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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Variants

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FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

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Commercial

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	2024-11-04
ampicillin ampicillin sodium	ANDA	2023-11-10
ampicillin and sulbactam	ANDA	2024-10-17
ampicillin sodium	ANDA	2023-05-03
ampicillin sodium and sulbactam sodium	ANDA	2024-10-28
unasyn	New Drug Application	2024-10-15

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

200 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	—	1	1	3	9	9	22
Pneumonia	D011014	EFO_0003106	—	—	3	8	6	6	20
Schizophrenia	D012559	EFO_0000692	F20	5	3	1	1	8	17
Communicable diseases	D003141	—	—	—	—	1	6	6	13
Sepsis	D018805	HP_0100806	A41.9	—	2	3	2	4	11
Syphilis	D013587	EFO_0007504	A53.9	1	2	4	2	1	9
Premature birth	D047928	EFO_0003917	O60	—	—	1	3	4	8
Premature rupture fetal membranes	D005322	HP_0001788	O42	—	1	3	2	3	8
Rupture	D012421	—	—	—	1	3	2	3	8
Hiv infections	D015658	EFO_0000764	B20	—	2	4	1	2	7

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Chorioamnionitis	D002821	—	O41.12	—	2	3	—	1	4
Bacterial pneumonia	D018410	EFO_1001272	J15.9	—	1	2	—	—	2
Inflammation	D007249	MP_0001845	—	—	—	1	—	1	2
Malnutrition	D044342	EFO_0008572	E40-E46	—	1	2	—	—	2
Severe acute malnutrition	D000067011	—	—	—	1	2	—	—	2
Neurosyphilis	D009494	EFO_0007339	A50.4	—	—	1	—	1	2
Endometritis	D004716	EFO_1001312	—	—	1	1	—	1	2
Abscess	D000038	EFO_0003030	—	—	—	1	—	1	2
Lung abscess	D008169	EFO_1001362	J85.2	—	—	1	—	1	2
Uterine cervical neoplasms	D002583	HP_0030159	—	1	—	1	—	—	2

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Lymphoma	D008223	—	C85.9	3	2	—	—	—	4
Psoriasis	D011565	EFO_0000676	L40	—	2	—	—	2	4
Heart diseases	D006331	EFO_0003777	I51.9	—	2	—	—	2	4
Rheumatic heart disease	D012214	EFO_1001161	I09.9	—	2	—	—	2	4
Carcinoma	D002277	—	C80.0	2	1	—	—	—	3
Rheumatic diseases	D012216	—	M79.0	—	2	—	—	1	3
Urinary bladder neoplasms	D001749	—	C67	2	1	—	—	—	3
Non-muscle invasive bladder neoplasms	D000093284	—	—	2	1	—	—	—	3
Non-hodgkin lymphoma	D008228	—	C85.9	2	1	—	—	—	2
Large b-cell lymphoma diffuse	D016403	—	C83.3	2	1	—	—	—	2

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Healthy volunteers/patients	—	—	—	3	—	—	—	4	7
Head and neck neoplasms	D006258	—	—	2	—	—	—	—	2
Squamous cell carcinoma	D002294	—	—	2	—	—	—	—	2
Small cell carcinoma	D018288	—	—	2	—	—	—	—	2
Squamous cell carcinoma of head and neck	D000077195	—	—	2	—	—	—	—	2
Esophageal neoplasms	D004938	—	C15	1	—	—	—	1	2
Streptococcal infections	D013290	EFO_1001476	—	1	—	—	—	1	2
Pharyngitis	D010612	—	R07.0	1	—	—	—	1	2
Osteomyelitis	D010019	EFO_0003102	M86	1	—	—	—	—	1
Mouth neoplasms	D009062	EFO_0003868	C06.9	1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hypoxia	D000860	HP_0012418	R09.02	—	—	—	—	2	2
Glaucoma	D005901	EFO_0000516	H40	—	—	—	—	2	2
Critical illness	D016638	—	—	—	—	—	—	1	1
Salmonella infections	D012480	EFO_1001418	A02.9	—	—	—	—	1	1
Hiv seropositivity	D006679	—	—	—	—	—	—	1	1
Colorectal neoplasms	D015179	—	—	—	—	—	—	1	1
Rectal neoplasms	D012004	—	—	—	—	—	—	1	1
Retained placenta	D018457	—	O72.0	—	—	—	—	1	1
Hepatitis c	D006526	—	B19.2	—	—	—	—	1	1
Chronic hepatitis c	D019698	EFO_0004220	B18.2	—	—	—	—	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)

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 208,060 documents

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Safety

Black-box Warning

No Black-box warning

Adverse Events

Top Adverse Reactions

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5,787 adverse events reported

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