Regulatory PathRegulatory requirements compared

Active substance

Ceftriaxone

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
CEFAJECT 1 g IM1 gPowder for solution for injection/infusion · Intramuscular use1 VialSAR 40.95Generic · PrescriptionAbbott Laboratories GmbHValid
CEFAJECT 1 g IV1 gPowder for solution for injection/infusion · Intravenous use1 VialSAR 40.95Generic · PrescriptionAbbott Laboratories GmbHValid
CEFAJECT 500 mg IM500 mgPowder for solution for injection/infusion · Intramuscular use1 VialSAR 23.80Generic · PrescriptionAbbott Laboratories GmbHValid
CEFAJECT 500 mg IV500 mgPowder for solution for injection/infusion · Intravenous use1 VialSAR 23.80Generic · PrescriptionAbbott Laboratories GmbHValid
CEFAXON 1GM I.M+5 ML LIDOCAINE VIAL1 gSolution · Intramuscular use1 VialSAR 48.05Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
CEFAXON 1GM I.V VIAL1 gSolution for injection · Intravenous use1 VialSAR 48.05Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
CEFAXON 500 MG I.M+5 ML LIDOCAINE VIAL500 mgSolution · Intramuscular use1 VialSAR 29.30Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
CEFAXON 500 MG I.V VIAL500 mgSolution · Intravenous use1 VialSAR 14.85Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
Ceftriaxone Amarox1 gPowder and solvent for solution for injection · Intramuscular and intravenous use1 VialSAR 21.00Generic · PrescriptionSaudi AmaroxValid
Ceftriaxone Venus1 gPowder for solution for injection/infusion · Intramuscular and intravenous use1 VialSAR 19.15Generic · PrescriptionVENUS REMEDIES LIMITEDValid
ENOXIRT 0.25 g I.V. VIAL250 mgpowder for solution for injection · Intravenous use10 VialSAR 135.00Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Valid
ENOXIRT 0.25GM I.M. VIAL + SOLVENT250 mgpowder for solution for injection · Intramuscular use1 VialSAR 11.30Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Valid
ENOXIRT 0.25GM I.V. VIAL + SOLVENT250 mgpowder for solution for injection · Intravenous use1 VialSAR 11.30Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Valid
ENOXIRT 1 g I.V. VIAL1 gpowder for solution for injection · Intravenous use10 VialSAR 413.25Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Valid
ENOXIRT 1GM I.M. VIAL + SOLVENT1 gpowder for solution for injection · Intramuscular use1 VialSAR 45.30Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Valid
ENOXIRT 1GM I.V. VIAL + SOLVENT1 gpowder for solution for injection · Intravenous use1 VialSAR 45.30Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Valid
ENOXIRT 500 mg I.V. Vial500 mgpowder for solution for injection · Intravenous use10 VialSAR 239.00Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Valid
ENOXIRT 500MG I.M. VIAL + SOLVENT500 mgpowder for solution for injection · Intramuscular use1 VialSAR 22.65Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Valid
ENOXIRT 500MG I.V. VIAL + SOLVENT500 mgpowder for solution for injection · Intravenous use1 VialSAR 22.65Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Valid
MEGION 0.5GM I.V INJECTION500 mgSolution for injection · Intravenous use1 VialSAR 20.10Generic · PrescriptionSANDOZValid
MEGION 1GM I.V - I.M INJECTION1 gSolution for injection · Intramuscular use1 VialSAR 21.00Generic · PrescriptionSANDOZValid
MESPORIN 1000 I.M.1000 mgPowder and solvent for suspension for injection · Intramuscular use1 VialSAR 30.55Generic · PrescriptionAcino AGValid
MESPORIN 1000 I.V1 gPowder and solvent for suspension for injection · Intravenous use1 VialSAR 30.55Generic · PrescriptionAcino AGValid
MESPORIN 2000 I.V2 gPowder and solvent for suspension for injection · Intravenous use1 VialSAR 61.10Generic · PrescriptionAcino AGValid
MESPORIN 500 I.M.500 mgPowder and solvent for suspension for injection · Intramuscular use1 VialSAR 15.25Generic · PrescriptionAcino AGValid

