Regulatory PathRegulatory requirements compared

Active substance

Fluconazole

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
CANDEUR 150MG CAPSULES150 mgCapsule · Oral use1 BlisterSAR 17.80Generic · PrescriptionTabuk Pharmaceutical Manufacturing CompanyValid
CANDEUR 2 mg/ml Solution For Infusion2 mg/mlSolution · Intravenous use1 VialSAR 26.05Generic · PrescriptionTabuk Pharmaceutical Manufacturing CompanyValid
CANDEUR 2 mg/ml Solution For Infusion2 mg/mlSolution · Intravenous use1 VialSAR 52.15Generic · PrescriptionTabuk Pharmaceutical Manufacturing CompanyValid
CANDIVAST 150MG CAP150 mgCapsule · Oral use1 BlisterSAR 19.45Generic · PrescriptionTHE ARAB PHARMACEUTICAL MANUFACTURING PSC (SAHAB)Valid
CANDIVAST 50MG CAP50 mgCapsule · Oral use7 BlisterSAR 45.45Generic · PrescriptionTHE ARAB PHARMACEUTICAL MANUFACTURING PSC (SAHAB)Valid
DIFLUCAN 150 mg capsule150 mgCapsule · Oral use1 BlisterSAR 19.45NCE · PrescriptionPFIZER HOLDING FRANCEValid
DIFLUCAN 200 mg capsule200 mgCapsule · Oral use7 BlisterSAR 340.60NCE · PrescriptionPFIZER HOLDING FRANCEValid
DIFLUCAN 50 mg capsule50 mgCapsule · Oral use7 BlisterSAR 45.45NCE · PrescriptionPFIZER HOLDING FRANCEValid
DURACAN 150MG CAPSULE150 mgCapsule, soft · Oral use1 BlisterSAR 19.45Generic · PrescriptionJamjoom Pharmaceuticals Factory CompanyValid
FLOCAZOLE 150 MG CAPSULES150 mgCapsule · Oral use1 BlisterSAR 19.45Generic · PrescriptionSPIMACO ADDWAEIHValid
FLOCAZOLE 50 MG CAPSULES50 mgCapsule · Oral use7 BlisterSAR 45.45Generic · PrescriptionSPIMACO ADDWAEIHValid
FLUCAND 200MG-100ML INFUSION VIAL2 mg/mlSolution for infusion · Intravenous use1 VialSAR 56.55Generic · PrescriptionHikma Pharmaceuticals PLCValid
FLUCAZOL 150 mg Capsule150 mgCapsule, hard · Oral use1 BlisterSAR 15.05Generic · PrescriptionNational Pharmaceutical Industries Co. (SAOG)Valid
FLUCAZOL 50 mg Capsule50 mgCapsule, hard · Oral use7 BlisterSAR 42.70Generic · PrescriptionNational Pharmaceutical Industries Co. (SAOG)Valid
FLUCO-SOL 2MG/ML SOLUTION FOR I.V. INFUSION2 mg/mlSolution for injection · Intravenous use1 VialSAR 57.95Generic · PrescriptionPharmaceutical Solution Industries (PSI)Valid
FLUKAS 100 VIAL2 mg/mlSolution for injection · Intravenous use1 VialSAR 21.05Generic · PrescriptionLES LABORATOIRES MEDISValid
FLUKAS 200 VIAL2 mg/mlSolution for injection · Intravenous use1 VialSAR 29.40Generic · PrescriptionLES LABORATOIRES MEDISValid
FUNGIMID 150MG CAPSULE150 mgCapsule · Oral use1 BlisterSAR 16.70Generic · PrescriptionMiddle East Pharmaceutical and Chemical Industries and Medical Appliances Co.Valid
FUNGIMID 50MG CAPSULE50 mgCapsule · Oral use7 BlisterSAR 19.45Generic · PrescriptionMiddle East Pharmaceutical and Chemical Industries and Medical Appliances Co.Valid
FUNZOL 150MG CAPSULES150 mgCapsule · Oral use1 BlisterSAR 15.05Generic · PrescriptionThe Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM)Valid
Funzol150 mgCapsule · Oral use168 BlisterSAR 2528.40Generic · PrescriptionThe Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM)Valid
ORAMAX 150MG CAPSULES150 mgCapsule · Oral use1 BlisterSAR 15.05Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Valid
ODECON 150 mg Capsule150 mgCapsule · Oral use1 BottleSAR 15.05Generic · PrescriptionNEOPHARMASuspended
CANDEUR 200MG CAPSULES200 mgCapsule · Oral use7 BlisterSAR 253.35Generic · PrescriptionTabuk Pharmaceutical Manufacturing CompanyInvalid · Not Marketed
CANDEUR 50MG CAPSULES50 mgCapsule · Oral use7 BlisterSAR 42.70Generic · PrescriptionTabuk Pharmaceutical Manufacturing CompanyInvalid · Not Marketed

