Regulatory PathRegulatory requirements compared

Active substance

Amoxicillin

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
AMOXIL 250MG CAP.250 mgCapsule · Oral use20 BlisterSAR 22.45Generic · PrescriptionSPIMACO ADDWAEIHValid
AMOXIL 500MG CAP.500 mgCapsule · Oral use20 BlisterSAR 44.90Generic · PrescriptionSPIMACO ADDWAEIHValid
AMOXIL POWDER FOR ORAL SUSPENSION 125MG-5ML25 mg/mlPowder for oral suspension · Oral use1 BottleSAR 16.80Generic · PrescriptionSPIMACO ADDWAEIHValid
AMOXIL POWDER FOR ORAL SUSPENSION FORTE 250MG-5ML50 mg/mlPowder for oral suspension · Oral use1 BottleSAR 27.85Generic · PrescriptionSPIMACO ADDWAEIHValid
E-MOX 125MG DRY MIX.125 mg/mlPowder for suspension · Oral use1 BottleSAR 6.15Generic · PrescriptionEIPICOValid
E-MOX 250MG DRY MIX.50 mg/mlPowder for suspension · Oral use1 BottleSAR 10.25Generic · PrescriptionEIPICOValid
E-MOX 500MG CAPS500 mgCapsule · Oral use16 BlisterSAR 10.25Generic · PrescriptionEIPICOValid
GLOMOX 500MG CAP500 mgCapsule · Oral use20 BlisterSAR 13.20Generic · PrescriptionGLOBAL PHARMAValid
HYMOX 125MG-5ML POWDER FOR ORAL SUSPENSION25 mg/mlPowder for oral suspension · Oral use1 BottleSAR 12.55Generic · PrescriptionSPIMACO ADDWAEIHValid
HYMOX 250MG CAPS250 mgCapsule · Oral use20 BlisterSAR 20.20Generic · PrescriptionSPIMACO ADDWAEIHValid
HYMOX 250MG-5ML POWDER FOR ORAL SUSPENSION50 mg/mlPowder for oral suspension · Oral use1 BottleSAR 25.05Generic · PrescriptionSPIMACO ADDWAEIHValid
HYMOX 500MG CAPS500 mgCapsule · Oral use20 BlisterSAR 40.40Generic · PrescriptionSPIMACO ADDWAEIHValid
HYMOX 875 mg film-coated tablet875 mgFilm-coated tablet · Oral use14 BlisterSAR 49.50Generic · PrescriptionSPIMACO ADDWAEIHValid
Juvamox50 mgPowder for oral suspension · Oral use1 BottleSAR 16.70Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Valid
Juvamox 500MG CAPSULES500 mgCapsule · Oral use20 BlisterSAR 22.55Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Valid
MOXIDAD CAPSULES 250 MG250 mgCapsule, hard · Oral use500 BlisterSAR 168.20Generic · PrescriptionDAR ALDAWAValid
MOXIDAD CAPSULES 250MG250 mgCapsule · Oral use20 BlisterSAR 7.30Generic · PrescriptionDAR ALDAWAValid
MOXIDAD FORTE500 mgCapsule · Oral use20 BlisterSAR 12.90Generic · PrescriptionDAR ALDAWAValid
Moxidad forte500 mgCapsule, hard · Oral use500 BlisterSAR 256.40Generic · PrescriptionDAR ALDAWAValid
OMACILLIN 100MG-ML ORAL DROPS100 mg/mlOral drops · Oral use1 BottleSAR 9.80Generic · PrescriptionNational Pharmaceutical Industries Co. (SAOG)Valid
REMOX 125MG-5ML SUSPENSION25 mg/mlPowder for oral suspension · Oral use1 BottleSAR 13.55Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
REMOX 250 MG CAPSULES250 mgCapsule · Oral use20 BlisterSAR 21.80Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
REMOX 250MG -5ML SUSPENSION50 mg/mlPowder for oral suspension · Oral use1 BottleSAR 27.05Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
REMOX 500 MG CAPSULES500 mgCapsule · Oral use20 BlisterSAR 43.60Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
Remox250 mgCapsule, hard · Oral use60 BlisterSAR 54.60Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid

45 more — full table

Indications — CHI Daman Drug Formulary

ACUTE COUGH; ACUTE EXACERBATION OF BRONCHIECTASIS (NON-CYSTIC FIBROSIS); ACUTE EXACERBATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD); ACUTE PYELONEPHRITIS; BACTERIAL SKIN INFECTIONS - ERYSIPELAS AND CELLULITIS; BACTERIAL TONSILLOPHARYNGITIS TREATMENT AND PREVENTION; BACTRIAL INFECTIONS OF THE GASTROINTESTINAL TRACT - OTHER SALMONELLA 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; COMMUNITY ACQUIRED PNEUMONEA; DENTAL ABSCESS; LOWER URINARY TRACT INFECTIONS; MARGINAL ZONE LYMPHOMA; OSTEOMYELITIS; OTITIS MEDIA; PERICORONITIS; PHARYNGITIS; Pyogenic Arthritis; RECURRENT URINARY TRACT INFECTIONS (UTI); SINUSITIS; TRAVEL RELATED INFECTIONS-TREATMENT

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

ProductStrengthForm · routeApplicantStatusFirst approved
AMOXICILLIN250MG; 500MGcapsule · oralCHARTWELL RXPrescription9 Feb 1976
AMOXICILLIN250MG; 500MGcapsule · oralCHARTWELLPrescription3 Aug 1978
AMOXIL250MG; 500MGcapsule · oralUS ANTIBIOTICSPrescription2 Aug 1979
AMOXIL125MG/5ML; 250MG/5ML; 50MG/MLfor suspension · oralUS ANTIBIOTICSPrescription27 Nov 1979
LAROTID125MG/5ML; 250MG/5MLfor suspension · oralUS ANTIBIOTICSPrescription27 Nov 1979
AMOXICILLIN250MG/5MLfor suspension · oralCHARTWELL RXPrescription1 Dec 1982
AMOXICILLIN PEDIATRIC50MG/MLfor suspension · oralCHARTWELL RXPrescription1 Dec 1982
AMOXICILLIN250MG; 125MGtablet, chewable · oralCHARTWELL RXPrescription22 Dec 1992
AMOXICILLIN250MG; 500MGcapsule · oralSANDOZPrescription30 Sep 1994
AMOXIL400MG/5MLfor suspension · oralUS ANTIBIOTICSPrescription15 Apr 1999
AMOXICILLIN500MG; 875MGtablet · oralCHARTWELL RXPrescription18 Sep 2000
AMOXICILLIN200MG/5ML; 400MG/5MLfor suspension · oralCHARTWELL RXPrescription4 Dec 2002
AMOXICILLIN500MG; 875MGtablet · oralSANDOZPrescription13 Jul 2005
AMOXICILLIN500MG; 875MGtablet · oralAUROBINDOPrescription9 Nov 2005
AMOXICILLIN250MG; 500MGcapsule · oralAUROBINDOPrescription9 Nov 2005
AMOXICILLIN875MGtablet · oralHIKMAPrescription29 Mar 2006
AMOXICILLIN250MG/5ML; 125MG/5MLfor suspension · oralHIKMAPrescription19 Jun 2006
AMOXICILLIN400MG/5ML; 200MG/5MLfor suspension · oralHIKMAPrescription19 Jun 2006
AMOXICILLIN200MG/5ML; 400MG/5MLfor suspension · oralAUROBINDOPrescription28 Dec 2006
AMOXICILLIN250MG; 500MGcapsule · oralHIKMA PHARMSPrescription5 Feb 2007
AMOXICILLIN200MG/5ML; 400MG/5MLfor suspension · oralSANDOZPrescription26 Mar 2007
AMOXICILLIN125MG/5ML; 250MG/5MLfor suspension · oralSANDOZPrescription26 Mar 2007
AMOXICILLIN400MG/5MLfor suspension · oralCHARTWELL RXPrescription18 Jun 2007
AMOXICILLIN125MG/5ML; 250MG/5MLfor suspension · oralAUROBINDO PHARMA LTDPrescription15 Sep 2014
AMOXICILLIN250MG; 500MGcapsule · oralMICRO LABSPrescription24 Jun 2022

