Overview
Amoxicillin, or BRL-2333, is a penicillin G derivative first described in the literature in 1972. Amoxicillin has similar activity to penicillin and ampicillin, but leads to higher serum concentrations than ampicillin. Amoxicillin was granted FDA approval on 18 January 1974.
Indication
Amoxicillin alone is indicated to treat susceptible bacterial infections of the ear, nose, throat, genitourinary tract, skin, skin structure, and lower respiratory tract. Amoxicillin is given with calvulanic acid to treat acute bacterial sinusitis, community acquired pneumonia, lower respiratory tract infections, acute bacterial otitis media, skin and skin structure infections, and urinary tract infections. Amoxicillin is given with omeprazole in the treatment of Helicobacter pylori (H. pylori) infection. Amoxicillin is used in combination with vonoprazan and clarithromycin as co-packaged triple therapy or in combination with vonoprazan as co-packaged dual therapy to treat H. pylori infection in adults.
Associated Conditions
- Acute Bacterial Sinusitis (ABS)
- Acute Otitis Media (AOM)
- Bacterial Infections
- Community Acquired Pneumonia (CAP)
- Duodenal ulcer caused by helicobacter pylori
- Genitourinary tract infection
- Helicobacter Pylori Infection
- Lower Respiratory Tract Infection (LRTI)
- Peptic Ulcer With H. Pylori Infection
- Sinusitis
- Skin and Subcutaneous Tissue Bacterial Infections
- Urinary Tract Infection
- Acute, uncomplicated Gonorrhea
- Ear, nose, and throat infections
Research Report
Published: Jul 15, 2025
A Comprehensive Monograph on Amoxicillin: Pharmacology, Clinical Utility, and Safety Profile
Section 1: Drug Identification and Physicochemical Properties
This section serves as the foundational chemical and structural reference for Amoxicillin, consolidating identifiers from numerous international databases to create a single, unambiguous profile of the molecule. This comprehensive identification is essential for accurate research, clinical communication, and regulatory tracking, especially for a drug with such a long and widespread history of use.
1.1 Core Identification
Amoxicillin is a well-established antibiotic agent recognized globally under various nomenclature systems. Its core identifiers provide a standardized method for referencing the compound across scientific literature, clinical databases, and regulatory filings.
- Generic Name: The universally accepted non-proprietary name is Amoxicillin. Variant spellings and Latin forms, such as Amoxicilline and Amoxicillinum, are also documented.[1]
- DrugBank Accession Number: The unique identifier in the DrugBank database is DB01060.[1]
- Drug Type/Modality: Amoxicillin is classified as a Small Molecule drug, indicating it is a low molecular weight organic compound.[1]
- Drug Groups: It holds multiple statuses, being listed as Approved for general medical use, Investigational for ongoing studies into new uses or formulations, and Vet approved for use in veterinary medicine.[1] This broad classification highlights its extensive utility across different fields of medicine.
1.2 Chemical and Structural Data
The precise chemical and structural properties of amoxicillin define its physical characteristics, stability, and, most importantly, its biological activity.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/16 | Not Applicable | Recruiting | Yongquan Shi | ||
2025/05/09 | Phase 3 | Not yet recruiting | |||
2025/04/10 | Phase 2 | Not yet recruiting | |||
2025/03/28 | Early Phase 1 | Not yet recruiting | |||
2025/03/14 | Phase 3 | Active, not recruiting | Hospital de Niños R. Gutierrez de Buenos Aires | ||
2025/03/11 | Not Applicable | Not yet recruiting | |||
2025/02/28 | Not Applicable | Not yet recruiting | Key Laboratory for Gastrointestinal Diseases of Gansu Province | ||
2025/02/12 | Phase 1 | Active, not recruiting | |||
2025/02/06 | Phase 3 | ENROLLING_BY_INVITATION | Chang Gung Memorial Hospital | ||
2025/01/16 | Early Phase 1 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| A-S Medication Solutions | 50090-6355 | ORAL | 400 mg in 5 mL | 12/12/2022 | |
| Proficient Rx LP | 63187-044 | ORAL | 500 mg in 1 1 | 11/1/2018 | |
| Bryant Ranch Prepack | 63629-7798 | ORAL | 500 mg in 1 1 | 12/14/2015 | |
| NuCare Pharmaceuticals,Inc. | 68071-4696 | ORAL | 125 mg in 5 mL | 2/17/2021 | |
| Preferred Pharmaceuticals Inc. | 68788-7958 | ORAL | 875 mg in 1 1 | 2/8/2024 | |
| A-S Medication Solutions | 50090-1814 | ORAL | 250 mg in 5 mL | 6/7/2023 | |
