONE HYDROCHLORIDE 100,0 mg	100	58009758/6.2/0097	Registered	S4	None
Amizyd 200 EACH TABLET CONTAINS: AMIODARONE HYDROCHLORIDE 200,0 mg	200	58009858/6.2/0098	Registered	S4	None
Azyron 100 EACH TABLET CONTAINS: AMIODARONE HYDROCHLORIDE 100,0 mg	100	58009958/6.2/0099.097	Registered	S4	None
Azyron 200 EACH TABLET CONTAINS: AMIODARONE HYDROCHLORIDE 200,0 mg	200	580100.09858/6.2/0100.098	Registered	S4	None
Amiodarone 150 mg/3 ML PHARMC EACH AMPOULE CONTAINS: AMIODARONE HYDROCHLORIDE 150,0 mg	150 mg/3 ml	59000859/6.2/0008	Registered	S4	None
Rathmicor 150 mg/3 ML EACH AMPOULE CONTAINS: AMIODARONE HYDROCHLORIDE 150,0 mg	150 mg/3 ml	59012759/6.2/0127	Registered	S4	None
Hexarone 150 mg/3 ML EACH 3,0 ml SOLUTION CONTAINS AMIODARONE HYDROCHLORIDE 150,0 mg	150 mg/3 ml	A390155A39/6.2/0155	Cancelled	S4	None
Amiodarone 150 mg/3 ML oethmaan EACH 3,0 ml SOLUTION CONTAINS AMIODARONE HYDROCHLORIDE 150,0 mg	150 mg/3 ml	A390156A39/6.2/0156	Registered	S4	None
Sabax amiodarone 150 mg/3 ML each 3,0 ML solution CONTAINS AMIODARONE HYDROCHLORIDE 150,0 mg	150 mg/3 ML	A390319A39/6.2/0319	Registered	S4	None
Adcorone EACH 3,0 ml SOLUTION CONTAINS AMIODARONE HYDROCHLORIDE 150,0 mg	Not listed	A390321A39/6.2/0321	Registered	S4	None
Cordarone x 200 EACH TABLET CONTAINS AMIODARONE HYDROCHLORIDE 200 mg	150mg/3mlInjection	P0165P/6.2/165Approved 12 April 2021	Cancelled	S4	PI PIL
Cordarone x intravenous EACH 3 ml SOLUTION CONTAINS: AMIODARONE HYDROCHLORIDE 150 mg	Not listed	S0384S/6.2/384	Registered	S4	None

Regulatory status

Where S4 sits on the scale

S0S1S2S3S4S5S6S7S8

Prescription-only medicine.

Schedule 4 covers most ordinary prescription medicines. You need a prescription from an authorised prescriber, such as a doctor or dentist, and a pharmacist dispenses it. 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 S4, 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 Amiodarone hydrochloride

S4: Amiodarone
Consolidated Schedules 06 July 2026, line 5230

Pharmacological class: Cardiac depressants. (class 6.2)

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 verified from official documents

Schedule Verification

Bio-amiodarone, Biotech Laboratories (Pty) Ltd is scheduled S4 in its official SAHPRA documents, read with 90% confidence.

Professional information (PI)For healthcare professionalsBio-amiodarone, Biotech Laboratories (Pty) Ltd Patient information leaflet (PIL)For patients and carersBio-amiodarone, Biotech Laboratories (Pty) Ltd

These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.

Research articles

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