MedPath

Amoxicillin

Generic Name
Amoxicillin
Brand Names
Amoxil, Augmentin, Clavulin, Moxatag, Omeclamox, Prevpac, Talicia, Voquezna 14 Day Dualpak 20;500, Voquezna 14 Day Triplepak 20;500;500
Drug Type
Small Molecule
Chemical Formula
C16H19N3O5S
CAS Number
26787-78-0
Unique Ingredient Identifier
9EM05410Q9

Overview

Amoxicillin, or BRL-2333, is a penicillin G derivative first described in the literature in 1972. Amoxicillin has similar activity to penicillin and ampicillin, but leads to higher serum concentrations than ampicillin. Amoxicillin was granted FDA approval on 18 January 1974.

Background

Amoxicillin, or BRL-2333, is a penicillin G derivative first described in the literature in 1972. Amoxicillin has similar activity to penicillin and ampicillin, but leads to higher serum concentrations than ampicillin. Amoxicillin was granted FDA approval on 18 January 1974.

Indication

Amoxicillin alone is indicated to treat susceptible bacterial infections of the ear, nose, throat, genitourinary tract, skin, skin structure, and lower respiratory tract. Amoxicillin is given with calvulanic acid to treat acute bacterial sinusitis, community acquired pneumonia, lower respiratory tract infections, acute bacterial otitis media, skin and skin structure infections, and urinary tract infections. Amoxicillin is given with omeprazole in the treatment of Helicobacter pylori (H. pylori) infection. Amoxicillin is used in combination with vonoprazan and clarithromycin as co-packaged triple therapy or in combination with vonoprazan as co-packaged dual therapy to treat H. pylori infection in adults.

Associated Conditions

  • Acute Bacterial Sinusitis (ABS)
  • Acute Otitis Media (AOM)
  • Bacterial Infections
  • Community Acquired Pneumonia (CAP)
  • Duodenal ulcer caused by helicobacter pylori
  • Genitourinary tract infection
  • Helicobacter Pylori Infection
  • Lower Respiratory Tract Infection (LRTI)
  • Peptic Ulcer With H. Pylori Infection
  • Sinusitis
  • Skin and Subcutaneous Tissue Bacterial Infections
  • Urinary Tract Infection
  • Acute, uncomplicated Gonorrhea
  • Ear, nose, and throat infections

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/05/09
Phase 3
Not yet recruiting
2025/04/10
Phase 2
Not yet recruiting
2025/03/28
Early Phase 1
Not yet recruiting
2025/03/14
Phase 3
Active, not recruiting
Hospital de Niños R. Gutierrez de Buenos Aires
2025/03/11
Not Applicable
Not yet recruiting
2025/02/28
Not Applicable
Not yet recruiting
Key Laboratory for Gastrointestinal Diseases of Gansu Province
2025/02/12
Phase 1
Active, not recruiting
2025/02/06
Phase 3
ENROLLING_BY_INVITATION
Chang Gung Memorial Hospital
2025/01/16
Early Phase 1
Not yet recruiting
2025/01/13
Phase 3
Recruiting
Bart Koes

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
A-S Medication Solutions
50090-6355
ORAL
400 mg in 5 mL
12/12/2022
Proficient Rx LP
63187-044
ORAL
500 mg in 1 1
11/1/2018
Bryant Ranch Prepack
63629-7798
ORAL
500 mg in 1 1
12/14/2015
NuCare Pharmaceuticals,Inc.
68071-4696
ORAL
125 mg in 5 mL
2/17/2021
Preferred Pharmaceuticals Inc.
68788-7958
ORAL
875 mg in 1 1
2/8/2024
A-S Medication Solutions
50090-1814
ORAL
250 mg in 5 mL
6/7/2023
Direct_Rx
61919-716
ORAL
250 mg in 5 mL
1/12/2023
NuCare Pharmaceuticals,Inc.
68071-2323
ORAL
250 mg in 1 1
1/6/2021
Pharmasource Meds, LLC
82982-069
ORAL
875 mg in 1 1
5/26/2023
Aidarex Pharmaceuticals LLC
33261-726
ORAL
250 mg in 5 mL
3/28/2014

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
BETAMOX GRANULES 125 mg/5 ml
SIN04143P
GRANULE, FOR SUSPENSION
125 mg/5 ml
4/20/1990
MOXICLAV DRY POWDER FOR ORAL SUSPENSION 156.25 mg/5 ml
SIN10690P
POWDER, FOR SUSPENSION
125 mg/5 ml
1/20/1999
CLAMOVID 625 TABLET 625 mg
SIN12026P
TABLET, FILM COATED
500 mg
7/17/2002
AMOXICAP 500 CAPSULE 500 mg
SIN09681P
CAPSULE
500 mg
3/19/1998
STRIMOX-250 CAPSULE 250 mg
SIN11417P
CAPSULE
250 mg
10/28/2000
PULMOXYL DRY SYRUP 125 mg/5ml
SIN11300P
SYRUP
125 mg/5ml
4/5/2000
AMOXIGRAN GRANULES 125 mg/5 ml
SIN07648P
GRANULE, FOR SUSPENSION
125 mg/5 ml
2/16/1994
PULMOXYL - 500 CAPSULE 500 mg (Maroon/yellow)
SIN11190P
CAPSULE
500.00 mg
9/24/1999
AMOXAPEN 250 CAPSULE 250 mg
SIN01607P
CAPSULE
250 mg
6/1/1988
AMOXAPEN 500 CAPSULE 500 mg
SIN01943P
CAPSULE
500 mg
6/23/1988

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Amoxicillin Orally Disintegrating Tablets
国药准字H20080277
化学药品
片剂
1/13/2023
Amoxicillin Sodium for Injection
国药准字H20253300
化学药品
注射剂
1/24/2025
Amoxicillin Sodium for Injection
国药准字H20253299
化学药品
注射剂
1/24/2025
Amoxicillin Sodium for Injection
国药准字H20253301
化学药品
注射剂
1/24/2025
Amoxicillin Sodium for Injection
国药准字H14020690
化学药品
注射剂
7/28/2020
Amoxicillin Sodium for Injection
国药准字H20023124
化学药品
注射剂(无菌分装粉针剂)
4/13/2020
Amoxicillin Sodium for Injection
国药准字H20034100
化学药品
注射剂(无菌分装粉针剂)
6/22/2020
Amoxicillin Sodium for Injection
国药准字H20020449
化学药品
注射剂
2/7/2020
Amoxicillin Sodium for Injection
国药准字H43022048
化学药品
注射剂
8/30/2023
Amoxicillin Sodium for Injection
国药准字H20044607
化学药品
注射剂
5/21/2020

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.
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