Ampicillin
Ampicillin, Unasyn (ampicillin) is a small molecule pharmaceutical. Ampicillin was first approved as Polycillin-n on 1982-01-01. It is used to treat actinomycosis, bacillary dysentery, bacterial endocarditis, bacterial infections, and bacterial meningitis amongst others in the USA.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Combinations
Unasyn (generic drugs available since 1982-01-01)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ampicillin sodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| POLYCILLIN-N | Bristol Myers Squibb | N-050309 DISCN | 1982-01-01 | 5 products |
| PENBRITIN-S | Wyeth | N-050072 DISCN | 1982-01-01 | 6 products, RLD |
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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ampicillin | ANDA | 2024-02-02 |
| ampicillin ampicillin sodium | ANDA | 2023-11-10 |
| ampicillin and sulbactam | ANDA | 2024-02-14 |
| ampicillin sodium | ANDA | 2023-05-03 |
| ampicillin sodium and sulbactam sodium | ANDA | 2023-07-21 |
| unasyn | New Drug Application | 2023-11-06 |
Indications
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Agency Specific
FDA
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Patent Expiration
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ATC Codes
J: Antiinfectives for systemic use
— J01: Antibacterials for systemic use
— J01C: Beta-lactam antibacterials, penicillins
— J01CA: Penicillins with extended spectrum
— J01CA01: Ampicillin
— J01CA51: Ampicillin, combinations
— J01CR: Combinations of penicillins, incl. beta-lactamase inhibitors
— J01CR01: Ampicillin and beta-lactamase inhibitor
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01A: Antiinfective ophthalmologics
— S01AA: Antibiotics, ophthalmologic
— S01AA19: Ampicillin
Clinical
Clinical Trials
136 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pneumonia | D011014 | EFO_0003106 | — | — | 2 | 3 | 3 | 5 | 11 |
| Syphilis | D013587 | EFO_0007504 | A53.9 | 1 | 2 | 4 | 2 | — | 8 |
| Urinary tract infections | D014552 | EFO_0003103 | N39.0 | — | — | — | 3 | 3 | 6 |
| Appendicitis | D001064 | EFO_0007149 | K37 | — | — | — | 2 | 3 | 5 |
| Infections | D007239 | EFO_0000544 | — | 1 | — | 1 | 1 | 1 | 4 |
| Bacteremia | D016470 | EFO_0003033 | R78.81 | — | 1 | — | 2 | 1 | 4 |
| Neonatal sepsis | D000071074 | HP_0040187 | — | — | 2 | 1 | 1 | 1 | 4 |
| Yaws | D015001 | EFO_0007548 | A66 | — | — | 2 | 1 | — | 3 |
| Intraabdominal infections | D059413 | — | — | — | 1 | 1 | 2 | — | 3 |
| Necrotizing enterocolitis | D020345 | EFO_0003928 | K55.3 | — | 1 | — | 1 | 1 | 3 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sepsis | D018805 | HP_0100806 | A41.9 | — | 1 | 2 | — | 1 | 4 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 1 | 2 | — | 2 | 4 |
| Chorioamnionitis | D002821 | — | O41.12 | — | 2 | 2 | — | 1 | 3 |
| Neurosyphilis | D009494 | EFO_0007339 | A50.4 | — | — | 1 | — | 1 | 2 |
| Lung abscess | D008169 | EFO_1001362 | J85.2 | — | — | 1 | — | 1 | 2 |
| Premature birth | D047928 | EFO_0003917 | O60 | — | — | 1 | — | 1 | 2 |
| Ebola hemorrhagic fever | D019142 | EFO_0007243 | A98.4 | — | 1 | 1 | — | — | 1 |
| Enterobacteriaceae infections | D004756 | EFO_1001313 | — | — | — | 1 | — | — | 1 |
| Community-acquired infections | D017714 | — | — | — | 1 | 1 | — | — | 1 |
| Treponemal infections | D014211 | EFO_1001217 | — | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Rheumatic heart disease | D012214 | EFO_1001161 | I09.9 | — | 2 | — | — | 2 | 4 |
| Psoriasis | D011565 | EFO_0000676 | L40 | — | 1 | — | — | 1 | 2 |
| Cerebral intraventricular hemorrhage | D000074042 | — | — | — | 1 | — | — | — | 1 |
| Bronchopulmonary dysplasia | D001997 | — | P27.8 | — | 1 | — | — | — | 1 |
| Periventricular leukomalacia | D007969 | EFO_1001101 | P91.2 | — | 1 | — | — | — | 1 |
| Cleft palate | D002972 | HP_0000175 | Q35 | — | 1 | — | — | — | 1 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Osteomyelitis | D010019 | EFO_0003102 | M86 | 1 | — | — | — | — | 1 |
| Jaw fractures | D007572 | — | — | 1 | — | — | — | — | 1 |
| Dystonia | D004421 | HP_0001332 | G24 | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bacterial infections | D001424 | — | A49 | — | — | — | — | 2 | 2 |
| Salmonella infections | D012480 | EFO_1001418 | A02.9 | — | — | — | — | 1 | 1 |
| Endometritis | D004716 | EFO_1001312 | — | — | — | — | — | 1 | 1 |
| Acute cholecystitis | D041881 | EFO_1001289 | K81.0 | — | — | — | — | 1 | 1 |
| Premature rupture fetal membranes | D005322 | HP_0001788 | O42 | — | — | — | — | 1 | 1 |
| Hepatitis c | D006526 | — | B19.2 | — | — | — | — | 1 | 1 |
| Chronic hepatitis c | D019698 | EFO_0004220 | B18.2 | — | — | — | — | 1 | 1 |
| Asymptomatic infections | D058345 | — | — | — | — | — | — | 1 | 1 |
| Bacteriuria | D001437 | — | R82.71 | — | — | — | — | 1 | 1 |
| Psoriatic arthritis | D015535 | EFO_0003778 | L40.5 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Ampicillin |
| INN | ampicillin |
| Description | Ampicillin is a penicillin in which the substituent at position 6 of the penam ring is a 2-amino-2-phenylacetamido group. It has a role as an antibacterial drug. It is a penicillin, a penicillin allergen and a beta-lactam antibiotic. It is a conjugate acid of an ampicillin(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)c3ccccc3)C(=O)N2[C@H]1C(=O)O |
Identifiers
| PDB | — |
| CAS-ID | 69-53-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL174 |
| ChEBI ID | 28971 |
| PubChem CID | 6249 |
| DrugBank | DB00415 |
| UNII ID | 7C782967RD (ChemIDplus, GSRS) |
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Estimated US medical usage
Ampicillin
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Ampicillin
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Sulbactam
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Safety
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Adverse Events
Top Adverse Reactions
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5,184 adverse events reported
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