50 more — full table

Indications — CHI Daman Drug Formulary

ACUTE BACTERIAL PROSTATITIS; ACUTE EXACERBATION OF BRONCHIECTASIS (NON-CYSTIC FIBROSIS); ACUTE PANCREATITIS; ACUTE PYELONEPHRITIS; ANTIBIOTIC SURGICAL PROPHYLAXIS; BACTERIAL MENINGITIS; BACTERIAL SKIN INFECTIONS - ERYSIPELAS AND CELLULITIS; BACTERIAL SKIN INFECTIONS - GAS GANGRENE; BACTERIAL SKIN INFECTIONS - NECROTIZING FASCIITIS; BACTERIAL SKIN INFECTIONS - SURGICAL SITE INFECTIONS; BACTRIAL INFECTIONS OF THE GASTROINTESTINAL TRACT - OTHER SALMONELLA INFECTIONS; BACTRIAL INFECTIONS OF THE GASTROINTESTINAL TRACT - SHIGELLA INFECTIONS; BACTRIAL INFECTIONS OF THE GASTROINTESTINAL TRACT - TYPHOID AND PARATYPHOID FEVERS; BACTRIAL INFECTIONS OF THE GASTROINTESTINAL TRACT - VIBRIO CHOLERAE; BRUCELLOSIS; COMMUNITY ACQUIRED PNEUMONEA; ENDOCARDITIS; HOSPITAL AND VENTILATER ACQUIRED PNEUMONIA; INTRA-ABDOMINAL INFECTIONS; LIVER CIRRHOSIS; MUCOPURULENT CONJUCTIVITIS - GONOCOCCAL INFECTION OF THE EYE; ORCHITIS AND EPIDIDYMITIS; OSTEOMYELITIS; OTITIS MEDIA; PELVIC INFLAMMATORY DISEASE; PERITONITIS; PREVENTION AND CHEMOPROPHYLAXIS OF BACTERIAL MENINGITIS- MENINGITIS, MENINGOCOCCAL INFECTIONS PREVENTION (CHEMOPROPHYLAXIS); Pyogenic Arthritis; RECURRENT URINARY TRACT INFECTIONS (UTI); Septic Shock; SICKLE CELL DISEASE - ACS MANAGEMENT; SINUSITIS; TRAVEL RELATED INFECTIONS-TREATMENT; URETHRITIS & NONGONOCOCCAL URETHRIIS

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

ProductStrengthForm · routeApplicantStatusFirst approved
CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINEREQ 1GM BASE/VIAL; EQ 2GM BASE/VIALinjectable · injectionB BRAUNPrescription20 Apr 2005
CEFTRIAXONEEQ 250MG BASE/VIAL; EQ 500MG BASE/VIAL; EQ 1GM BASE/VIAL; EQ 2GM BASE/VIALinjectable · intramuscular, intravenousSANDOZPrescription9 May 2005
CEFTRIAXONEEQ 10GM BASE/VIALinjectable · injectionSANDOZPrescription17 May 2005
CEFTRIAXONE IN PLASTIC CONTAINEREQ 20MG BASE/ML; EQ 40MG BASE/MLinjectable · injectionBAXTER HLTHCAREPrescription23 Aug 2005
CEFTRIAXONEEQ 1GM BASE/VIALinjectable · injectionAPOTEXPrescription12 May 2006
CEFTRIAXONEEQ 250MG BASE/VIAL; EQ 500MG BASE/VIAL; EQ 2GM BASE/VIALinjectable · intramuscular, intravenousWOCKHARDT BIO AGPrescription12 Apr 2007