49 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
AG-AMOXICILLIN02477726500 MGCAPSULE · ORALANGITA PHARMA INC.
AG-AMOXICILLIN02537451250 MG / 5 MLPOWDER FOR SUSPENSION · ORALANGITA PHARMA INC.
AMOXICILLIN02352753250 MG / 5 MLGRANULES FOR SUSPENSION · ORALSANIS HEALTH INC
AMOXICILLIN02352788250 MG / 5 MLGRANULES FOR SUSPENSION · ORALSANIS HEALTH INC
AMOXICILLIN02401509500 MGCAPSULE · ORALSIVEM PHARMACEUTICALS ULC
AMOXICILLIN02401541250 MG / 5 MLGRANULES FOR SUSPENSION · ORALSIVEM PHARMACEUTICALS ULC
AMOXICILLIN CAPSULES BP02525348250 MGCAPSULE · ORALSANIS HEALTH INC
AMOXICILLIN CAPSULES BP02525356500 MGCAPSULE · ORALSANIS HEALTH INC
APO-AMOXI00628115250 MGCAPSULE · ORALAPOTEX INC
APO-AMOXI00628123500 MGCAPSULE · ORALAPOTEX INC
APO-AMOXI00628131125 MG / 5 MLPOWDER FOR SUSPENSION · ORALAPOTEX INC
APO-AMOXI00628158250 MG / 5 MLPOWDER FOR SUSPENSION · ORALAPOTEX INC
AURO-AMOXICILLIN02388073250 MGCAPSULE · ORALAURO PHARMA INC
AURO-AMOXICILLIN02388081500 MGCAPSULE · ORALAURO PHARMA INC
AURO-AMOXICILLIN02458586125 MG / 5 MLPOWDER FOR SUSPENSION · ORALAURO PHARMA INC
AURO-AMOXICILLIN02458594250 MG / 5 MLPOWDER FOR SUSPENSION · ORALAURO PHARMA INC
JAMP-AMOXICILLIN02433060250 MGCAPSULE · ORALJAMP PHARMA CORPORATION
JAMP-AMOXICILLIN02433079500 MGCAPSULE · ORALJAMP PHARMA CORPORATION
JAMP-AMOXICILLIN02535793125 MG / 5 MLPOWDER FOR SUSPENSION · ORALJAMP PHARMA CORPORATION
JAMP-AMOXICILLIN02535815250 MG / 5 MLPOWDER FOR SUSPENSION · ORALJAMP PHARMA CORPORATION
NOVAMOXIN00406716500 MGCAPSULE · ORALTEVA CANADA LIMITED
NOVAMOXIN00406724250 MGCAPSULE · ORALTEVA CANADA LIMITED
NOVAMOXIN00452130250 MG / 5 MLGRANULES FOR SUSPENSION · ORALTEVA CANADA LIMITED
NOVAMOXIN01934163250 MG / 5 MLGRANULES FOR SUSPENSION · ORALTEVA CANADA LIMITED
NOVAMOXIN02036355250 MGTABLET (CHEWABLE) · ORALTEVA CANADA LIMITED

6 more — full table

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACAMOXICILLIN 125 MG TAB CHEW$0.20766per EA23 Sep 2026
US NADACAMOXICILLIN 125 MG/5 ML SUSP$0.02112per ML23 Sep 2026
US NADACAMOXICILLIN 125 MG/5 ML SUSP$0.01757per ML23 Sep 2026
US NADACAMOXICILLIN 125 MG/5 ML SUSP$0.0228per ML23 Sep 2026
US NADACAMOXICILLIN 200 MG/5 ML SUSP$0.03621per ML23 Sep 2026
US NADACAMOXICILLIN 200 MG/5 ML SUSP$0.03944per ML23 Sep 2026
US NADACAMOXICILLIN 200 MG/5 ML SUSP$0.039per ML23 Sep 2026
US NADACAMOXICILLIN 250 MG CAPSULE$0.06871per EA23 Sep 2026
US NADACAMOXICILLIN 250 MG TAB CHEW$0.30445per EA23 Sep 2026
US NADACAMOXICILLIN 250 MG/5 ML SUSP$0.02438per ML23 Sep 2026
US NADACAMOXICILLIN 250 MG/5 ML SUSP$0.03044per ML23 Sep 2026
US NADACAMOXICILLIN 250 MG/5 ML SUSP$0.02452per ML23 Sep 2026
NHS Drug TariffAmoxicillin 125mg/5ml oral suspension£1.00100 ml1 Oct 2026
NHS Drug TariffAmoxicillin 125mg/5ml oral suspension sugar free£0.98100 ml1 Oct 2026
NHS Drug TariffAmoxicillin 250mg capsules£0.8015 capsule1 Oct 2026
NHS Drug TariffAmoxicillin 250mg capsules£1.1221 capsule1 Oct 2026
NHS Drug TariffAmoxicillin 250mg/5ml oral suspension£1.50100 ml1 Oct 2026
NHS Drug TariffAmoxicillin 250mg/5ml oral suspension sugar free£1.49100 ml1 Oct 2026
NHS Drug TariffAmoxicillin 3g oral powder sachets sugar free£54.742 sachet1 Oct 2026
NHS Drug TariffAmoxicillin 500mg capsules£0.8515 capsule1 Oct 2026
NHS Drug TariffAmoxicillin 500mg capsules£1.1921 capsule1 Oct 2026
NHS Drug TariffAmoxicillin 500mg powder for solution for injection vials£12.0010 vial1 Oct 2026
NHS Drug TariffAmoxicillin 500mg/5ml oral suspension sugar free£9.40100 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)

