MedPath

Ampicillin

Generic Name
Ampicillin
Brand Names
Unasyn
Drug Type
Small Molecule
Chemical Formula
C16H19N3O4S
CAS Number
69-53-4
Unique Ingredient Identifier
7C782967RD

Overview

Ampicillin is a semi-synthetic derivative of penicillin that functions as an orally active broad-spectrum antibiotic.

Indication

For treatment of infection (Respiratory, GI, UTI and meningitis) due to E. coli, P. mirabilis, enterococci, Shigella, S. typhosa and other Salmonella, nonpenicillinase-producing N. gononhoeae, H. influenzae, staphylococci, streptococci including streptoc

Associated Conditions

  • Bacterial Infections
  • Endocarditis
  • Gastrointestinal Tract Infections
  • Genitourinary tract infection
  • Infection
  • Infection caused by eikenella corrodens
  • Listeria infection
  • Meningitis, Bacterial
  • Pertussis
  • Respiratory Tract Infections (RTI)
  • Salmonella
  • Septicemia
  • Shigella
  • Subcutaneous bacterial infection
  • Urinary Tract Infection
  • Bacterial skin infections
  • Disease caused by Salmonella typhi
  • Perinatal group B streptococcus
  • Susceptible Bacterial Infections

Research Report

Published: Aug 21, 2025

A Comprehensive Monograph on Ampicillin (DB00415): From Molecular Structure to Clinical Practice

Executive Summary

Ampicillin is a seminal semi-synthetic, broad-spectrum β-lactam antibiotic belonging to the aminopenicillin class. Developed in 1961, it represented a significant advancement over natural penicillins by extending antimicrobial coverage to include various Gram-negative pathogens. Its bactericidal action is achieved through the irreversible inhibition of bacterial cell wall synthesis via binding to penicillin-binding proteins (PBPs). Despite its historical importance, its clinical utility has been significantly curtailed by the global rise of bacterial resistance, primarily mediated by β-lactamase enzymes. Consequently, its use is now more targeted, often guided by susceptibility testing or used in combination with β-lactamase inhibitors like sulbactam. This monograph provides an exhaustive analysis of Ampicillin's chemical properties, pharmacology, microbiology, clinical applications, and safety profile, contextualizing its enduring, albeit diminished, role in modern antimicrobial therapy.

Section 1: Chemical Profile and Formulations

The foundational identity and physical characteristics of Ampicillin are critical to understanding its biological function, pharmaceutical development, and clinical handling. Its unique chemical structure is directly responsible for its expanded spectrum of activity compared to earlier penicillins, while its physicochemical properties dictate the specific protocols required for its safe and effective administration.

1.1 Identification and Nomenclature

A precise and standardized identification is essential for any pharmaceutical agent. Ampicillin is cataloged across numerous chemical and pharmacological databases under specific identifiers that define its structure and therapeutic class.

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2024/07/10
Phase 4
Recruiting
2024/06/07
Phase 4
Completed
2024/05/02
Phase 4
Recruiting
2024/04/16
Phase 4
Recruiting
Uji Takeda Hospital
2023/08/04
Phase 3
Not yet recruiting
2022/07/22
Not Applicable
Recruiting
2021/09/21
Phase 2
UNKNOWN
2021/08/25
Phase 2
Recruiting
2019/12/17
Not Applicable
Completed
2019/08/01
Phase 3
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Fresenius Kabi USA, LLC
65219-018
INTRAMUSCULAR, INTRAVENOUS
1 g in 1 1
1/24/2020
NorthStar Rx, LLC
72603-220
INTRAVENOUS, INTRAMUSCULAR
1 g in 1 1
2/28/2024
NorthStar Rx, LLC
72603-454
INTRAMUSCULAR, INTRAVENOUS
2 g in 1 1
2/22/2024
Medical Purchasing Solutions, LLC
71872-7240
INTRAMUSCULAR, INTRAVENOUS
2 g in 1 1
5/8/2023
Medical Purchasing Solutions, LLC
71872-7286
INTRAVENOUS
1 g in 1 1
5/2/2023
Sandoz Inc
0781-3402
INTRAVENOUS, INTRAMUSCULAR
250 mg in 1 1
10/20/2017
Methapharm, Inc.
67850-131
INTRAVENOUS, INTRAMUSCULAR
2 g in 1 1
1/21/2022
Eugia US LLC
55150-114
INTRAVENOUS
2 g in 1 1
8/14/2025
WG Critical Care, LLC
44567-211
INTRAVENOUS, INTRAMUSCULAR
2 g in 20 mL
2/23/2023
Physicians Total Care, Inc.
54868-3113
ORAL
500 mg in 1 1
6/5/2012

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
STANDACILLIN FOR INJECTION 0.5 g/vial
SIN00680P
INJECTION, POWDER, FOR SOLUTION
500 mg/vial
5/3/1988
UNASYN 750 FOR INJECTION
SIN01950P
INJECTION, POWDER, FOR SOLUTION
500 mg/vial
6/23/1988
UNASYN 3000 FOR INJECTION
SIN01949P
INJECTION, POWDER, FOR SOLUTION
2 g/vial
6/23/1988
UNASYN 1500 FOR INJECTION
SIN01948P
INJECTION, POWDER, FOR SOLUTION
1 g/vial
6/23/1988

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

TGA Drug Approvals

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
PRO AMPI 500 CAP 500MG
PRO DOC LIMITEE
00628360
Capsule - Oral
500 MG / CAP
12/31/1985
APO AMPI CAPSULES 250MG
00603279
Capsule - Oral
250 MG
12/31/1984
NU-AMPI SUSPENSION 250MG/5ML
nu-pharm inc
00717649
Suspension - Oral
250 MG / 5 ML
12/31/1990
NOVO-AMPICILLIN SUS 125MG/5ML
novopharm limited
00021121
Powder For Solution - Oral
125 MG / 5 ML
12/31/1971
NOVO-AMPICILLIN SUS 250MG/5ML
novopharm limited
00021148
Powder For Solution - Oral
250 MG / 5 ML
12/31/1971
PRO BIOSAN KIT
icn canada ltd.
00284009
Tablet ,  Capsule - Oral
500 MG / PCK
12/31/1979
NOVO-AMPICILLIN PWS 500MG/5ML
novopharm limited
00231207
Powder For Solution - Oral
500 MG / 5 ML
12/31/1972
NU-AMPI CAPSULES 250MG
nu-pharm inc
00717657
Capsule - Oral
250 MG
12/31/1990
PENBRITIN CAP 250MG
ayerst laboratories
00002003
Capsule - Oral
250 MG / CAP
12/31/1962
NU-AMPI CAPSULES 500MG
nu-pharm inc
00717673
Capsule - Oral
500 MG
12/31/1990

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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