FDA label
What is cephalexin used for?
The FDA-approved uses of cephalexin, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for cephalexin (capsule) lists 6 uses: Respiratory Tract Infections; Otitis Media; Skin and Skin Structure Infections; Bone Infections; and 2 more.
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Cephalexin, capsule
Indications and Usage, quoted from the label by Aurobindo Pharma Limited (ANDA065253). Cross-references to other label sections are left out.
Respiratory Tract Infections
Cephalexin capsules are indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes.
Otitis Media
Cephalexin capsules are indicated for the treatment of otitis media caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis.
Skin and Skin Structure Infections
Cephalexin capsules are indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus and Streptococcus pyogenes.
Bone Infections
Cephalexin capsules are indicated for the treatment of bone infections caused by susceptible isolates of Staphylococcus aureus and Proteus mirabilis.
Genitourinary Tract Infections
Cephalexin capsules are indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae.
Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules and other antibacterial drugs, cephalexin capsules should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information is available, this information should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Source: DailyMed label, set id f957ea27-2906-40c7-ac03-eb2f742473a0, version 3, effective September 15, 2026. NDC 59651-728, one of 142 listings for this product.
Cephalexin, for suspension
Indications and Usage, quoted from the label by Ascend Laboratories, LLC (ANDA210221). Cross-references to other label sections are left out.
Respiratory Tract Infections
Cephalexin for oral suspension is indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes in adults and pediatric patients aged one year and older.
Otitis Media
Cephalexin for oral suspension is indicated for the treatment of otitis media caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis in adults and pediatric patients aged one year and older.
Skin and Skin Structure Infections
Cephalexin for oral suspension is indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus and Streptococcus pyogenes in adults and pediatric patients aged one year and older.
Bone Infections
Cephalexin for oral suspension is indicated for the treatment of bone infections caused by susceptible isolates of Staphylococcus aureus and Proteus mirabilis in adults and pediatric patients aged one year and older.
Genitourinary Tract Infections
Cephalexin for oral suspension is indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae in adults and pediatric patients aged one year and older.
Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin for oral suspension and other antibacterial drugs, cephalexin for oral suspension should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information is available, this information should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Source: DailyMed label, set id bb28751c-bd1b-4e7f-8271-a14c1b4314e3, version 9, effective October 12, 2026. NDC 67877-544, one of 28 listings for this product.
Questions
What is cephalexin used for?
The FDA label for cephalexin (capsule) lists 6 uses: Respiratory Tract Infections; Otitis Media; Skin and Skin Structure Infections; Bone Infections; and 2 more.
What drug class is cephalexin?
FDA lists cephalexin in the Cephalosporin Antibacterial established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.