Fluconazole
Sold as Diflucan, Fluzol, Rucintix, Hexal-fluconazole, Fluconazole unicorn, Flucoric, Simayla fluconazole, *Flucoric otc, Aspen fluconazole, Vari-fluconazole, Fluconazole austell, Cipla fluconazole, Difluzole, Fluconazole GDC, Glenmark-fluconazole, Bio-fluconazole, Bio-fluconazole iv, Spec-fluconazole, Auro-fluconazole, Insep, SPEC fluconazole, Difuject, Aricon, Fluconazole fresenius, Fluconazole ascendis, Dezzo fluconazole, Fluconazole b braun, Flucosept, Apex-fluconazole, Ralmient, Mycorest, Aspen fluconazole iv, Exomax, Zydus fluconazole, Diflucan iv
2-(2,4-Difluorophenyl)-1,3-bis(1,2,4-triazol-1-yl)propan-2-ol
Drag to rotate. Structure from PubChem CID 3365.
Background
Registration
- Applicants
- 24
- Registrations
- 80
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Pfizer Laboratories (Pty) Ltd2 of 9 cancelled | Diflucan, Diflucan iv | 50 mg/ 5 ml, 50 mg, 50 ml, 100 mg, 100 mL, 150 mg, 200 mg, 200 mg/ 5 ml | 280150, 280151, 300150, 300151, 350187, V0339, V0340, Z0271, Z0272 | S4 | PIPIL |
| Sandoz South Africa (Pty) Ltd1 of 5 cancelled | Fluzol, Rucintix, Fluconazole unicorn, Hexal-fluconazole | 50, 150, 200 | 360261, 360262, 360263, 360265, 360266 | Not determined | None |
| Hexal Pharma (SA) (Pty) LtdCancelled | Hexal-fluconazole, Fluzol | 2mg/ 1ML, 2 mg/ 1ML, 50 | 360264, 370032, 370033 | Not determined | None |
| Ranbaxy (SA) (Pty) LtdCertificate held by Ranbaxy Pharmaceuticals (Pty) Ltd3 of 8 cancelled | Flucoric, Simayla fluconazole, *Flucoric otc | 50, 100, 150 mg, 200 | 370114, 370115, 370116, 370117, 370118, 370119, 370120, 370121 | Not determined | PIPIL |
| Pharmacare limited û woodmead | Aspen fluconazole, Aspen fluconazole iv | 50 mg, 100 mg, 150 mg, 200 mg | 370369, 370370, 370371, 370372, A390572 | Not determined | None |
| Lebasi Pharmaceuticals (Pty) Ltd | Vari-fluconazole | Not stated | 370583 | Not determined | None |
| Austell Pharmaceuticals (Pty) Ltd | Fluconazole austell | 50 mg, 150 mg, 200 mg | 380013, 380014, 380058 | Not determined | None |
| Cipla Medpro (Pty) Ltd | Cipla fluconazole, Difluzole | 50, 150, 200 | 380098, 380100, 380102 | Not determined | None |
| Gulf Drug Company (Pty) Ltd | Fluconazole GDC | 50, 150, 200 | 410107, 410124, 410240 | Not determined | None |
| Glenmark Pharmaceuticals South Africa (Pty) Ltd | Glenmark-fluconazole | 50, 150, 200 | 420369, 420370, 420371 | Not determined | None |
| Biotech Laboratories (Pty) Ltd | Bio-fluconazole, Bio-fluconazole iv | 50 mg, 150 mg, 200 mg | 420566, 420683, 420684, 420690 | Not determined | None |
| Specpharm (Pty) Ltd | Spec-fluconazole, SPEC fluconazole | 100 mg/50 ml, 150 | 420685, 440354 | Not determined | None |
| Aurogen South Africa (Pty) Ltd | Auro-fluconazole | 50 mg, 100 mg, 150 mg, 200 mg | 430560, 430561, 430562, 430563 | Not determined | None |
| Unimed Healthcare (Pty) Ltd | Insep | 50, 100, 150, 200 | 430566, 430567, 430568, 430569 | Not determined | None |
| Ranbaxy Pharmaceutical (Pty) LtdCancelled | Flucoric | infusion | 440481 | Not determined | None |
| Abex Pharmaceutica (Pty) Ltd | Difuject | 50 mg/25 ml, 200 mg/100 ml, 400 mg/200 ml | 440704, 440705, 440706 | Not determined | None |
