Regulatory PathRegulatory requirements compared

Active substance

Cefixime

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
CEFIM 100 POWDER FOR ORAL SUSPENTION20 mg/mlSuspension · Oral use1 BottleSAR 36.30Generic · PrescriptionOMAN PHARMACEUTICAL PRODUCTSValid
CEFIM 200MG CAPSULES200 mgCapsule · Oral use8 BlisterSAR 44.70Generic · PrescriptionOMAN PHARMACEUTICAL PRODUCTSValid
CEFIM 400MG CAPSULES400 mgCapsule · Oral use6 BlisterSAR 45.95Generic · PrescriptionOMAN PHARMACEUTICAL PRODUCTSValid
CEFIX 100MG-5ML SUSPENSION20 mg/mlSuspension · Oral use1 BottleSAR 34.75Generic · PrescriptionPharma International Co.Valid
CEFIX 200MG CAPSULES200 mgCapsule, hard · Oral use8 BlisterSAR 36.30Generic · PrescriptionPharma International Co.Valid
CEFIX 400MG CAPSULES400 mgCapsule, hard · Oral use6 BlisterSAR 45.80Generic · PrescriptionPharma International Co.Valid
CEFRAX 400MG CAPSULES400 mgCapsule · Oral use6 BlisterSAR 49.55Generic · PrescriptionNational Pharmaceutical Industries Co. (SAOG)Valid
MAGNACEF 100MG\5ML SUSP20 mg/mlOral suspension · Oral use1 BottleSAR 36.60Generic · PrescriptionRam Pharmaceutical IndustriesValid
MAGNACEF 200MG CAP.200 mgCapsule · Oral use8 BlisterSAR 46.65Generic · PrescriptionRam Pharmaceutical IndustriesValid
MAGNACEF 400MG CAP400 mgCapsule · Oral use6 BlisterSAR 67.55Generic · PrescriptionRam Pharmaceutical IndustriesValid
MIDIXIME 100MG\5ML20 mg/mlPowder for oral suspension · Oral use1 BottleSAR 19.95Generic · PrescriptionMed City PharmaValid
MIDIXIME 200 mg Capsules200 mgCapsule · Oral use8 BlisterSAR 21.75Generic · PrescriptionMed City PharmaValid
MIDIXIME 400 mg Capsules400 mgCapsule · Oral use6 BlisterSAR 34.70Generic · PrescriptionMed City PharmaValid
MIXIF20 mg/mlPowder for oral suspension · Oral use1 BottleSAR 25.15Generic · PrescriptionDAR ALDAWAValid
MIXIF 400 mg Capsules400 mgCapsule · Oral use5 BlisterSAR 41.30Generic · PrescriptionDAR ALDAWAValid
Mixif400 mgCapsule, hard · Oral use10 BlisterSAR 75.50Generic · PrescriptionDAR ALDAWAValid
SUPRAX 100 SUSP20 mg/mlOral suspension · Oral use1 BottleSAR 44.95NCE · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
SUPRAX 200 CAPS200 mgCapsule · Oral use8 BlisterSAR 48.85NCE · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
SUPRAX 400 CAPS400 mgCapsule · Oral use6 BlisterSAR 72.50NCE · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
SUPRAX D 400MG TABLET400 mgDispersible tablet · Oral use6 BlisterSAR 72.50Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
Suprax40 mg/mlPowder for oral suspension · Oral use1 BottleSAR 74.90NCE · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
WINEX 100MG\5ML ORAL SUSP20 mg/mlSuspension · Oral use1 BottleSAR 40.35Generic · PrescriptionTabuk Pharmaceutical Manufacturing CompanyValid
WINEX 200MG CAP200 mgCapsule · Oral use8 BlisterSAR 49.65Generic · PrescriptionTabuk Pharmaceutical Manufacturing CompanyValid
WINEX 400MG CAP400 mgCapsule · Oral use6 BlisterSAR 67.95Generic · PrescriptionTabuk Pharmaceutical Manufacturing CompanyValid
APEX 400MG CAPSULE400 mgCapsule · Oral use6 BlisterSAR 49.55Generic · PrescriptionRETAJ Pharmaceutical IndustriesWithdrawn by regulatory authority · Not Marketed