| Direct_Rx | 61919-716 | ORAL | 250 mg in 5 mL | 1/12/2023 | |
| NuCare Pharmaceuticals,Inc. | 68071-2323 | ORAL | 250 mg in 1 1 | 1/6/2021 | |
| Pharmasource Meds, LLC | 82982-069 | ORAL | 875 mg in 1 1 | 5/26/2023 | |
| Aidarex Pharmaceuticals LLC | 33261-726 | ORAL | 250 mg in 5 mL | 3/28/2014 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| BETAMOX GRANULES 125 mg/5 ml | SIN04143P | GRANULE, FOR SUSPENSION | 125 mg/5 ml | 4/20/1990 | |
| MOXICLAV DRY POWDER FOR ORAL SUSPENSION 156.25 mg/5 ml | SIN10690P | POWDER, FOR SUSPENSION | 125 mg/5 ml | 1/20/1999 | |
| CLAMOVID 625 TABLET 625 mg | SIN12026P | TABLET, FILM COATED | 500 mg | 7/17/2002 | |
| AMOXICAP 500 CAPSULE 500 mg | SIN09681P | CAPSULE | 500 mg | 3/19/1998 | |
| STRIMOX-250 CAPSULE 250 mg | SIN11417P | CAPSULE | 250 mg | 10/28/2000 | |
| PULMOXYL DRY SYRUP 125 mg/5ml | SIN11300P | SYRUP | 125 mg/5ml | 4/5/2000 | |
| AMOXIGRAN GRANULES 125 mg/5 ml | SIN07648P | GRANULE, FOR SUSPENSION | 125 mg/5 ml | 2/16/1994 | |
| PULMOXYL - 500 CAPSULE 500 mg (Maroon/yellow) | SIN11190P | CAPSULE | 500.00 mg | 9/24/1999 | |
| AMOXAPEN 250 CAPSULE 250 mg | SIN01607P | CAPSULE | 250 mg | 6/1/1988 | |
| AMOXAPEN 500 CAPSULE 500 mg | SIN01943P | CAPSULE | 500 mg | 6/23/1988 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| NU-AMOXI CAP 250MG | nu-pharm inc | 00865567 | Capsule - Oral | 250 MG | 12/31/1990 |
| AMOXIL 125 ORAL SUSPENSION | ayerst laboratories | 00288500 | Suspension - Oral | 25 MG / ML | 12/31/1974 |
| AMOXIL CAP 500MG | ayerst laboratories | 00330531 | Capsule - Oral | 500 MG / CAP | 12/31/1975 |
| RIVA-AMOXICILLIN 125MG/5ML FOR ORAL SUSPENSION | laboratoire riva inc. | 02240829 | Powder For Solution - Oral | 125 MG / 5 ML | 9/1/1999 |
| AMOXICILLIN | BGP Pharma ULC | 02237154 | Capsule - Oral | 500 MG / CAP | N/A |
| AMOXIL CHEWABLE TABLETS 125MG | wyeth-ayerst canada inc. | 02041685 | Tablet - Oral | 125 MG / TAB | 4/12/1999 |
| AA-LANSOPRAZOLE-AMOXICILLIN-CLARITHROMYCIN | aa pharma inc | 02470780 | Capsule
,
Kit
,
Tablet
,
Capsule (Delayed Release) - Oral | 500 MG / CAP | 8/3/2018 |
| AMOXIL 250 CAP | ayerst laboratories | 00288497 | Capsule - Oral | 250 MG / CAP | 12/31/1974 |
| AMOXIL 250 ORAL SUSPENSION | ayerst laboratories | 00288519 | Suspension - Oral | 50 MG / ML | 12/31/1974 |
| RIVA-AMOXICILLIN 250MG/5ML FOR ORAL SUSPENSION | laboratoire riva inc. | 02240830 | Powder For Solution - Oral | 250 MG / 5 ML | 9/1/1999 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| AMOXICILINA/ACIDO CLAVULANICO ALMUS 875 MG/125 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Almus Farmaceutica S.A.U. | 81204 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| AMOXICILINA/ACIDO CLAVULANICO SUPPORT PHARMA 500 MG/125 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorios Support Pharma S.L. | 87836 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| AMOXICILINA/ACIDO CLAVULANICO SUPPORT PHARMA 875MG/125MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorios Support Pharma S.L. | 87835 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| AMOXICILINA/ACIDO CLAVULANICO CINFA 875 mg/125 mg POLVO PARA SUSPENSION ORAL EN SOBRES EFG | Laboratorios Cinfa S.A. | 66567 | POLVO PARA SUSPENSIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Commercialized |
| AMOXICILINA/ACIDO CLAVULANICO ALMUS 500 MG/125 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Almus Farmaceutica S.A.U. | 81203 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| AMITRON 500 MG CÁPSULAS DURAS | Ldp Laboratorios Torlan S.A. | 54626 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| AMOXICILINA/ACIDO CLAVULANICO CINFA 250 mg /62,5 mg POLVO PARA SUSPENSION ORAL EN SOBRES EFG | Laboratorios Cinfa S.A. | 66565 | POLVO PARA SUSPENSIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Commercialized |
| AMITRON 1 g POLVO PARA SOLUCIÓN INYECTABLE | Ldp Laboratorios Torlan S.A. | 56266 | POLVO PARA SOLUCIÓN INYECTABLE | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| AMOXICILINA/ACIDO CLAVULANICO CENTRIENT 875 MG/125 MG POLVO PARA SUSPENSION ORAL EFG | Centrient Pharmaceuticals Netherlands B.V. | 81571 | POLVO PARA SUSPENSIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| AMITRON 500 MG POLVO PARA SOLUCIÓN INYECTABLE | Ldp Laboratorios Torlan S.A. | 56265 | POLVO PARA SOLUCIÓN INYECTABLE | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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