Amoxicillin
Amoxicillin, Amoxicillin /, Amoxicillin / /, Amoxil, Augmentin, Larotid, 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
Combinations
Augmentin, Talicia, Voquezna dual, Voquezna triple (generic drugs available since 1982-01-01, discontinued: 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 | GSK | N-050459 DISCN | 1982-01-01 | 2 products, RLD |
| AMOXIL | GSK | N-050460 DISCN | 1982-01-01 | 3 products, RLD |
| LAROTID | GSK | N-050460 DISCN | 1982-01-01 | 1 products, RLD |
| MOXATAG | Pragma Pharmaceuticals | N-050813 DISCN | 2008-01-23 | 1 products, RLD |
| AMOXIL | USAntibiotics | N-050542 DISCN | 1982-01-01 | 2 products, RLD |
| AMOXIL | USAntibiotics | N-050754 DISCN | 1998-07-10 | 2 products, RLD |
| AMOXIL | USAntibiotics | N-050760 DISCN | 1999-04-15 | 2 products, RLD |
| AMOXIL | USAntibiotics | N-050761 DISCN | 1999-04-15 | 2 products |
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Amoxicillin
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Clarithromycin
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Lansoprazole
Amoxicillin
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Clarithromycin
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Omeprazole
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN | Cumberland Pharmaceuticals | N-050824 DISCN | 2011-02-08 | 1 products, RLD |
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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
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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Vonoprazan fumarate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| VOQUEZNA DUAL PAK | Phathom Pharmaceuticals | N-215153 RX | 2022-05-03 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| amoclan | 2009-01-07 | |
| amoxicillin | ANDA | 2024-02-14 |
| amoxicillin 500 mg | ANDA | 2022-12-20 |
| amoxicillin amoxicillin and clavulanate potassium | ANDA | 2024-01-09 |
| amoxicillin and clavulanate potassium | ANDA | 2024-02-13 |
| 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 oral susp | ANDA | 2022-08-08 |
| amoxil | ANDA | 2023-01-12 |
Show 10 more
Indications
FDA
EMA
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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
927 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 | — | 7 | 8 | 27 | 102 | 56 | 193 |
| Pneumonia | D011014 | EFO_0003106 | — | 4 | 4 | 10 | 12 | 12 | 39 |
| Gastritis | D005756 | EFO_0000217 | K29.7 | 1 | 3 | 7 | 11 | 4 | 24 |
| Helicobacter infections | D016481 | EFO_1000961 | — | — | 2 | 6 | 8 | 8 | 23 |
| Healthy volunteers/patients | — | — | — | 12 | 1 | 1 | 2 | 6 | 22 |
| Helicobacter pylori | D016480 | NCBITaxon_210 | B96.81 | 2 | 1 | 4 | 12 | 2 | 20 |
| Sinusitis | D012852 | EFO_0007486 | J32 | — | — | 4 | 7 | 5 | 16 |
| Appendicitis | D001064 | EFO_0007149 | K37 | — | 1 | 1 | 2 | 12 | 16 |
| Dyspepsia | D004415 | EFO_0008533 | K30 | 1 | 2 | 2 | 9 | 1 | 15 |
| Bacterial infections | D001424 | — | A49 | 3 | 1 | 1 | 5 | 4 | 14 |
Show 97 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | — | 2 | 2 | — | 2 | 6 |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | 1 | 1 | 1 | — | 1 | 4 |
| Intraabdominal infections | D059413 | — | — | — | — | 4 | — | — | 4 |
| Bacterial pneumonia | D018410 | EFO_1001272 | J15.9 | — | 1 | 3 | — | — | 4 |
| Sepsis | D018805 | HP_0100806 | A41.9 | — | — | 1 | — | 3 | 4 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | — | — | 1 | — | 3 | 4 |
| Periodontal pocket | D010514 | EFO_1001393 | — | — | — | 2 | — | 1 | 3 |
| Febrile neutropenia | D064147 | — | — | — | — | 2 | — | 1 | 3 |
| Neutropenia | D009503 | — | D70 | — | — | 2 | — | 1 | 3 |
| Neoplasms | D009369 | — | C80 | — | — | 2 | — | 1 | 3 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pulmonary tuberculosis | D014397 | EFO_1000049 | A15 | — | 6 | — | — | — | 6 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | 3 | — | — | — | 3 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 1 | 1 | — | — | 2 | 3 |
| Insulin resistance | D007333 | HP_0000855 | E88.819 | — | 1 | — | — | 1 | 2 |
| Empyema | D004653 | EFO_0003097 | — | — | 1 | — | — | 1 | 2 |
| Tonsillectomy | D014068 | — | — | 1 | 1 | — | — | 1 | 2 |
| Asthma | D001249 | EFO_0000270 | J45 | — | 1 | — | — | — | 1 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | — | 1 | — | — | — | 1 |
| Fatty liver | D005234 | EFO_0003934 | — | — | 1 | — | — | — | 1 |
| Colorectal neoplasms | D015179 | — | — | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Drug interactions | D004347 | — | — | 2 | — | — | — | — | 2 |
| Gastrointestinal diseases | D005767 | — | — | 1 | — | — | — | 1 | 2 |
| Respiratory tract diseases | D012140 | — | — | 2 | — | — | — | — | 2 |
| Jaw fractures | D007572 | — | — | 1 | — | — | — | — | 1 |
| Inflammation | D007249 | MP_0001845 | — | 1 | — | — | — | — | 1 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 1 | — | — | — | — | 1 |
| Glioblastoma | D005909 | EFO_0000515 | — | 1 | — | — | — | — | 1 |
| Astrocytoma | D001254 | EFO_0000271 | — | 1 | — | — | — | — | 1 |
| Erectile dysfunction | D007172 | EFO_0004234 | F52.21 | 1 | — | — | — | — | 1 |
| Short bowel syndrome | D012778 | — | K90.82 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Malaria | D008288 | EFO_0001068 | B54 | — | — | — | — | 3 | 3 |
| Kwashiorkor | D007732 | EFO_1001009 | E40 | — | — | — | — | 3 | 3 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | — | — | — | 2 | 2 |
| Bisphosphonate-associated osteonecrosis of the jaw | D059266 | — | — | — | — | — | — | 2 | 2 |
| Chemical and drug induced liver injury | D056486 | EFO_0004228 | — | — | — | — | — | 2 | 2 |
| Renal dialysis | D006435 | EFO_0010690 | Z99.2 | — | — | — | — | 2 | 2 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | — | 2 | 2 |
| Bronchiectasis | D001987 | HP_0002110 | J47 | — | — | — | — | 2 | 2 |
| Bone resorption | D001862 | — | — | — | — | — | — | 2 | 2 |
| Pregnancy complications | D011248 | — | — | — | — | — | — | 2 | 2 |
Show 74 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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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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Clarithromycin
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Amoxicillin
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Clavulanate
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Safety
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57,010 adverse events reported
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