8 more — full table

Indications — CHI Daman Drug Formulary

ACUTE BACTERIAL PROSTATITIS; ACUTE PYELONEPHRITIS; BACTERIAL TONSILLOPHARYNGITIS TREATMENT AND PREVENTION; LOWER URINARY TRACT INFECTIONS; MUCOPURULENT CONJUCTIVITIS - GONOCOCCAL INFECTION OF THE EYE; ORCHITIS AND EPIDIDYMITIS; OSTEOMYELITIS; Pyogenic Arthritis; TRAVEL RELATED INFECTIONS-TREATMENT

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

ProductStrengthForm · routeApplicantStatusFirst approved
SUPRAX200MG/5MLfor suspension · oralLUPIN PHARMSPrescription10 Apr 2007
SUPRAX400MGcapsule · oralLUPIN LTDPrescription1 Jun 2012
SUPRAX500MG/5MLfor suspension · oralLUPIN LTDPrescription20 Feb 2013
CEFIXIME100MG/5ML; 200MG/5MLfor suspension · oralAUROBINDO PHARMA LTDPrescription14 Apr 2015
CEFIXIME100MG/5ML; 200MG/5MLfor suspension · oralAJENAT PHARMSPrescription6 Feb 2017
CEFIXIME500MG/5MLfor suspension · oralAJENAT PHARMSPrescription6 Feb 2017
CEFIXIME400MGcapsule · oralALKEM LABS LTDPrescription9 Oct 2018
CEFIXIME100MG/5ML; 200MG/5MLfor suspension · oralALKEM LABS LTDPrescription19 Feb 2021
CEFIXIME400MGtablet · oralFDC LTDPrescription17 Dec 2024
CEFIXIME400MGcapsule · oralAUROBINDO PHARMA LTDPrescription23 Mar 2026
CEFIXIME100MG/5ML; 200MG/5MLfor suspension · oralFDC LTDPrescription14 May 2026
SUPRAX200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralLEDERLEDiscontinued28 Apr 1989
SUPRAX100MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**for suspension · oralLEDERLEDiscontinued28 Apr 1989
SUPRAX400MGtablet · oralLUPIN PHARMSDiscontinued12 Feb 2004
SUPRAX100MG/5MLfor suspension · oralLUPIN PHARMSDiscontinued23 Feb 2004
SUPRAX100MG; 150MG; 200MGtablet, chewable · oralLUPIN LTDDiscontinued25 Oct 2010
CEFIXIME100MG/5ML; 200MG/5MLfor suspension · oralCHARTWELL RXDiscontinued17 Nov 2017

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
AURO-CEFIXIME02432773400 MGTABLET · ORALAURO PHARMA INC
AURO-CEFIXIME02468689100 MG / 5 MLPOWDER FOR SUSPENSION · ORALAURO PHARMA INC
SUPRAX00868965100 MG / 5 MLPOWDER FOR SUSPENSION · ORALODAN LABORATORIESLTD
SUPRAX00868981400 MGTABLET · ORALODAN LABORATORIESLTD

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACCEFIXIME 100 MG/5 ML SUSP$2.44303per ML23 Sep 2026
US NADACCEFIXIME 200 MG/5 ML SUSP$3.42661per ML23 Sep 2026
US NADACCEFIXIME 400 MG CAPSULE$10.02817per EA23 Sep 2026
NHS Drug TariffCefixime 200mg tablets£13.237 tablet1 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)

  • 6.2.2. Watch group antibiotics · core
    Second choice: Infectious gastroenteritis or colitis without specification of infectious agent; Second choice: Gonococcal infection (co-prescribed with azithromycin)
    Oral > Liquid: 100 mg per 5 mL powder for oral liquid (EMLc) | Oral > Solid: 200 mg (as trihydrate); 400 mg (as trihydrate)

Safety signals and safety-related labeling changes

  • US FDA 22 May 2025 SUPRAX — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 29 Oct 2019 SUPRAX — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for cefixime →

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.