Bicalutamide

Sold as Casodex, Mylan bicalutamide, Xixia-bicalutamide, Bicalox, Adco-bical, Caloxa, Accord-bicalutamide, Anandroca, Spec-bicalutamide, Bicalutamide teva, Tasdiam, Bicalutamide accord, Bicalutamide AURO, Bicadex

S4Read from the PI-PIL document and verified

C₁₈H₁₄F₄N₂O₄S430.40 g/mol

N-[4-Cyano-3-(trifluoromethyl)phenyl]-3-(4-fluorophenyl)sulfonyl-2-hydroxy-2-methylpropanamide

Drag to rotate. Structure from PubChem CID 2375.

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Registration

Applicants: 11
Registrations: 20
Schedule source: SAHPRA documentation

Applicants and registrations

Applicant	Brands	Dosages	Registrations	Schedule	Leaflets
Astrazeneca Pharmaceuticals (Pty) LtdCertificate held by Astrazeneca	Casodex	50mg, 150mg	300012, 330081	S4	PI PIL
Viatris South Africa (Pty) Ltd1 of 2 cancelled	Mylan bicalutamide, Xixia-bicalutamide	50	410703, 410745	S4	None
Acino Pharma (Pty) Ltd	Bicalox	50 mg	410818	S4	None
Adcock Ingram Critical Care (Pty) Ltd	Adco-bical	50 mg, 150 mg	410904, 410905	S4	None
Eurolab (Pty) Ltd	Caloxa, Tasdiam	50 mg, 150	420430, 441022, 441023	S4	None
Accord Healthcare (Pty) Ltd	Accord-bicalutamide, Bicalutamide accord	150mg	420431, 540880	S4	PI PIL
Zydus Healthcare (Pty) Ltd	Anandroca	50	420804	S4	None
Specpharm (Pty) Ltd	Spec-bicalutamide	50, 150	430402, 430620	S4	None
Teva Pharmaceuticals (Pty) Ltd	Bicalutamide teva	50, 150	430764, 430765	S4	None
Aurogen South Africa (Pty) LtdCertificate held by Aurogen SA (Pty) Ltd	Bicalutamide AURO	50 mg, 150 mg	590748, 590749	S4	PI PIL
Cipla Medpro (Pty) Ltd	Bicadex	Not stated	A400304	S4	None

Variants

Product	Strength and form	Registration	Status	Schedule	Leaflets
Casodex 50 EACH TABLET CONTAINS BICALUTAMIDE 50 mg	50mgTablet	30001230/21.12/0012Approved 17 February 2017	Registered	S4	PI PIL
Casodex 150 EACH TABLET CONTAINS BICALUTAMIDE 150,0 mg	150mgTablet	33008133/21.12/0081Approved 17 February 2017	Registered	S4	PI PIL
Mylan bicalutamide 50 EACH TABLET CONTAINS: BICALUTAMIDE 50,0 mg	50	41070341/21.12/0703	Cancelled	S4	None
Xixia-bicalutamide 50 EACH TABLET CONTAINS BICALUTAMIDE 50,0 mg	50	41074541/21.12/0745	Registered	S4	None
Bicalox 50 MG EACH TABLET CONTAINS BICALUTAMIDE 50,0 mg	50 mg	41081841/21.12/0818	Registered	S4	None
Adco-bical 50 MG EACH TABLET CONTAINS BICALUTAMIDE 50,0 mg	50 mg	41090441/21.12/0904	Registered	S4	None
Adco-bical 150 MG EACH TABLET CONTAINS BICALUTAMIDE 150,0 mg	150 mg	41090541/21.12/0905	Registered	S4	None
Caloxa 50 MG EACH TABLET CONTAINS BICALUTAMIDE 5,0 mg	50 mg	42043042/21.12/0430	Registered	S4	None
Accord-bicalutamide EACH TABLET CONTAINS :BICALUTAMIDE 5,0 mg	Not listed	42043142/21.12/0431	Registered	S4	None
Anandroca 50 tablets EACH TABLET CONTAINS BICALUTAMIDE 50,0 mg	50Tablets	42080442/21.12/0804	Registered	S4	None
Spec-bicalutamide 50 EACH TABLET CONTAINS BICALUTAMIDE 50,0 mg	50	43040243/21.12/0402	Registered	S4	None
Spec-bicalutamide 150 EACH TABLET CONTAINS BICALUTAMIDE 150,0 mg	150	43062043/21.12/0620	Registered	S4	None
Bicalutamide 50 teva EACH TABLET CONTAINS BICALUTAMIDE 50,0 mg	50	43076443/21.12/0764	Registered	S4	None
Bicalutamide 150 teva EACH TABLET CONTAINS BICALUTAMIDE 150,0 mg	150	43076543/21.12/0765	Registered	S4	None
Tasdiam 50 EACH TABLET CONTAINS BICALUTAMIDE 50,0 mg	50	44102244/21.12/1022	Registered	S4	None
Tasdiam 150 EACH TABLET CONTAINS BICALUTAMIDE 150,0 mg	150	44102344/21.12/1023	Registered	S4	None
Bicalutamide 150 accord EACH TABLET CONTAINS BICALUTAMIDE 150,0 mg	150mgTablet	54088054/21.12/0880Approved 22 February 2022	Registered	S4	PI PIL
Bicalutamide 50 MG AURO EACH TABLET CONTAINS: BICALUTAMIDE 50,0 mg	50 mgFilm-coated tablet	59074859/21.12/0748Approved 21 July 2026	Registered	S4	PI PIL
Bicalutamide 150 MG AURO EACH TABLET CONTAINS: BICALUTAMIDE 150,0 mg	150 mgFilm-coated tablet	59074959/21.12/0749Approved 21 July 2026	Registered	S4	PI PIL
Bicadex EACH TABLET CONTAINS BICALUTAMIDE 50,0 mg	Not listed	A400304A40/21.12/0304	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, read from the product's PI-PIL leaflet.

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 Bicalutamide

S4: Bicalutamide
Consolidated Schedules 06 July 2026, line 5493

Pharmacological class: Hormone inhibitors. (class 21.12)

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

Casodex 50, Astrazeneca Pharmaceuticals (Pty) Ltd is scheduled S4 in its official SAHPRA documents, read with 90% confidence.

Professional information (PI)For healthcare professionalsCasodex 50, Astrazeneca Pharmaceuticals (Pty) Ltd Patient information leaflet (PIL)For patients and carersCasodex 50, Astrazeneca Pharmaceuticals (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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