Amoxicillin
Amoxicillin, Amoxicillin /, Amoxicillin / /, Amoxil, Augmentin, Larotid, Omeclamox-pak, Talicia, Voquezna (amoxicillin) is a small molecule pharmaceutical. Amoxicillin was first approved as Amoxil on 1982-01-01. It is used to treat actinomycosis, bacterial infections, bacterial skin diseases, chlamydia infections, and duodenal ulcer amongst others in the USA.
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Commercial
Trade Name
FDA
EMA
Amoxicillin, Amoxil (discontinued: Amoxicillin, Amoxil, Dispermox, Larotid, Moxatag, Polymox, Trimox, Utimox, Wymox)
CombinationsAmoxicillin clavulanate potassium, Augmentin, Lansoprazole, amoxicillin clarithromycin, Talicia, Voquezna dual, Voquezna triple (discontinued: Amoxicillin clavulanate potassium, Augmentin, Lansoprazole, amoxicillin clarithromycin, Omeclamox-pak, Prevpac)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Amoxicillin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| AMOXIL | USAntibiotics | N-050760 RX | 1999-04-15 | 1 products, RLD |
Show 8 discontinued
Amoxicillin
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Clarithromycin
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Lansoprazole
Amoxicillin
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Omeprazole magnesium
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Rifabutin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TALICIA | RedHill Biopharma | N-213004 RX | 2019-11-01 | 1 products, RLD, RS |
Amoxicillin
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Clarithromycin
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Omeprazole
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| OMECLAMOX-PAK | Cumberland Pharmaceuticals | N-050824 DISCN | 2011-02-08 | 1 products, RLD |
Hide discontinued
Amoxicillin
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Vonoprazan fumarate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| VOQUEZNA DUAL PAK | Phathom Pharmaceuticals | N-215153 RX | 2022-05-03 | 1 products, RLD, RS |
Amoxicillin
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Clarithromycin
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Vonoprazan fumarate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| VOQUEZNA TRIPLE PAK | Phathom Pharmaceuticals | N-215152 RX | 2022-05-03 | 1 products, RLD, RS |
Amoxicillin
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Clavulanate potassium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| AUGMENTIN '125' | USAntibiotics | N-050575 RX | 1984-08-06 | 1 products, RLD |
| AUGMENTIN '250' | USAntibiotics | N-050575 RX | 1984-08-06 | 1 products, RLD, RS |
| AUGMENTIN '875' | USAntibiotics | N-050720 RX | 1996-02-13 | 1 products, RLD |
| AUGMENTIN ES-600 | USAntibiotics | N-050755 RX | 2001-06-22 | 1 products, RLD |
Show 9 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| amoclan | 2009-01-07 | |
| amoxicillin | NDA authorized generic | 2025-12-04 |
| amoxicillin 500 mg | ANDA | 2025-01-14 |
| amoxicillin amoxicillin and clavulanate potassium | ANDA | 2024-01-09 |
| amoxicillin and clavulanate potassium | ANDA | 2025-11-20 |
| amoxicillin and clavulanate potassium extended release | New Drug Application | 2011-04-07 |
| amoxicillin clav/pot amoxicillin/clav pot | ANDA | 2023-04-20 |
| amoxicillin clavulanate potassium | 2006-11-03 | |
| amoxicillin/clav pot | ANDA | 2025-08-01 |
| amoxicillin/clav pot oral susp | ANDA | 2025-01-22 |
Show 11 more
Indications
FDA
EMA
Show 20 more
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
AMOXICILLIN / CLARITHROMYCIN / VONOPRAZAN FUMARATE, VOQUEZNA TRIPLE PAK, PHATHOM | |||
| 2032-05-03 | GAIN | ||
| 2027-05-03 | NCE | ||
AMOXICILLIN / VONOPRAZAN FUMARATE, VOQUEZNA DUAL PAK, PHATHOM | |||
| 2032-05-03 | GAIN | ||
| 2027-05-03 | NCE | ||
AMOXICILLIN / OMEPRAZOLE MAGNESIUM / RIFABUTIN, TALICIA, REDHILL | |||
| 2027-11-01 | GAIN | ||