| Teva Pharmaceuticals (Pty) LtdCancelled | Aricon | 50, 150, 200 | 450904, 450905, 450906 | Not determined | None |
| Fresenius Kabi South Africa (Pty) Ltd | Fluconazole fresenius | 2 mg/mL | 460312 | S4 | PIPIL |
| Dezzo Trading 392 (Pty) Ltd | Fluconazole ascendis, Dezzo fluconazole, Exomax | 2 mg/ml | 470874, 470875, A400115 | Not determined | None |
| B Braun Medical (Pty) LtdCertificate held by B. Braun Medical (Pty) Ltd. | Fluconazole b braun | 2 mg/mL | 480455 | S4 | PIPIL |
| Strides Pharma (SA) (Pty) Ltd | Flucosept | Not stated | 610456 | Not determined | None |
| Camox Pharmaceuticals (Pty) LtdCancelled | Apex-fluconazole | 50 mg, 150 mg, 200 mg | A380451, A380452, A380453 | Not determined | None |
| Trinity Pharma (Pty) Ltd | Ralmient | 50 mg, 100 mg, 150 mg, 200 mg | A380556, A380557, A380558, A380559 | Not determined | None |
| Zydus Healthcare (Pty) Ltd | Mycorest, Zydus fluconazole | 150 mg, 200 | A390534, A400437, A400438 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Diflucan capsules 100 MG EACH CAPSULE CONTAINS FLUCONAZOLE 100 mg | 100 mgCapsules | 28015028/20.2.2/0150 | Registered | Not determined | None |
| Diflucan capsules 200 MG EACH CAPSULE CONTAINS FLUCONAZOLE 200 mg | 200 mgCapsules | 28015128/20.2.2/0151 | Registered | Not determined | None |
| Diflucan 50 mg/ 5 ML EACH 5 ml SUSPENSION CONTAINS FLUCONAZOLE 50,0 mg | 50 mg/ 5 ml | 30015030/20.2.2/0150 | Registered | Not determined | None |
| Diflucan 200 mg/ 5 ML EACH 5 ml SUSPENSION CONTAINS FLUCONAZOLE 200,0 mg | 200 mg/ 5 ml | 30015130/20.2.2/0151 | Registered | Not determined | None |
| Diflucan tablets 200 MG EACH TABLET CONTAINS FLUCONAZOLE 200,0 mg | 200 mgTablets | 35018735/20.2.2/0187 | Cancelled | Not determined | None |
| Fluzol 50 EACH CAPSULE CONTAINS FLUCONAZOLE 50,0 mg | 50 | 36026136/20.2.2/0261 | Registered | Not determined | None |
| Rucintix EACH CAPSULE CONTAINS FLUCONAZOLE 150,0 mg | Not listed | 36026236/20.2.2/0262 | Registered | Not determined | None |
| Fluzol 200 EACH CAPSULE CONTAINS FLUCONAZOLE 200,0 mg | 200 | 36026336/20.2.2/0263 | Registered | Not determined | None |
| Hexal-fluconazole 50 EACH CAPSULE CONTAINS FLUCONAZOLE 50,0 mg | 50 | 36026436/20.2.2/264 | Cancelled | Not determined | None |
| Fluconazole unicorn 150 EACH CAPSULE CONTAINS FLUCONAZOLE 150,0 mg | 150 | 36026536/20.2.2/0265 | Registered | Not determined | None |
| Hexal-fluconazole 200 EACH CAPSULE CONTAINS FLUCONAZOLE 200,0 mg | 200 | 36026636/20.2.2/0266 | Cancelled | Not determined | None |
| Hexal-fluconazole 2mg/ 1ml EACH 1,0 ml SOLUTION CONTAINS FLUCONAZOLE 2,0 mg | 2mg/ 1ML | 37003237/20.2.2/0032 | Cancelled | Not determined | None |
| Fluzol 2 mg/ 1ml EACH 1,0 ml SOLUTION CONTAINS FLUCONAZOLE 2,0 mg | 2 mg/ 1ML | 37003337/20.2.2/0033 | Cancelled | Not determined | None |
| Flucoric 50 capsules EACH CAPSULE CONTAINS FLUCONAZOLE 50,0 mg | 50Capsules | 37011437/20.2.2/0114 | Registered | Not determined | None |
| Flucoric 100 capsules EACH CAPSULE CONTAINS FLUCONAZOLE 100,0 mg | 100Capsules | 37011537/20.2.2/0115 | Registered | Not determined | None |
| Flucoric 150 capsules EACH CAPSULE CONTAINS FLUCONAZOLE 150,0 mg | 150Capsules | 37011637/20.2.2/0116 | Registered | Not determined | None |
