Regulatory PathRegulatory requirements compared

Active substance

Cefuroxime

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
CEFOFIX 750 MG VIALS750 mgSolution for infusion · Parenteral use1 VialSAR 11.00Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
CEFOVEX 500MG TABLET500 mgTablet · Oral use10 BlisterSAR 49.30Generic · PrescriptionOMAN PHARMACEUTICAL PRODUCTSValid
CEFUREX 125MG-5ML POWDER FOR SUSPENSION25 mg/mlPowder for suspension · Oral use1 BottleSAR 18.50Generic · PrescriptionMiddle East Pharmaceutical and Chemical Industries and Medical Appliances Co.Valid
CEFUREX 250MG F-C TABLETS250 mgFilm-coated tablet · Oral use10 BlisterSAR 20.80Generic · PrescriptionMiddle East Pharmaceutical and Chemical Industries and Medical Appliances Co.Valid
CEFUREX 250MG-5ML POWDER FOR SUSPENSION50 mg/mlPowder for suspension · Oral use1 BottleSAR 27.45Generic · PrescriptionMiddle East Pharmaceutical and Chemical Industries and Medical Appliances Co.Valid
CEFUREX 500MG F-C TABLETS500 mgFilm-coated tablet · Oral use10 BlisterSAR 34.05Generic · PrescriptionMiddle East Pharmaceutical and Chemical Industries and Medical Appliances Co.Valid
CEFUTIL 250MG F.C TABLET250 mgFilm-coated tablet · Oral use10 BlisterSAR 23.50Generic · PrescriptionPharma International Co.Valid
CEFUTIL 500 MG TABLETS500 mgFilm-coated tablet · Oral use10 BlisterSAR 36.05Generic · PrescriptionPharma International Co.Valid
CEFUZIME 125MG-5ML POWDER FOR ORAL SUSP25 mg/mlPowder for oral suspension · Oral use1 BottleSAR 23.15Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Valid
CEFUZIME 500 MG TAB500 mgFilm-coated tablet · Oral use10 BlisterSAR 63.95Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Valid
CEFUZIME 750 MG INJECTION,I.M - I.V VIAL750 mgPowder for injection · Parenteral use1 VialSAR 7.50Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Valid
CERUXIM 1.5 g powder for solution for injection or infusion1.5 gpowder for solution for injection · Parenteral use10 VialSAR 134.20Generic · PrescriptionMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRYValid
CERUXIM 250 mg Film Coted Tablet250 mgFilm-coated tablet · Oral use20 StripSAR 33.70Generic · PrescriptionMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRYValid
CERUXIM 500 mg Film Coted Tablet500 mgFilm-coated tablet · Oral use20 StripSAR 56.55Generic · PrescriptionMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRYValid
CERUXIM 750 mg powder for solution for injection or infusion750 mgpowder for solution for injection · Parenteral use10 VialSAR 67.10Generic · PrescriptionMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRYValid
Cefuroxime-Kotra750 mgPowder for injection · Intramuscular and intravenous use10 VialSAR 67.00Generic · PrescriptionKotra pharma M Sdn BhdValid
Cefuroxime-Venus750 mgPowder for solution for injection/infusion · Intramuscular and intravenous use1 VialSAR 6.70Generic · PrescriptionVENUS REMEDIES LIMITEDValid
Cefuzime500 mgFilm-coated tablet · Oral use15 BlisterSAR 85.85Generic · PrescriptionGULF PHARMACEUTICAL INDUSTIRES- JULPHARValid
DAROXIME500 mgFilm-coated tablet · Oral use10 BlisterSAR 32.95Generic · PrescriptionDAR ALDAWAValid
DAROXIME 250 mg film-coated tablet250 mgFilm-coated tablet · Oral use10 BlisterSAR 25.85Generic · PrescriptionDAR ALDAWAValid
Daroxime500 mgFilm-coated tablet · Oral use14 BottleSAR 46.05Generic · PrescriptionDAR Al DAWAValid
EMDITIL 500MG Film-coated TABLET500 mgFilm-coated tablet · Oral use10 BottleSAR 34.50Generic · PrescriptionMed City PharmaValid
MAXIL 1500 VIAL1.5 gPowder for injection · Parenteral use1 VialSAR 14.90Generic · PrescriptionHikma Pharmaceuticals PLCValid
MAXIL 750 VIAL750 mgPowder for injection · Parenteral use1 VialSAR 7.50Generic · PrescriptionHikma Pharmaceuticals PLCValid
U-CEF 500MG F.C. TABLETS500 mgFilm-coated tablet · Oral use10 BottleSAR 52.05Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid

26 more — full table

Indications — CHI Daman Drug Formulary

ACUTE PYELONEPHRITIS; ANTIBIOTIC SURGICAL PROPHYLAXIS; BACTERIAL SKIN INFECTIONS - ERYSIPELAS AND CELLULITIS; BACTERIAL SKIN INFECTIONS - IMPETIGO AND ECTHYMA; BACTERIAL TONSILLOPHARYNGITIS TREATMENT AND PREVENTION; COMMUNITY ACQUIRED PNEUMONEA; HIP AND KNEE REPLACEMENT SURGERY; HOSPITAL AND VENTILATER ACQUIRED PNEUMONIA; INTRA-ABDOMINAL INFECTIONS; Pyogenic Arthritis; SINUSITIS