| 2022-11-01 | NP | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Amoxicillin / Omeprazole Magnesium / Rifabutin, Talicia, Redhill | |||
| 11878011 | 2042-05-27 | U-3816 | |
| 9050263 | 2034-02-12 | DP | U-2660 |
| 9498445 | 2034-02-12 | DP | U-2660 |
| 9603806 | 2034-02-12 | DP | U-2660 |
| 10238606 | 2034-02-12 | DP | |
| 11135172 | 2034-02-12 | DP | U-2660 |
| Amoxicillin / Clarithromycin / Vonoprazan Fumarate, Voquezna Triple Pak, Phathom | |||
| 9186411 | 2030-08-11 | DP | |
| 7977488 | 2028-08-11 | DP | |
| Amoxicillin, Moxatag, Pragma | |||
| 8299052 | 2027-05-07 | U-1304 | |
| 8357394 | 2026-12-08 | DP | |
| 8778924 | 2026-12-08 | DS, DP | U-897 |
ATC Codes
A: Alimentary tract and metabolism drugs
— A02: Drugs for acid related disorders
— A02B: Drugs for peptic ulcer and gastro-oesophageal reflux disease (gord)
— A02BD: Combinations for eradication of helicobacter pylori
— A02BD01: Omeprazole, amoxicillin and metronidazole
— A02BD03: Lansoprazole, amoxicillin and metronidazole
— A02BD04: Pantoprazole, amoxicillin and clarithromycin
— A02BD05: Omeprazole, amoxicillin and clarithromycin
— A02BD06: Esomeprazole, amoxicillin and clarithromycin
— A02BD07: Lansoprazole, amoxicillin and clarithromycin
— A02BD10: Lansoprazole, amoxicillin and levofloxacin
— A02BD11: Pantoprazole, amoxicillin, clarithromycin and metronidazole
— A02BD12: Rabeprazole, amoxicillin and clarithromycin
— A02BD13: Rabeprazole, amoxicillin and metronidazole
— A02BD14: Vonoprazan, amoxicillin and clarithromycin
— A02BD15: Vonoprazan, amoxicillin and metronidazole
— A02BD16: Omeprazole, amoxicillin and rifabutin
J: Antiinfectives for systemic use
— J01: Antibacterials for systemic use
— J01C: Beta-lactam antibacterials, penicillins
— J01CA: Penicillins with extended spectrum
— J01CA04: Amoxicillin
— J01CR: Combinations of penicillins, incl. beta-lactamase inhibitors
— J01CR02: Amoxicillin and beta-lactamase inhibitor
HCPCS
Code | Description |
|---|---|
| G9313 | Amoxicillin, with or without clavulanate, not prescribed as first line antibiotic at the time of diagnosis for documented reason |
| G9314 | Amoxicillin, with or without clavulanate, not prescribed as first line antibiotic at the time of diagnosis, reason not given |
| G9315 | Amoxicillin, with or without clavulanate, prescribed as a first line antibiotic at the time of diagnosis |
Clinical
Clinical Trials
1014 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | — | 15 | 26 | 62 | 157 | 104 | 345 |
| Helicobacter infections | D016481 | EFO_1000961 | — | 7 | 15 | 26 | 65 | 50 | 154 |
| Communicable diseases | D003141 | — | — | 1 | 6 | 27 | 54 | 42 | 126 |
| Pneumonia | D011014 | EFO_0003106 | J18 | 4 | 8 | 20 | 22 | 18 | 66 |
| Gastritis | D005756 | EFO_0000217 | K29.7 | 3 | 3 | 13 | 37 | 9 | 63 |
| Periodontitis | D010518 | EFO_0000649 | K05.3 | 1 | 5 | 6 | 11 | 18 | 38 |
| Sinusitis | D012852 | EFO_0007486 | J32 | — | 1 | 7 | 15 | 8 | 31 |
| Dyspepsia | D004415 | EFO_0008533 | K30 | 1 | 3 | 3 | 16 | 5 | 28 |
| Healthy volunteers/patients | — | — | — | 14 | 1 | 1 | 3 | 7 | 26 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 1 | 1 | 4 | 8 | 6 | 20 |
Show 186 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | — | 5 | 4 | — | 5 | 12 |
| Neoplasms | D009369 | — | C80 | 1 | 3 | 5 | — | 1 | 7 |
| Neutropenia | D009503 | — | D70 | — | — | 4 | — | 2 | 6 |
| Malaria | D008288 | EFO_0001068 | B54 | — | — | 1 | — | 4 | 5 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | — | 4 | 1 | — | — | 5 |
| Intraabdominal infections | D059413 | — | — | — | — | 5 | — | — | 5 |
| Covid-19 | D000086382 | — | U07.1 | — | — | 2 | — | 2 | 4 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | 1 | — | 3 | 4 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | — | 1 | 2 | — | 2 | 4 |
| Periodontal pocket | D010514 | EFO_1001393 | — | — | — | 2 | — | 1 | 3 |
