Regulatory PathRegulatory requirements compared

Active substance

Metronidazole

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
AMRIZOLE 250 Mg TABLET250 mgFilm-coated tablet · Oral use20 BlisterSAR 9.55Generic · PrescriptionALAMRIAH FOR PHARMACEUTICALS INDUSTRIESValid
AMRIZOLE 500MG VAGINAL SUPPOSITORIES500 mgSuppository · Vaginal use5 BlisterSAR 7.80Generic · PrescriptionALAMRIAH FOR PHARMACEUTICALS INDUSTRIESValid
AMRIZOLE INJ 500MG-100ML BOTTLE5 mg/mlSolution · Intravenous use1 BottleSAR 9.50Generic · PrescriptionALAMRIAH FOR PHARMACEUTICALS INDUSTRIESValid
AMRIZOLE SUSP 125MG-5ML25 mg/mlSuspension · Oral use1 BottleSAR 6.55Generic · PrescriptionALAMRIAH FOR PHARMACEUTICALS INDUSTRIESValid
ANAZOL500 mgFilm-coated tablet · Oral use130 BlisterSAR 88.55Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
ANAZOL250 mgFilm-coated tablet · Oral use130 BlisterSAR 41.95Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
ANAZOL 125MG-5ML SUSP.25 mg/mlSuspension · Oral use1 BottleSAR 6.90Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
ANAZOL 200MG-5ML SUSPENSION40 mg/mlSuspension · Oral use1 BottleSAR 10.05Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
ANAZOL 250 MG F.C. TAB250 mgFilm-coated tablet · Oral use20 BlisterSAR 6.45Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
ANAZOL 500 MG F.C. TAB500 mgFilm-coated tablet · Oral use20 BlisterSAR 14.85Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
FLAGYL 250MG TAB250 mgFilm-coated tablet · Oral use20 BlisterSAR 10.05NCE · Prescriptionsanofi-aventisValid
FLAGYL 500MG SCORED TABS500 mgFilm-coated tablet · Oral use14 BlisterSAR 19.15Generic · Prescriptionsanofi-aventisValid
FLAZOL 125MG-5ML ORAL SUSP25 mg/mlSuspension · Oral use1 BottleSAR 9.25Generic · PrescriptionTabuk Pharmaceutical Manufacturing CompanyValid
FLAZOL 500MG TAB500 mgFilm-coated tablet · Oral use20 BlisterSAR 19.90Generic · PrescriptionTabuk Pharmaceutical Manufacturing CompanyValid
METRONIDAZOLE 500MG-100ML INFUSION5 mg/mlSolution for infusion · Intravenous use1 BottleSAR 8.15Generic · PrescriptionPharmaceutical Solution Industries (PSI)Valid
METRONIDAZOLE 500MG/100ML INTRAVENOUS INFUSION5 mg/mlSolution for infusion · Intravenous use1 BottleSAR 10.00Generic · PrescriptionPharmaceutical Solution Industries (PSI)Valid
MOPIZALE 500MG/100ML SOLUTION FOR INFUSION5 mg/mlSolution for infusion · Intravenous use10 VialSAR 68.00Generic · PrescriptionMS Pharma Saudi (MSPS)Valid
Metronidazole intravenous infusion5 mg/mlSolution for infusion · Intravenous use1 BottleSAR 10.50Generic · PrescriptionB. BRAUNValid
Metrosol5 mg/mlSolution for infusion · Intravenous use1 BottleSAR 10.00Generic · PrescriptionAL RAZI PHARMA INDUSTRIESValid
NEGAZOLE250 mgFilm-coated tablet · Oral use100 BlisterSAR 26.00Generic · PrescriptionGULF PHARMACEUTICAL INDUSTIRES- JULPHARValid
NEGAZOLE 250MG TAB.250 mgTablet · Oral use20 BlisterSAR 5.20Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Valid
NEGAZOLE 500MG TAB.500 mgTablet · Oral use20 BlisterSAR 12.05Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Valid
Nuvessa1.3 %Gel · Vaginal use1 ApplicatorSAR 75.90NCE · PrescriptionExeltis USA IncValid
RIAZOLE500 mgFilm-coated tablet · Oral use20 BlisterSAR 19.90Generic · PrescriptionRIYADH PHARMAValid
ROZEX GEL 0.75% W-W0.75 %Gel · Topical1 TubeSAR 19.75Generic · PrescriptionGALDERMAValid