| Flucoric 200 capsules EACH CAPSULE CONTAINS FLUCONAZOLE 200,0 mg | 200Capsules | 37011737/20.2.2/0117 | Registered | Not determined | None |
| Simayla fluconazole 50 EACH CAPSULE CONTAINS FLUCONAZOLE 50,0 mg | 50 | 37011837/20.2.2/0118 | Cancelled | Not determined | None |
| Simayla fluconazole 100 EACH CAPSULE CONTAINS FLUCONAZOLE 100,0 mg | 100 | 37011937/20.2.2/0119 | Cancelled | Not determined | None |
| *Flucoric otc EACH CAPSULE CONTAINS :FLUCONAZOLE 150,0 mg | 150 mgCapsule | 37012037/20.2.2/0120Approved 12 November 2025 | Registered | Not determined | PIPIL |
| Simayla fluconazole 200 EACH CAPSULE CONTAINS FLUCONAZOLE 200,0 mg | 200 | 37012137/20.2.2/0121 | Cancelled | Not determined | None |
| Aspen fluconazole 50 MG EACH CAPSULE CONTAINS FLUCONAZOLE 50,0 mg | 50 mg | 37036937/20.2.2/0369 | Registered | Not determined | None |
| Aspen fluconazole 100 MG EACH CAPSULE CONTAINS FLUCONAZOLE 100,0 mg | 100 mg | 37037037/20.2.2/0370 | Registered | Not determined | None |
| Aspen fluconazole 150 MG EACH CAPSULE CONTAINS FLUCONAZOLE 150,0 mg | 150 mg | 37037137/20.2.2/0371 | Registered | Not determined | None |
| Aspen fluconazole 200 MG EACH CAPSULE CONTAINS FLUCONAZOLE 200,0 mg | 200 mg | 37037237/20.2.2/0372 | Registered | Not determined | None |
| Vari-fluconazole EACH CAPSULE CONTAINS FLUCONAZOLE 50,0 mg | Not listed | 37058337/20.2.2/0583 | Registered | Not determined | None |
| Fluconazole 50 MG austell EACH CAPSULE CONTAINS FLUCONAZOLE 50,0 mg | 50 mg | 38001338/20.2.2/0013 | Registered | Not determined | None |
| Fluconazole 200 MG austell EACH CAPSULE CONTAINS FLUCONAZOLE 200,0 mg | 200 mg | 38001438/20.2.2/0014 | Registered | Not determined | None |
| Fluconazole 150 MG austell EACH CAPSULE CONTAINS FLUCONAZOLE 150,0 mg | 150 mg | 38005838/20.2.2/0058 | Registered | Not determined | None |
| Cipla fluconazole 50 EACH CAPSULE CONTAINS FLUCONAZOLE 50,0 mg | 50 | 38009838/20.2.2/0098 | Registered | Not determined | None |
| Cipla fluconazole 200 EACH CAPSULE CONTAINS FLUCONAZOLE 200,0 mg | 200 | 38010038/20.2.2/0100 | Registered | Not determined | None |
| Difluzole 150 EACH CAPSULE CONTAINS FLUCONAZOLE 150,0 mg | 150 | 38010238/20.2.2/0102 | Registered | Not determined | None |
| Fluconazole 200 GDC EACH CAPSULE CONTAINS FLUCONAZOLE 200,0 mg | 200 | 41010741/20.2.2/0107 | Registered | Not determined | None |
| Fluconazole 150 GDC EACH CAPSULE CONTAINS FLUCONAZOLE 150,0 mg | 150 | 41012441/20.2.2/0124 | Registered | Not determined | None |
| Fluconazole 50 GDC EACH CAPSULE CONTAINS FLUCONAZOLE 50,0 mg | 50 | 41024041/20.2.2/0240 | Registered | Not determined | None |
| Glenmark-fluconazole 50 EACH TABLET CONTAINS FLUCONAZOLE 50,0 mg | 50 | 42036942/20.2.2/0369 | Registered | Not determined | None |
| Glenmark-fluconazole 150 EACH TABLET CONTAINS FLUCONAZOLE 150,0 mg | 150 | 42037042/20.2.2/0370 | Registered | Not determined | None |
| Glenmark-fluconazole 200 EACH TABLET CONTAINS FLUCONAZOLE 200,0 mg | 200 | 42037142/20.2.2/0371 | Registered | Not determined | None |
| Bio-fluconazole 50 MG EACH TABLET CONTAINS :FLUCONAZOLE 50,0 mg | 50 mg | 42056642/20.2.2/0566 | Registered | Not determined | None |
| Bio-fluconazole iv EACH 100,0 ml SOLUTION CONTAINS FLUCONAZOLE 200,0 mg | Not listed | 42068342/20.2.2/0683 | Registered | Not determined | None |