  • 6.2.1. Access group antibiotics · core
    First choice: Acute pharyngitis; First choice: Periapical abscess without sinus; First choice: Acute sinusitis; First choice: Acute otitis media; First choice: Chronic obstructive pulmonary disease with acute exacerbation; First choice: Acute malnutrition in infants, children or adolescents (uncomplicated) [children]; First choice: Acute malnutrition in infants, children or adolescents (complicated) [children]; First choice: Bacterial pneumonia (Community-acquired pneumonia - mild to moderate); First choice: Bacterial pneumonia (Community-acquired pneumonia - severe) [children]; First choice: Sepsis without septic shock (co-prescribed with gentamicin); Second choice: Bacterial meningitis
    Oral > Liquid: 125 mg per 5 mL (as trihydrate) powder for oral liquid (EMLc); 250 mg per 5 mL (as trihydrate) powder for oral liquid (EMLc) | Parenteral > General injections > unspecified: 250 mg in vial (as sodium) powder for injection; 500 mg in vial (as sodium) powder for injection; 1 g in vial (as sodium) powder for injection | Oral > Solid > dispersible tablet: 250 mg (scored) (as trihydrate) (EMLc); 500 mg (scored) (as trihydrate) (EMLc) | Oral > Solid > dosage form: 250 mg (as trihydrate); 500 mg (as trihydrate) | Parenteral > General injections > unspecified: 250 mg in vial (as sodium) powder for injection (EMLc); 500 mg in vial (as sodium) powder for injection (EMLc); 1 g in vial (as sodium) powder for injection (EMLc) | Oral > Solid > dosage form: 250 mg (as trihydrate) (EMLc); 500 mg (as trihydrate) (EMLc) | Oral > Solid > dosage form: 250 mg (as trihydrate); 500 mg (as trihydrate); 1 g (as trihydrate) (EML)
  • 5.1.6.1. Medicines for bacterial central nervous system infections · core
    Second choice: Bacterial meningitis
    Oral > Liquid: 125 mg per 5 mL (as trihydrate) powder for oral liquid (EMLc); 250 mg per 5 mL (as trihydrate) powder for oral liquid (EMLc) | Parenteral > General injections > unspecified: 250 mg in vial (as sodium) powder for injection; 500 mg in vial (as sodium) powder for injection; 1 g in vial (as sodium) powder for injection | Oral > Solid > dispersible tablet: 250 mg (scored) (as trihydrate) (EMLc); 500 mg (scored) (as trihydrate) (EMLc) | Oral > Solid > dosage form: 250 mg (as trihydrate); 500 mg (as trihydrate)

Safety signals and safety-related labeling changes

  • US FDA 17 Jul 2026 AUGMENTIN '125' — safety-related labeling change
    Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 17 Jul 2026 AUGMENTIN '125' — safety-related labeling change
    Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 17 Jul 2026 AUGMENTIN '200' — safety-related labeling change
    Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 17 Jul 2026 AUGMENTIN '200' — safety-related labeling change
    Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 17 Jul 2026 AUGMENTIN '250' — safety-related labeling change
    Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 17 Jul 2026 AUGMENTIN '250' — safety-related labeling change
    Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 17 Jul 2026 AUGMENTIN '250' — safety-related labeling change
    Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 17 Jul 2026 AUGMENTIN '400' — safety-related labeling change
    Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 17 Jul 2026 AUGMENTIN '400' — safety-related labeling change
    Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 17 Jul 2026 AUGMENTIN '500' — safety-related labeling change
    Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 17 Jul 2026 AUGMENTIN '875' — safety-related labeling change
    Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 17 Jul 2026 AUGMENTIN ES-600 — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 17 Jul 2026 AUGMENTIN XR — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • EMA PRAC 7 May 2026 PRAC signal: Encephalopathy
    Action for MAH: update of the product information: No
  • EMA PRAC 7 May 2026 PRAC signal: Encephalopathy
    Action for MAH: update of the product information: No

All safety entries for amoxicillin →

Combinations containing Amoxicillin

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.