26 more — full table

Indications — CHI Daman Drug Formulary

ANTIBIOTIC SURGICAL PROPHYLAXIS; BACTERIAL GENITAL TRACT INFECTIONS; BACTERIAL SKIN INFECTIONS - GAS GANGRENE; BACTERIAL SKIN INFECTIONS - NECROTIZING FASCIITIS; BACTERIAL SKIN INFECTIONS - SURGICAL SITE INFECTIONS; BACTRIAL INFECTIONS OF THE GASTROINTESTINAL TRACT - CLOSTRIDIUM DIFFICILE INFECTIONS; BACTRIAL INFECTIONS OF THE GASTROINTESTINAL TRACT- H-PYLORI ERADICATION-EVIDENCE BASED FIRST LINE TREATMENT STRATEGY; BACTRIAL INFECTIONS OF THE GASTROINTESTINAL TRACT- H-PYLORI ERADICATION-SALVAGE THERAPIES; BALANTIDIASIS; BLASTOCYSTIS; CROHN'S DISEASE; DENTAL ABSCESS; DIENTAMOEBA; ENTAMOEBA HISTOLYTICA INFECTION; GIARDIA LAMBLIA INFECTION; INTRA-ABDOMINAL INFECTIONS; LICHEN PLANUS; LIVER CIRRHOSIS; NECROTIZING PERIODONTITIS AND NECROTIZING ULCERATIVE GINGIVITIS; OSTEOMYELITIS; PERICORONITIS; PERITONITIS; TRAVELLER'S DIARRHEA; TRICHOMONAS VAGINALIS; ULCERATIVE COLITIS

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

ProductStrengthForm · routeApplicantStatusFirst approved
FLAGYL I.V. RTU IN PLASTIC CONTAINER500MG/100MLinjectable · injectionBAXTER HLTHCAREPrescription24 Dec 1981
METRONIDAZOLE IN PLASTIC CONTAINER500MG/100MLinjectable · injectionHOSPIRAPrescription18 Nov 1983
METRONIDAZOLE250MGtablet · oralTEVA PHARMS USAPrescription6 Dec 1984
METRONIDAZOLE500MGtablet · oralPLIVAPrescription6 Dec 1984
METRONIDAZOLE250MGtablet · oralWATSON LABSPrescription20 Dec 1984
METRONIDAZOLE500MGtablet · oralWATSON LABS INCPrescription8 Feb 1985
METRONIDAZOLE250MG; 500MG; 125MGtablet · oralINNOGENIXPrescription16 Jul 1986
FLAGYL375MGcapsule · oralPFIZERPrescription3 May 1995
METROCREAM0.75%cream · topicalGALDERMA LABS LPPrescription20 Sep 1995
NORITATE1%cream · topicalBAUSCHPrescription26 Sep 1997
METROLOTION0.75%lotion · topicalGALDERMA LABS LPPrescription24 Nov 1998
METRONIDAZOLE375MGcapsule · oralCHARTWELL RXPrescription29 Jan 2004
METRONIDAZOLE0.75%cream · topicalFOUGERA PHARMSPrescription28 May 2004
VANDAZOLE0.75%gel · vaginalTEVA PHARMSPrescription20 May 2005
METROGEL1%gel · topicalGALDERMA LABS LPPrescription30 Jun 2005
METRONIDAZOLE0.75%lotion · topicalFOUGERA PHARMSPrescription24 May 2006
METRONIDAZOLE0.75%gel · topicalFOUGERA PHARMSPrescription6 Jun 2006
METRONIDAZOLE0.75%gel · topicalENCUBEPrescription13 Jul 2006
METRONIDAZOLE0.75%gel · topicalTAROPrescription18 Jul 2006
METRONIDAZOLE0.75%cream · topicalCOSETTE PHARMS NCPrescription19 Dec 2007
METRONIDAZOLE250MG; 500MGtablet · oralALEMBIC PHARMS LTDPrescription13 Mar 2009
METRONIDAZOLE375MGcapsule · oralALEMBICPrescription23 Jun 2009
METRONIDAZOLE0.75%gel · topicalCOSETTE PHARMS NCPrescription19 Jan 2011
METRONIDAZOLE250MG; 500MGtablet · oralUNICHEMPrescription22 Jan 2014
NUVESSA1.3%gel · vaginalALEMBIC THERAPPrescription24 Mar 2014