| Bio-fluconazole 150 MG EACH TABLET CONTAINS :FLUCONAZOLE 150,0 mg | 150 mg | 42068442/20.2.2/0684 | Registered | Not determined | None |
| Spec-fluconazole 150 EACH CAPSULE CONTAINS FLUCONAZOLE 150,0 mg | 150 | 42068542/20.2.2/0685 | Registered | Not determined | None |
| Bio-fluconazole 200 MG EACH TABLET CONTAINS :FLUCONAZOLE 200,0 mg | 200 mg | 42069042/20.2.2/0690 | Registered | Not determined | None |
| Auro-fluconazole 50 MG EACH CAPSULE CONTAINS FLUCONAZOLE 50,0 mg | 50 mg | 43056043/20.2.2/0560 | Registered | Not determined | None |
| Auro-fluconazole 100 MG EACH CAPSULE CONTAINS FLUCONAZOLE 100,0 mg | 100 mg | 43056143/20.2.2/0561 | Registered | Not determined | None |
| Auro-fluconazole 150 MG EACH CAPSULE CONTAINS FLUCONAZOLE 150,0 mg | 150 mg | 43056243/20.2.2/0562 | Registered | Not determined | None |
| Auro-fluconazole 200 MG EACH CAPSULE CONTAINS FLUCONAZOLE 200,0 mg | 200 mg | 43056343/20.2.2/0563 | Registered | Not determined | None |
| Insep 50 EACH CAPSULE CONTAINS FLUCONAZOLE 50,0 mg | 50 | 43056643/20.2.2/0566 | Registered | Not determined | None |
| Insep 100 EACH CAPSULE CONTAINS FLUCONAZOLE 100,0 mg | 100 | 43056743/20.2.2/0567 | Registered | Not determined | None |
| Insep 150 EACH CAPSULE CONTAINS FLUCONAZOLE 150,0 mg | 150 | 43056843/20.2.2/0568 | Registered | Not determined | None |
| Insep 200 EACH CAPSULE CONTAINS FLUCONAZOLE 200,0 mg | 200 | 43056943/20.2.2/0569 | Registered | Not determined | None |
| SPEC fluconazole 100 mg/50 ML EACH 50,0 ml BAG CONTAINS FLUCONAZOLE 100,0 mg | 100 mg/50 ml | 44035444/20.2.2/0354 | Registered | Not determined | None |
| Flucoric infusion EACH 1,0 ml SOLUTIN CONTAINS FLUCONAZOLE 2,0 mg | Infusion | 44048144/20.2.2/0481 | Cancelled | Not determined | None |
| Difuject 50 mg/25 ML EACH 1,0 ml SOLUTION CONTAINS :FLUCONAZOLE 2,0 mg | 50 mg/25 ml | 44070444/20.2.2/0704 | Registered | Not determined | None |
| Difuject 200 mg/100 ML EACH 1,0 ml SOLUTION CONTAINS :FLUCONAZOLE 2,0 mg | 200 mg/100 ml | 44070544/20.2.2/0705 | Registered | Not determined | None |
| Difuject 400 mg/200 ML EACH 1,0 ml SOLUTION CONTAINS: FLUCONAZOLE 2,0 mg | 400 mg/200 ml | 44070644/20.2.2/0706 | Registered | Not determined | None |
| Aricon 50 EACH TABLET CONTAINS: FLUCONAZOLE 50,0 mg | 50 | 45090445/20.2.2/0904 | Cancelled | Not determined | None |
| Aricon 150 EACH TABLET CONTAINS: FLUCONAZOLE 150,0 mg | 150 | 45090545/20.2.2/0905 | Cancelled | Not determined | None |
| Aricon 200 EACH TABLET CONTAINS: FLUCONAZOLE 200,0 mg | 200 | 45090645/20.2.2/0906 | Cancelled | Not determined | None |
| Fluconazole 2 mg/ml fresenius EACH 1,0 ml SOLUTION CONTAINS FLUCONAZOLE 2,0 mg | 2 mg/mLSolution for infusion | 46031246/20.2.2/0312Approved 13 February 2025 | Registered | S4 | PIPIL |
| Fluconazole ascendis 2 mg/ml EACH 1,0 ml SOLUTION CONTAINS FLUCONAZOLE 2,0 mg | 2 mg/ml | 47087447/20.2.2/0874 | Registered | Not determined | None |
| Dezzo fluconazole 2 mg/ml EACH 1,0 ml SOLUTION CONTAINS FLUCONAZOLE 2,0 mg | 2 mg/ml | 47087547/20.2.2/0875 | Registered | Not determined | None |
| Fluconazole 2 mg/ml b braun | 2 mg/mLSolution for infusion | 48045548/20.2.2/0455Approved 28 November 2022 | Registered | S4 | PIPIL |