CEFTRIAXONEEQ 250MG BASE/VIAL; EQ 500MG BASE/VIAL; EQ 1GM BASE/VIAL; EQ 2GM BASE/VIALinjectable · intramuscular, intravenousHIKMA FARMACEUTICAPrescription10 Jan 2008
CEFTRIAXONEEQ 250MG BASE/VIAL; EQ 500MG BASE/VIAL; EQ 1GM BASE/VIAL; EQ 2GM BASE/VIALinjectable · intramuscular, intravenousEPIC PHARMA LLCPrescription11 Jan 2008
CEFTRIAXONEEQ 10GM BASE/VIALinjectable · injectionACS DOBFARPrescription24 Jul 2008
CEFTRIAXONEEQ 500MG BASE/VIAL; EQ 1GM BASE/VIAL; EQ 2GM BASE/VIALinjectable · injectionACS DOBFARPrescription24 Jul 2008
CEFTRIAXONEEQ 100GM BASE/VIALinjectable · injectionSAMSON MEDCLPrescription25 Apr 2014
CEFTRIAXONEEQ 250MG BASE/VIAL; EQ 500MG BASE/VIAL; EQ 1GM BASE/VIAL; EQ 2GM BASE/VIALinjectable · intramuscular, intravenousQILU ANTIBIOTICSPrescription29 Jun 2016
CEFTRIAXONE SODIUMEQ 10GM BASE/VIALinjectable · injectionANDA REPOSITORYPrescription20 Jan 2017
CEFTRIAXONE SODIUMEQ 10GM BASE/VIALinjectable · injectionHIKMAPrescription4 Oct 2017
CEFTRIAXONEEQ 10GM BASE/VIALinjectable · injectionQILU ANTIBIOTICSPrescription17 Oct 2018
ROCEPHINEQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**injectable · intramuscular, intravenousHOFFMANN LA ROCHEDiscontinued21 Dec 1984
ROCEPHINEQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**injectable · injectionHOFFMANN LA ROCHEDiscontinued21 Dec 1984
ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINEREQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**injectable · injectionHOFFMANN LA ROCHEDiscontinued11 Feb 1987
ROCEPHINEQ 500MG BASE/VIAL; EQ 1GM BASE/VIAL; EQ 2GM BASE/VIALinjectable · injectionHOFFMANN LA ROCHEDiscontinued30 Apr 1987
ROCEPHINEQ 250MG BASE/VIAL; EQ 500MG BASE/VIAL; EQ 1GM BASE/VIALinjectable · injectionHOFFMANN LA ROCHEDiscontinued13 Aug 1993
CEFTRIAXONEEQ 250MG BASE/VIAL; EQ 500MG BASE/VIAL; EQ 1GM BASE/VIAL; EQ 2GM BASE/VIALinjectable · intramuscular, intravenousLUPINDiscontinued30 Sep 2003
CEFTRIAXONEEQ 1GM BASE/VIAL; EQ 2GM BASE/VIALinjectable · injectionSANDOZ INCDiscontinued3 May 2005
CEFTRIAXONEEQ 250MG BASE/VIAL; EQ 500MG BASE/VIAL; EQ 1GM BASE/VIAL; EQ 2GM BASE/VIALinjectable · intramuscular, intravenousHOSPIRA INCDiscontinued2 Aug 2005
CEFTRIAXONEEQ 1GM BASE/VIAL; EQ 2GM BASE/VIALinjectable · injectionHOSPIRA INCDiscontinued2 Aug 2005
CEFTRIAXONEEQ 10GM BASE/VIALinjectable · injectionHOSPIRA INCDiscontinued2 Aug 2005

