MedPath

Ceftibuten

Generic Name
Ceftibuten
Brand Names
Cedax
Drug Type
Small Molecule
Chemical Formula
C15H14N4O6S2
CAS Number
97519-39-6
Unique Ingredient Identifier
IW71N46B4Y

Overview

Ceftibuten is a third-generation cephalosporin antibiotic that is orally-administered. It is typically used to treat acute bacterial exacerbations of chronic bronchitis (ABECB), acute bacterial otitis media, pharyngitis, and tonsilitis.

Background

Ceftibuten is a third-generation cephalosporin antibiotic that is orally-administered. It is typically used to treat acute bacterial exacerbations of chronic bronchitis (ABECB), acute bacterial otitis media, pharyngitis, and tonsilitis.

Indication

Indicated for the treatment of acute bacterial exacerbations of chronic bronchitis (ABECB), acute bacterial otitis media, pharyngitis, and tonsilitis.

Associated Conditions

  • Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB)
  • Acute Otitis Media (AOM)
  • Acute Sinusitis
  • Acute Tracheobronchitis
  • Bacterial Infections
  • Bacterial Pneumonia
  • Lower Respiratory Tract Infection (LRTI)
  • Lower Respiratory Tract Infection (LRTI) caused by susceptible bacteria
  • Pharyngitis
  • Skin and Soft Tissue Infections (SSTIs)
  • Streptococcal Pharyngitis
  • Superinfection bacterial
  • Tonsillitis
  • Tonsillitis streptococcal
  • Upper Respiratory Tract Infection
  • Upper Respiratory Tract Infection caused by susceptible bacteria
  • Urinary Tract Infection caused by susceptible bacteria
  • Bacterial otitis media
  • Uncomplicated Lower Respiratory Tract Infection (LRTI)
  • Uncomplicated Upper Respiratory Tract Infection
  • Uncomplicated Urethritis gonococcal

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Sciele Pharma, Inc.
59630-820
ORAL
400 mg in 1 1
1/12/2010
Sciele Pharma, Inc.
59630-821
ORAL
18 mg in 1 mL
1/12/2010

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
No HSA approvals found for this drug.

NMPA Drug Approvals

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

PPB Drug Approvals

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

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.
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