69 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
APO-METRONIDAZOLE02248562500 MGCAPSULE · ORALAPOTEX INC
APO-METRONIDAZOLE TABLETS00545066250 MGTABLET · ORALAPOTEX INC
AURO-METRONIDAZOLE02470284500 MGCAPSULE · ORALAURO PHARMA INC
M-METRONIDAZOLE02519755500 MGCAPSULE · ORALMANTRA PHARMA INC
METROGEL 0.75%020928320.75 %GEL · TOPICALGALDERMA CANADA INC.
METROGEL 1%022978091 %GEL · TOPICALGALDERMA CANADA INC.
METRONIDAZOLE02518767500 MGCAPSULE · ORALJAMP PHARMA CORPORATION
METRONIDAZOLE02534592500 MGCAPSULE · ORALSANIS HEALTH INC
METRONIDAZOLE INJECTION, USP008704205 MG / MLSOLUTION · INTRAVENOUSBAXTER CORPORATION
MINT-METRONIDAZOLE02535807250 MGTABLET · ORALMINT PHARMACEUTICALS INC
NIDAGEL021252260.75 % / W/WGEL · VAGINALBAUSCH HEALTH, CANADA INC.
NORITATE021560911 % / W/WCREAM · TOPICALBAUSCH HEALTH, CANADA INC.
PMS-METRONIDAZOLE00783137500 MGCAPSULE · ORALPHARMASCIENCE INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACLIKMEZ 500 MG/5 ML SUSPENSION$2.60822per ML23 Sep 2026
US NADACLIKMEZ 500 MG/5 ML SUSPENSION$2.60124per ML23 Sep 2026
US NADACMETRONIDAZOLE 0.75% CREAM$0.2571per GM23 Sep 2026
US NADACMETRONIDAZOLE 0.75% LOTION$1.81728per ML23 Sep 2026
US NADACMETRONIDAZOLE 250 MG TABLET$0.10165per EA23 Sep 2026
US NADACMETRONIDAZOLE 375 MG CAPSULE$7.30796per EA21 Jan 2026
US NADACMETRONIDAZOLE 500 MG TABLET$0.10426per EA23 Sep 2026
NHS Drug TariffMetronidazole 0.75% cream£12.3550 gram1 Oct 2026
NHS Drug TariffMetronidazole 0.75% gel£5.9815 gram1 Oct 2026
NHS Drug TariffMetronidazole 0.75% gel£22.6340 gram1 Oct 2026
NHS Drug TariffMetronidazole 0.75% vaginal gel£4.3140 gram1 Oct 2026
NHS Drug TariffMetronidazole 1g suppositories£23.0610 suppository1 Oct 2026
NHS Drug TariffMetronidazole 200mg tablets£0.9621 tablet1 Oct 2026
NHS Drug TariffMetronidazole 200mg/5ml oral suspension£44.92100 ml1 Oct 2026
NHS Drug TariffMetronidazole 400mg tablets£1.0221 tablet1 Oct 2026
NHS Drug TariffMetronidazole 500mg suppositories£15.1810 suppository1 Oct 2026
NHS Drug TariffMetronidazole 500mg tablets£8.8221 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)

  • 6.5.1. Antiamoebic and antigiardiasis medicines · core
    Amoebiasis
    Oral > Liquid: 200 mg per 5 mL (as benzoate) | Parenteral > General injections > unspecified: 500 mg in 100 mL vial | Oral > Solid > tablet: 200 mg; 250 mg; 400 mg; 500 mg
  • 6.2.1. Access group antibiotics · core
    First choice: Trichomoniasis; First choice: Intestinal infections due to Clostridioides difficile; First choice: Necrotising fasciitis; First choice: Other specified prophylactic measures (co-prescribed with cefazolin); First choice: Peritoneal abscess (mild-moderate) (co-prescribed with cefotaxime); First choice: Peritoneal abscess (severe) (co-prescribed with cefotaxime); First choice: Peritonitis (mild-moderate) (co-prescribed with cefotaxime); First choice: Peritonitis (severe) (co-prescribed with cefotaxime); First choice: Peritoneal abscess (mild-moderate) (co-prescribed with ceftriaxone); First choice: Peritoneal abscess (severe) (co-prescribed with ceftriaxone); First choice: Peritonitis (mild-moderate) (co-prescribed with ceftriaxone); First choice: Peritonitis (severe) (co-prescribed with ceftriaxone); Second choice: Peritoneal abscess (mild-moderate) (co-prescribed with ciprofloxacin); Second choice: Peritonitis (mild-moderate) (co-prescribed with ciprofloxacin)
    Oral > Liquid: 200 mg per 5 mL (as benzoate) | Local > Rectal > Suppository: 500 mg; 1 g | Parenteral > General injections > unspecified: 500 mg per 100 mL in vial | Oral > Solid > tablet: 200 mg; 250 mg; 400 mg; 500 mg | Local > Rectal > Suppository: 500 mg (EML); 1 g (EML)

Safety signals and safety-related labeling changes

All safety entries for metronidazole →

Combinations containing Metronidazole

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.