18 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
CEFTRIAXONE FOR INJECTION022896951 G / VIALPOWDER FOR SOLUTION · INTRAVENOUS; INTRAMUSCULARFRESENIUS KABI CANADA LTD
CEFTRIAXONE FOR INJECTION022897092 G / VIALPOWDER FOR SOLUTION · INTRAMUSCULAR; INTRAVENOUSFRESENIUS KABI CANADA LTD
CEFTRIAXONE FOR INJECTION02409968100 G / BAGPOWDER FOR SOLUTION · INTRAVENOUSFRESENIUS KABI CANADA LTD
CEFTRIAXONE INJECTION, USP024997111000 MG / 50 MLSOLUTION · INTRAVENOUSBAXTER CORPORATION
CEFTRIAXONE INJECTION, USP024997382000 MG / 50 MLSOLUTION · INTRAVENOUSBAXTER CORPORATION
CEFTRIAXONE SODIUM FOR INJECTION BP02292262250 MG / VIALPOWDER FOR SOLUTION · INTRAVENOUS; INTRAMUSCULARSANDOZ CANADA INCORPORATED
CEFTRIAXONE SODIUM FOR INJECTION BP022922701 G / VIALPOWDER FOR SOLUTION · INTRAMUSCULAR; INTRAVENOUSSANDOZ CANADA INCORPORATED
CEFTRIAXONE SODIUM FOR INJECTION BP022922892 G / VIALPOWDER FOR SOLUTION · INTRAVENOUS; INTRAMUSCULARSANDOZ CANADA INCORPORATED
CEFTRIAXONE SODIUM FOR INJECTION BP0229229710 G / VIALPOWDER FOR SOLUTION · INTRAVENOUSSANDOZ CANADA INCORPORATED
CEFTRIAXONE SODIUM FOR INJECTION BP02325594250 MG / VIALPOWDER FOR SOLUTION · INTRAMUSCULAR; INTRAVENOUSSTERIMAX INC
CEFTRIAXONE SODIUM FOR INJECTION BP023256161 G / VIALPOWDER FOR SOLUTION · INTRAMUSCULAR; INTRAVENOUSSTERIMAX INC
CEFTRIAXONE SODIUM FOR INJECTION BP023256242 G / VIALPOWDER FOR SOLUTION · INTRAMUSCULAR; INTRAVENOUSSTERIMAX INC
CEFTRIAXONE SODIUM FOR INJECTION BP0232563210 G / VIALPOWDER FOR SOLUTION · INTRAVENOUSSTERIMAX INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACCEFTRIAXONE 1 GM VIAL$1.44341per EA23 Sep 2026
US NADACCEFTRIAXONE 1 GM VIAL$1.17324per EA23 Sep 2026
US NADACCEFTRIAXONE 2 GM VIAL$2.833per EA23 Sep 2026
US NADACCEFTRIAXONE 250 MG VIAL$0.8622per EA18 Feb 2026
US NADACCEFTRIAXONE 500 MG VIAL$1.84224per EA23 Sep 2026
US NADACCEFTRIAXONE 500 MG VIAL$1.31395per EA23 Sep 2026
NHS Drug TariffCeftriaxone 1g powder for solution for injection vials£9.581 vial1 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
    First choice: Other specified pneumonia (Hospital-acquired pneumonia); First choice: Acute pyelonephritis (severe); First choice: Paratyphoid fever; First choice: Typhoid fever; First choice: Endophthalmitis; First choice: Bacterial pneumonia (Community-acquired pneumonia - severe); First choice: Bacterial pneumonia (Community-acquired pneumonia - severe) [children]; First choice: Bacterial meningitis; First choice: Inflammatory or other diseases of prostate (severe) (co-prescribed with amikacin); First choice: Gonococcal infection (co-prescribed with azithromycin); First choice: Necrotising fasciitis (co-prescribed with metronidazole); First choice: Peritoneal abscess (mild-moderate) (co-prescribed with metronidazole); First choice: Peritoneal abscess (severe) (co-prescribed with metronidazole); First choice: Peritonitis (mild-moderate) (co-prescribed with metronidazole); First choice: Peritonitis (severe) (co-prescribed with metronidazole); Second choice: Acute pyelonephritis (mild to moderate); Second choice: Bacterial infection of joint; Second choice: Sepsis without septic shock; Second choice: Infectious gastroenteritis or colitis without specification of infectious agent; Second choice: Inflammatory or other diseases of prostate (mild to moderate); Second choice: Osteomyelitis or osteitis
    Parenteral > General injections > unspecified: 250 mg in vial powder for injection (as sodium salt); 500 mg in vial powder for injection (as sodium salt); 1 g in vial powder for injection (as sodium salt); 2 g in vial powder for injection (as sodium salt) (EML) | Parenteral > Locoregional injections > Intravitreal: 250 mg in vial powder for injection (as sodium salt); 500 mg in vial powder for injection (as sodium salt); 1 g in vial powder for injection (as sodium salt); 2 g in vial powder for injection (as sodium salt) (EML) | Parenteral > General injections > unspecified: 250 mg in vial powder for injection (as sodium salt) (EML); 500 mg in vial powder for injection (as sodium salt); 1 g in vial powder for injection (as sodium salt); 2 g in vial powder for injection (as sodium salt) | Parenteral > General injections > unspecified: 250 mg in vial powder for injection (as sodium salt); 500 mg in vial powder for injection (as sodium salt); 1 g in vial powder for injection (as sodium salt) (EML); 2 g in vial powder for injection (as sodium salt) | Parenteral > General injections > unspecified: 250 mg in vial powder for injection (as sodium salt); 500 mg in vial powder for injection (as sodium salt); 1 g in vial powder for injection (as sodium salt); 2 g in vial (EML) | Parenteral > General injections > unspecified: 250 mg in vial powder for injection (as sodium salt) (EMLc); 500 mg in vial powder for injection (as sodium salt) (EMLc); 1 g in vial powder for injection (as sodium salt) (EMLc)
  • 5.1.6.1. Medicines for bacterial central nervous system infections · core
    First choice: Bacterial meningitis
    Parenteral > General injections > unspecified: 250 mg in vial powder for injection (as sodium salt); 500 mg in vial powder for injection (as sodium salt); 1 g in vial powder for injection (as sodium salt); 2 g in vial powder for injection (as sodium salt) (EML)

Safety signals and safety-related labeling changes

All safety entries for ceftriaxone →

Combinations containing Ceftriaxone

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.