12 more — full table

Indications — CHI Daman Drug Formulary

ADULT ACUTE LYMPHOCYTIC LEUKEMIA (ALL)-ADVERSE REACTIONS MANAGEMENT; ADULT ACUTE MYELOID LEUKAEMIA (AML); ANTIMICROBIAL PROPHYLAXIS IN CANCER PATIENTS; CANDIDIASIS OF SKIN AND NAIL; CUTANEOUS LEISHMANIASIS; ECZEMA; ESOPHAGEAL CANDIDIASIS & OROPHARYNGEAL CANDIDIASIS; FUNGAL GIT - COCCIDIOIDOMYCOSIS; FUNGAL GIT - CRYPTOCOCCOSIS; FUNGAL INFECTIONS OF THE GENITAL TRACT - CANDIDIASIS OF VULVA AND VAGINA & CANDIDIASIS OF OTHER UROGENITAL SITES; HUMAN IMMUNODEFICIENCY VIRUS; Invasive Candidiasis and Candidemia; ONYCHOMYCOSIS ,TINEA UNGUIUM; PEDIATRIC ACUTE LYMPHOBLASTIC LEUKAEMIA (ALL)-ADVERSE REACTIONS MANAGEMENT; Pyogenic Arthritis; RENAL TRANSPLANT; TRAVEL RELATED INFECTIONS-TREATMENT

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
DIFLUCAN50MG; 100MG; 200MG; 150MGtablet · oralPFIZERPrescription29 Jan 1990
DIFLUCAN50MG/5ML; 200MG/5MLfor suspension · oralPFIZERPrescription23 Dec 1993
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%200MG/100ML (2MG/ML); 100MG/50ML (2MG/ML); 400MG/200ML (2MG/ML)injectable · injectionHIKMA PHARMSPrescription29 Jul 2004
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%200MG/100ML (2MG/ML); 400MG/200ML (2MG/ML)injectable · injectionFRESENIUS KABI USAPrescription29 Jul 2004
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML); 400MG/200ML (2MG/ML)injectable · injectionHOSPIRAPrescription29 Jul 2004
FLUCONAZOLE50MG; 100MG; 150MG; 200MGtablet · oralDR REDDYS LABS INCPrescription29 Jul 2004
FLUCONAZOLE50MG; 100MG; 150MG; 200MGtablet · oralCHARTWELLPrescription29 Jul 2004
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML); 400MG/200ML (2MG/ML)injectable · injectionBAXTER HLTHCAREPrescription29 Jul 2004
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%200MG/100ML (2MG/ML)injectable · injectionHIKMA FARMACEUTICAPrescription23 Aug 2005
FLUCONAZOLE50MG; 100MG; 200MG; 150MGtablet · oralUNIQUEPrescription28 Sep 2005
FLUCONAZOLE50MG; 100MG; 150MG; 200MGtablet · oralGLENMARK PHARMS LTDPrescription25 Jan 2006
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML); 400MG/200ML (2MG/ML)injectable · injectionHIKMA PHARMSPrescription30 Jul 2008
FLUCONAZOLE50MG; 100MG; 150MG; 200MGtablet · oralAUROBINDO PHARMAPrescription7 Oct 2008
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML); 400MG/200ML (2MG/ML)injectable · injectionINFORLIFEPrescription30 Jul 2009
FLUCONAZOLE50MG/5ML; 200MG/5MLfor suspension · oralAUROBINDO PHARMAPrescription18 Sep 2009
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML); 400MG/200ML (2MG/ML); 100MG/50ML (2MG/ML)injectable · injectionWOODWARDPrescription26 May 2010
FLUCONAZOLE50MG; 100MG; 150MG; 200MGtablet · oralANI PHARMSPrescription7 Mar 2011
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML); 400MG/200ML (2MG/ML)injectable · injectionHIKMA FARMACEUTICAPrescription30 Jan 2012
FLUCONAZOLE50MG; 100MG; 150MG; 200MGtablet · oralZYDUS PHARMSPrescription16 Feb 2017
FLUCONAZOLE200MG/5MLfor suspension · oralZHEJIANG POLY PHARMPrescription21 Sep 2023
FLUCONAZOLE50MG; 100MG; 150MG; 200MGtablet · oralFDC LTDPrescription8 Jan 2026
DIFLUCAN IN SODIUM CHLORIDE 0.9%200MG/100ML (2MG/ML); 400MG/200ML (2MG/ML)injectable · injectionPFIZERDiscontinued29 Jan 1990
DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML); 400MG/200ML (2MG/ML)injectable · injectionPFIZERDiscontinued29 Jan 1990
DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100ML (2MG/ML); 400MG/200ML (2MG/ML)injectable · injectionPFIZERDiscontinued29 Jan 1990
FLUCONAZOLE50MG; 100MG; 150MG; 200MGtablet · oralTEVADiscontinued29 Jul 2004