| Flucosept EACH CAPSULE CONTAINS: FLUCONAZOLE 150,0 mg | Not listed | 61045661/20.2.2/0456 | Registered | Not determined | None |
| Apex-fluconazole 50 MG capsules EACH CAPSULE CONTAINS FLUCONAZOLE 50,0 mg | 50 mgCapsules | A380451A38/20.2.2/0451 | Cancelled | Not determined | None |
| Apex-fluconazole 150 MG capsules EACH CAPSULE CONTAINS FLUCONAZOLE 150,0 mg | 150 mgCapsules | A380452A38/20.2.2/0452 | Cancelled | Not determined | None |
| Apex-fluconazole 200 MG capsules EACH CAPSULE CONTAINS FLUCONAZOLE 200,0 mg | 200 mgCapsules | A380453A38/20.2.2/0453 | Cancelled | Not determined | None |
| Ralmient 50 MG EACH CAPSULE CONTAINS FLUCONAZOLE 50,0 mg | 50 mg | A380556A38/20.2.2/0556 | Registered | Not determined | None |
| Ralmient 100 MG EACH CAPSULE CONTAINS FLUCONAZOLE 100,0 mg | 100 mg | A380557A38/20.2.2/0557 | Registered | Not determined | None |
| Ralmient 150 MG EACH CAPSULE CONTAINS FLUCONAZOLE 150,0 mg | 150 mg | A380558A38/20.2.2/0558 | Registered | Not determined | None |
| Ralmient 200 MG EACH CAPSULE CONTAINS FLUCONAZOLE 200,0 mg | 200 mg | A380559A38/20.2.2/0559 | Registered | Not determined | None |
| Mycorest 150 EACH CAPSULE CONTAINS FLUCONAZOLE 150,0 mg | 150 | A390534A39/20.1.1/0534 | Registered | Not determined | None |
| Aspen fluconazole iv EACH 1,0 ml SOLUTION CONTAINS FLUCONAZOLE 2,0 mg | Not listed | A390572A39/20.2.2/0572 | Registered | Not determined | None |
| Exomax EACH 100,0 ml SOLUTION CONTAINS FLUCONAZOLE 200,0 mg | Not listed | A400115A40/20.2.2/0115 | Registered | Not determined | None |
| Zydus fluconazole 150 MG EACH CAPSULE CONTAINS FLUCONAZOLE 150,0 mg | 150 mg | A400437A40/20.2.2/0437 | Registered | Not determined | None |
| Mycorest 200 EACH CAPSULE CONTAINS FLUCONAZOLE 200,0 mg | 200 | A400438A40/20.2.2/0438 | Registered | Not determined | None |
| Diflucan capsules 50 MG EACH CAPSULE CONTAINS FLUCONAZOLE 50 mg | 50 mgCapsules | V0339V/20.2.2/339 | Cancelled | Not determined | None |
| Diflucan capsules 150 MG EACH CAPSULE CONTAINS FLUCONAZOLE 150 mg | 150 mgCapsules | V0340V/20.2.2/340 | Registered | Not determined | None |
| Diflucan iv infusion 50 ML EACH 1 ml SOLUTION CONTAINS FLUCONAZOLE 2 mg | 50 mlInfusion | Z0271Z/20.2.2/271 | Registered | Not determined | None |
| Diflucan iv infusion 100 ml* EACH 1 ml SOLUTION CONTAINS FLUCONAZOLE 2 mg | 100 mLInfusion | Z0272Z/20.2.2/272Approved 1 March 2022 | Registered | S4 | PIPIL |
Regulatory status
Where S4 sits on the scale
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 Fluconazole
S4: Fluconazole
- except as a single dose of 150 mg when indicated for the following fungal infections in adults
- Vaginal candidiasis, recurrent
- Candidial balanitis associated with vaginal candidiasis. (S2)
Consolidated Schedules 06 July 2026, lines 6351 to 6355
S2: Fluconazole
- as a single dose of 150 mg when indicated for the following fungal infections in adults:
- Vaginal candidiasis, recurrent
- Candidial balanitis associated with vaginal candidiasis.
Consolidated Schedules 06 July 2026, lines 1994 to 1998
Pharmacological class: Fungicides. (class 20.2.2)
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
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.