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

ProductStrengthForm · routeApplicantStatusFirst approved
CEFUROXIME SODIUMEQ 750MG BASE/VIALinjectable · intramuscular, intravenousACS DOBFAR SPAPrescription30 May 1997
CEFUROXIME SODIUMEQ 1.5GM BASE/VIALinjectable · injectionACS DOBFAR SPAPrescription30 May 1997
CEFUROXIME SODIUMEQ 750MG BASE/VIALinjectable · intramuscular, intravenousHIKMAPrescription9 Jan 2004
CEFUROXIME SODIUMEQ 1.5GM BASE/VIALinjectable · injectionHIKMAPrescription9 Jan 2004
CEFUROXIME1.5G/20ML; 1.5G/100MLinjectable · injectionHIKMAPrescription9 Jan 2004
CEFUROXIME AXETILEQ 125MG BASE; EQ 250MG BASE; EQ 500MG BASEtablet · oralCHARTWELL RXPrescription29 Jul 2005
CEFUROXIME AXETILEQ 125MG BASE; EQ 250MG BASE; EQ 500MG BASEtablet · oralAUROBINDO PHARMAPrescription29 Mar 2006
CEFUROXIME AXETILEQ 125MG BASE; EQ 250MG BASE; EQ 500MG BASEtablet · oralANDA REPOSITORYPrescription15 Feb 2008
CEFUROXIME AXETILEQ 250MG BASE; EQ 500MG BASEtablet · oralALKEM LABS LTDPrescription7 Jun 2010
ZINACEFEQ 750MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**injectable · intramuscular, intravenousPAI HOLDINGS PHARMDiscontinued19 Oct 1983
ZINACEFEQ 1.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 7.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**injectable · injectionPAI HOLDINGS PHARMDiscontinued19 Oct 1983
KEFUROX IN PLASTIC CONTAINEREQ 750MG BASE/VIALinjectable · intravenousLILLYDiscontinued10 Jan 1986
KEFUROX IN PLASTIC CONTAINEREQ 1.5GM BASE/VIALinjectable · injectionLILLYDiscontinued10 Jan 1986
KEFUROXEQ 750MG BASE/VIALinjectable · intramuscular, intravenousACS DOBFARDiscontinued10 Jan 1986
KEFUROXEQ 1.5GM BASE/VIAL; EQ 7.5GM BASE/VIALinjectable · injectionACS DOBFARDiscontinued10 Jan 1986
KEFUROXEQ 750MG BASE/VIALinjectable · intravenousLILLYDiscontinued10 Jan 1986
KEFUROXEQ 1.5GM BASE/VIALinjectable · injectionLILLYDiscontinued10 Jan 1986
CEFTINEQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralGLAXOSMITHKLINEDiscontinued28 Dec 1987
ZINACEF IN PLASTIC CONTAINEREQ 15MG BASE/ML; EQ 30MG BASE/MLinjectable · injectionPAI HOLDINGS PHARMDiscontinued28 Apr 1989
CEFUROXIME SODIUMEQ 750MG BASE/VIALinjectable · intramuscular, intravenousWATSON LABS INCDiscontinued26 Feb 1993
CEFUROXIME SODIUMEQ 1.5GM BASE/VIALinjectable · injectionWATSON LABS INCDiscontinued26 Feb 1993
CEFUROXIME SODIUMEQ 7.5GM BASE/VIALinjectable · injectionWATSON LABS INCDiscontinued26 Feb 1993
CEFTINEQ 125MG BASE/5ML; EQ 250MG BASE/5MLfor suspension · oralGLAXOSMITHKLINEDiscontinued30 Jun 1994
CEFUROXIME SODIUMEQ 7.5GM BASE/VIALinjectable · injectionACS DOBFAR SPADiscontinued30 May 1997
CEFUROXIME SODIUMEQ 7.5GM BASE/VIALinjectable · injectionTEVA PHARMSDiscontinued16 Apr 1998

18 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
APO-CEFUROXIME02244393250 MGTABLET · ORALAPOTEX INC
APO-CEFUROXIME02244394500 MGTABLET · ORALAPOTEX INC
AURO-CEFUROXIME02344823250 MGTABLET · ORALAURO PHARMA INC
AURO-CEFUROXIME02344831500 MGTABLET · ORALAURO PHARMA INC
CEFTIN02212307125 MG / 5 MLGRANULES FOR SUSPENSION · ORALSANDOZ CANADA INCORPORATED
CEFUROXIME FOR INJECTION, USP02241638750 MG / VIALPOWDER FOR SOLUTION · INTRAVENOUSFRESENIUS KABI CANADA LTD
CEFUROXIME FOR INJECTION, USP022416391.5 G / VIALPOWDER FOR SOLUTION · INTRAVENOUSFRESENIUS KABI CANADA LTD
JAMP CEFUROXIME02547198250 MGTABLET · ORALJAMP PHARMA CORPORATION
JAMP CEFUROXIME02547201500 MGTABLET · ORALJAMP PHARMA CORPORATION

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACCEFUROXIME AXETIL 250 MG TAB$0.2798per EA23 Sep 2026
US NADACCEFUROXIME AXETIL 500 MG TAB$0.36555per EA23 Sep 2026
NHS Drug TariffCefuroxime 250mg tablets£9.1114 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: Other specified prophylactic measures
    Parenteral > General injections > IV: 250 mg in vial (as sodium salt) powder for injection; 750 mg in vial (as sodium salt) powder for injection; 1.5 g in vial (as sodium salt) powder for injection

Safety signals and safety-related labeling changes

All safety entries for cefuroxime →

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.