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
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Ampicillin (discontinued: Ampicillin, Omnipen-n, Penbritin-s, Polycillin-n, Totacillin-n)
CombinationsAmpicillin sulbactam, Ampicillin trihydrate, Unasyn (discontinued: Amcill, Ampicillin sulbactam, Ampicillin trihydrate, Omnipen (ampicillin), Penbritin, Pfizerpen-a, Polycillin, Polycillin-prb, Principen, Principen w/ probenecid, Probampacin, Totacillin, Unasyn)
Drug Products
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EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ampicillin
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Ampicillin trihydrate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PRINCIPEN '250' | Bristol Myers Squibb | N-050056 DISCN | 1982-01-01 | 1 products, RLD |
| PRINCIPEN '500' | Bristol Myers Squibb | N-050056 DISCN | 1982-01-01 | 1 products, RLD |
| POLYCILLIN | Bristol Myers Squibb | N-050093 DISCN | 1982-01-01 | 1 products |
| POLYCILLIN | Bristol Myers Squibb | N-050308 DISCN | 1982-01-01 | 4 products |
| POLYCILLIN | Bristol Myers Squibb | N-050310 DISCN | 1982-01-01 | 2 products |
| PENBRITIN | Wyeth | N-050019 DISCN | 1982-01-01 | 3 products |
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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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Ampicillin sodium
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Sulbactam sodium
Ampicillin
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Ampicillin trihydrate
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Probenecid
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PRINCIPEN W/ PROBENECID | Bristol Myers Squibb | N-050488 DISCN | 1982-01-01 | 1 products |
| POLYCILLIN-PRB | Bristol Myers Squibb | N-050457 DISCN | 1982-01-01 | 1 products |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ampicillin | ANDA | 2025-11-17 |
| ampicillin ampicillin sodium | ANDA | 2023-11-10 |
| ampicillin and sulbactam | ANDA | 2025-11-04 |
| ampicillin sodium | ANDA | 2025-10-02 |
| ampicillin sodium and sulbactam sodium | ANDA | 2025-11-28 |
| unasyn | New Drug Application | 2025-05-14 |
Indications
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Agency Specific
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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
930 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 | — | — | — | — | 3 | — | 3 |
| Communicable diseases | D003141 | — | — | — | — | — | 3 | — | 3 |
| Respiratory tract infections | D012141 | — | J06.9 | 2 | — | — | 1 | — | 3 |
| Otitis media | D010033 | EFO_0004992 | H66.9 | — | — | — | 1 | 1 | 2 |
| Otitis | D010031 | — | — | — | — | — | 1 | 1 | 2 |
| Ventilator-associated pneumonia | D053717 | EFO_1001865 | J95.851 | — | — | — | 1 | — | 1 |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | — | — | 1 | — | 1 |
| Dental focal infection | D005491 | — | — | — | — | — | 1 | — | 1 |
| Focal infection | D005490 | — | — | — | — | — | 1 | — | 1 |
| Infectious skin diseases | D012874 | — | — | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sinusitis | D012852 | EFO_0007486 | J32 | — | — | 1 | — | — | 1 |
| Rhinosinusitis | D000096825 | — | — | — | — | 1 | — | — | 1 |
| Neutropenia | D009503 | — | D70 | — | — | 1 | — | — | 1 |
| Neoplasms | D009369 | — | C80 | — | — | 1 | — | — | 1 |
| Fever | D005334 | — | R50.9 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bacterial infections | D001424 | — | A49 | 1 | 1 | — | — | 1 | 3 |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | — | 1 | — | — | — | 1 |
| Pulmonary tuberculosis | D014397 | EFO_1000049 | A15 | — | 1 | — | — | — | 1 |
Indications Phases 1
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Indications Without Phase
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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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PubMed Central
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Safety
Black-box Warning
Black-box warning for: Ampicillin
Adverse Events
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6,645 adverse events reported
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