23 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
ACT FLUCONAZOLE0228126050 MGTABLET · ORALTEVA CANADA LIMITED
ACT FLUCONAZOLE02281279100 MGTABLET · ORALTEVA CANADA LIMITED
AG-FLUCONAZOLE02555891150 MGCAPSULE · ORALANGITA PHARMA INC.
APO-FLUCONAZOLE0223737050 MGTABLET · ORALAPOTEX INC
APO-FLUCONAZOLE02237371100 MGTABLET · ORALAPOTEX INC
APO-FLUCONAZOLE-15002241895150 MGCAPSULE · ORALAPOTEX INC
BIO-FLUCONAZOLE02462168150 MGCAPSULE · ORALBIOMED PHARMA
CANESORAL02311690150 MGCAPSULE · ORALBAYER INC
DIFLUCAN008918352 MG / MLSOLUTION · INTRAVENOUSPFIZER CANADA ULC
DIFLUCAN0202415250 MG / 5 MLPOWDER FOR SOLUTION · ORALPFIZER CANADA ULC
DIFLUCAN ONE02141442150 MGCAPSULE · ORALPFIZER CANADA ULC
FLUCONAZOLE0251739650 MGTABLET · ORALSANIS HEALTH INC
FLUCONAZOLE02517418100 MGTABLET · ORALSANIS HEALTH INC
FLUCONAZOLE0253488650 MGTABLET · ORALSIVEM PHARMACEUTICALS ULC
FLUCONAZOLE02534894100 MGTABLET · ORALSIVEM PHARMACEUTICALS ULC
FLUCONAZOLE 15002352133150 MGCAPSULE · ORALAPOTEX INC
FLUCONAZOLE IN SODIUM CHLORIDE INJECTION USP022614722 MG / MLSOLUTION · INTRAVENOUSBAXTER CORPORATION
FLUCONAZOLE INJECTION SDZ023884482 MG / MLSOLUTION · INTRAVENOUSSANDOZ CANADA INCORPORATED
FLUCONAZOLE-15002521229150 MGCAPSULE · ORALSANIS HEALTH INC
JAMP FLUCONAZOLE 150 MG02547864150 MGCAPSULE · ORALJAMP PHARMA CORPORATION
M-FLUCONAZOLE-15002553406150 MGCAPSULE · ORALMANTRA PHARMA INC
MAR-FLUCONAZOLE-15002428792150 MGCAPSULE · ORALMARCAN PHARMACEUTICALS INC
MYLAN-FLUCONAZOLE0224529250 MGTABLET · ORALMYLAN PHARMACEUTICALS ULC
MYLAN-FLUCONAZOLE02245293100 MGTABLET · ORALMYLAN PHARMACEUTICALS ULC
NRA-FLUCONAZOLE-15002433702150 MGCAPSULE · ORALNORA PHARMA INC

4 more — full table

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACFLUCONAZOLE 10 MG/ML SUSP$0.27773per ML23 Sep 2026
US NADACFLUCONAZOLE 100 MG TABLET$0.22275per EA23 Sep 2026
US NADACFLUCONAZOLE 150 MG TABLET$0.46976per EA23 Sep 2026
US NADACFLUCONAZOLE 200 MG TABLET$0.37982per EA23 Sep 2026
US NADACFLUCONAZOLE 40 MG/ML SUSP$0.54679per ML23 Sep 2026
US NADACFLUCONAZOLE 50 MG TABLET$0.20764per EA23 Sep 2026
NHS Drug TariffFluconazole 150mg capsule and Clotrimazole 2% cream£11.071 pack1 Oct 2026
NHS Drug TariffFluconazole 150mg capsules£0.781 capsule1 Oct 2026
NHS Drug TariffFluconazole 200mg capsules£3.587 capsule1 Oct 2026
NHS Drug TariffFluconazole 200mg/5ml oral suspension£66.4235 ml1 Oct 2026
NHS Drug TariffFluconazole 50mg capsules£0.787 capsule1 Oct 2026
NHS Drug TariffFluconazole 50mg/5ml oral suspension£30.7435 ml1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

WHO WHO Model List of Essential Medicines (2025)

  • 6.3. Antifungal medicines · core
    Cryptococcosis; Candidosis
    Parenteral > General injections > IV: 2 mg per mL in vial | Oral > Liquid: 50 mg per 5 mL; 50 mg per 5 mL powder for oral liquid (EMLc) | Oral > Solid > capsule: 50 mg

Safety signals and safety-related labeling changes

All safety entries for fluconazole →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.