Show 68 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| B-cell lymphoma marginal zone | D018442 | — | C88.4 | — | 1 | — | — | 4 | 5 |
| Pulmonary tuberculosis | D014397 | EFO_1000049 | A15 | — | 5 | — | — | — | 5 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | 4 | — | — | — | 4 |
| Fatty liver | D005234 | EFO_0003934 | — | — | 4 | — | — | — | 4 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 1 | 1 | — | — | 3 | 4 |
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | — | 1 | — | — | 1 | 2 |
| Colorectal neoplasms | D015179 | — | — | — | 1 | — | — | 1 | 2 |
| Empyema | D004653 | EFO_0003097 | — | — | 1 | — | — | 1 | 2 |
| B-cell lymphoma | D016393 | — | — | — | 1 | — | — | 1 | 2 |
| Tonsillectomy | D014068 | — | — | 1 | 1 | — | — | 1 | 2 |
Show 23 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chemical and drug induced liver injury | D056486 | EFO_0004228 | — | 1 | — | — | — | 2 | 3 |
| Atrophy | D001284 | — | — | 1 | — | — | — | 2 | 3 |
| Pregnancy rate | D018873 | — | — | 1 | — | — | — | 1 | 2 |
| Drug interactions | D004347 | — | — | 2 | — | — | — | — | 2 |
| Respiration disorders | D012120 | — | J00-J99 | 2 | — | — | — | — | 2 |
| Bone regeneration | D001861 | — | — | 1 | — | — | — | 1 | 2 |
| Jaw fractures | D007572 | — | — | 1 | — | — | — | — | 1 |
| Gastrointestinal motility | D005769 | — | — | 1 | — | — | — | — | 1 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 1 | — | — | — | — | 1 |
| Glioblastoma | D005909 | EFO_0000515 | — | 1 | — | — | — | — | 1 |
Show 6 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Kwashiorkor | D007732 | EFO_1001009 | E40 | — | — | — | — | 4 | 4 |
| Gastrointestinal microbiome | D000069196 | — | — | — | — | — | — | 3 | 3 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | — | — | — | 2 | 2 |
| Bisphosphonate-associated osteonecrosis of the jaw | D059266 | — | — | — | — | — | — | 2 | 2 |
| Arthritis | D001168 | EFO_0005856 | M05-M14 | — | — | — | — | 2 | 2 |
| Renal insufficiency | D051437 | — | N19 | — | — | — | — | 2 | 2 |
| Renal dialysis | D006435 | EFO_0010690 | Z99.2 | — | — | — | — | 2 | 2 |
| Enterococcus | D016983 | — | — | — | — | — | — | 2 | 2 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | — | 2 | 2 |
| Bronchiectasis | D001987 | — | J47 | — | — | — | — | 2 | 2 |
Show 115 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Amoxicillin |
| INN | amoxicillin |
| Description | Amoxicillin is a penicillin in which the substituent at position 6 of the penam ring is a 2-amino-2-(4-hydroxyphenyl)acetamido group. It has a role as an antibacterial drug. It is a penicillin and a penicillin allergen. It is a conjugate acid of an amoxicillin(1-). |
| Classification | Small molecule |
| Drug class | penicillins |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC1(C)S[C@@H]2[C@H](NC(=O)[C@H](N)c3ccc(O)cc3)C(=O)N2[C@H]1C(=O)O |
Identifiers
| PDB | — |
| CAS-ID | 26787-78-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1082 |
| ChEBI ID | 2676 |
| PubChem CID | 33613 |
| DrugBank | DB01060 |
| UNII ID | 9EM05410Q9 (ChemIDplus, GSRS) |
Target
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Estimated US medical usage
Amoxicillin
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Amoxicillin
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Lansoprazole
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Clarithromycin
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Amoxicillin
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Omeprazole
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Clarithromycin
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Amoxicillin
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Clavulanic acid
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Safety
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72,127 adverse events reported
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