Ampicillin - PharmaKB

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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EMA approval date

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Therapeutic Areas

Therapeutic Area	MeSH
infections	D007239
digestive system diseases	D004066
respiratory tract diseases	D012140
nervous system diseases	D009422
urogenital diseases	D000091642
cardiovascular diseases	D002318
skin and connective tissue diseases	D017437
signs and symptoms pathological conditions	D013568
wounds and injuries	D014947

Trade Name

FDA

EMA

Ampicillin (discontinued: Ampicillin, Omnipen-n, Penbritin-s, Polycillin-n, Totacillin-n)

Combinations

Ampicillin 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

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Ampicillin

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

Sulbactam sodium

Tradename	Company	Number	Date	Products
UNASYN	Pfizer	N-050608 RX	1986-12-31	3 products, RLD, RS

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Ampicillin

Ampicillin trihydrate

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	2025-09-03
ampicillin ampicillin sodium	ANDA	2023-11-10
ampicillin and sulbactam	ANDA	2025-08-12
ampicillin sodium	ANDA	2025-09-08
ampicillin sodium and sulbactam sodium	ANDA	2025-09-08
unasyn	New Drug Application	2025-05-14

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
respiratory tract infections	—	D012141	J06.9
urinary tract infections	EFO_0003103	D014552	N39.0
pneumococcal infections	EFO_0000772	D011008	J13
infectious pregnancy complications	—	D011251	—
bacterial infections	—	D001424	A49
gonorrhea	DOID_7551	D006069	A54
bacterial skin diseases	—	D017192	—
escherichia coli infections	EFO_1001318	D004927	B96.20
soft tissue infections	—	D018461	—
bacillary dysentery	—	D004405	A03

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Agency Specific

FDA

EMA

No data

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

HCPCS

Code	Description
J0290	Injection, ampicillin sodium, 500 mg
J0295	Injection, ampicillin sodium/sulbactam sodium, per 1.5 gm

Clinical

Clinical Trials

925 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	—	12	20	51	124	73	266
Communicable diseases	D003141	—	—	1	6	24	44	32	104
Helicobacter infections	D016481	EFO_1000961	—	5	8	19	38	24	90
Pneumonia	D011014	EFO_0003106	J18	5	12	25	24	20	77
Healthy volunteers/patients	—	—	—	18	—	1	3	11	33
Sepsis	D018805	EFO_0001420	A41.9	2	4	7	9	13	33
Gastritis	D005756	EFO_0000217	K29.7	3	2	7	17	4	32
Periodontitis	D010518	EFO_0000649	K05.3	1	5	6	10	7	26
Sinusitis	D012852	EFO_0007486	J32	—	1	5	11	6	23
Bacterial infections	D001424	—	A49	4	2	—	11	6	23

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Lymphoma	D008223	—	C85.9	3	7	5	—	4	16
Tuberculosis	D014376	EFO_0000774	A15-A19	1	6	2	—	1	9
Hiv infections	D015658	EFO_0000764	B20	—	2	4	—	3	7
Abscess	D000038	EFO_0003030	—	—	1	4	—	2	7
Leukemia	D007938	—	C95	1	2	3	—	2	6
Hematologic neoplasms	D019337	—	—	1	2	2	—	2	6
Multiple myeloma	D009101	—	C90.0	—	2	3	—	3	6
Plasma cell neoplasms	D054219	—	—	—	2	3	—	2	5
Non-hodgkin lymphoma	D008228	—	C85.9	2	2	2	—	1	5
Rheumatic heart disease	D012214	EFO_1001161	I09.9	—	2	1	—	2	5

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
B-cell lymphoma	D016393	—	—	2	2	—	—	1	4
Obesity	D009765	EFO_0001073	E66.9	1	1	—	—	3	4
Psoriasis	D011565	EFO_0000676	L40	—	2	—	—	2	4
Pulmonary tuberculosis	D014397	EFO_1000049	A15	—	4	—	—	—	4
Insulin resistance	D007333	EFO_0002614	E88.819	—	1	—	—	2	3
Carcinoma	D002277	—	C80.0	2	1	—	—	—	3
Large b-cell lymphoma diffuse	D016403	—	C83.3	2	2	—	—	—	3
B-cell lymphoma marginal zone	D018442	—	C88.4	—	1	—	—	2	3
Congenital syphilis	D013590	EFO_0007219	A50	—	2	—	—	1	3
Non-muscle invasive bladder neoplasms	D000093284	—	—	2	1	—	—	—	3

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Gastrointestinal diseases	D005767	—	—	1	—	—	—	2	3
Digestive system diseases	D004066	EFO_0000405	K92.9	1	—	—	—	2	3
Squamous cell carcinoma	D002294	—	—	2	—	—	—	—	2
Chemical and drug induced liver injury	D056486	EFO_0004228	—	1	—	—	—	1	2
Impacted tooth	D014095	—	K01.1	1	—	—	—	1	2
Small cell carcinoma	D018288	—	—	2	—	—	—	—	2
Squamous cell carcinoma of head and neck	D000077195	—	—	2	—	—	—	—	2
Anxiety	D001007	EFO_0005230	F41.1	1	—	—	—	1	2
Drug interactions	D004347	—	—	2	—	—	—	—	2
Esophageal neoplasms	D004938	—	C15	1	—	—	—	1	2

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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
Hypoxia	D000860	—	R09.02	—	—	—	—	2	2
Hematopoietic stem cell transplantation	D018380	—	—	—	—	—	—	2	2
Seizures	D012640	—	G40.4	—	—	—	—	2	2
Gram-positive bacterial infections	D016908	—	—	—	—	—	—	2	2
Protein-energy malnutrition	D011502	EFO_0009563	E41	—	—	—	—	2	2
Glaucoma	D005901	EFO_0000516	H40	—	—	—	—	2	2
Microbiota	D064307	—	—	—	—	—	—	2	2
Thyroid nodule	D016606	EFO_1001436	—	—	—	—	—	2	2
Periapical periodontitis	D010485	EFO_1001391	K04.5	—	—	—	—	2	2

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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)

Target

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Variants

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Financial

Revenue by drug

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Estimated US medical usage

Ampicillin

Total medical expenditures per year (USD, in millions)

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Ampicillin

Sulbactam

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Trends

PubMed Central

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Additional graphs summarizing 226,166 documents

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Safety

Black-box Warning

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Adverse Events

Top Adverse Reactions

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6,645 adverse events reported

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