FDA label

What is vancomycin used for?

The FDA-approved uses of vancomycin, 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 vancomycin hydrochloride (injection, powder, lyophilized, for solution) lists 6 uses: Septicemia; Infective Endocarditis; Skin and Skin Structure Infections; Bone Infections; and 2 more.

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Vancomycin Hydrochloride, injection, powder, lyophilized, for solution

Indications and Usage, quoted from the label by Sagent Pharmaceuticals (ANDA218140). Cross-references to other label sections are left out.

Septicemia

Vancomycin Hydrochloride for Injection is indicated in adults and pediatric patients (neonates and older) for the treatment of septicemia due to:

  • Susceptible isolates of methicillin-resistant Staphylococcus aureus (MRSA) and coagulase negative staphylococci.
  • Methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or who have failed to respond to other drugs, including penicillins or cephalosporins.

Infective Endocarditis

Vancomycin Hydrochloride for Injection is indicated in adults and pediatric patients (neonates and older) for the treatment of infective endocarditis due to:

  • Susceptible isolates of MRSA.
  • Viridans group streptococci Streptococcus gallolyticus (previously known as Streptococcus bovis), Enterococcus species and Corynebacterium species. For enterococcal endocarditis, use Vancomycin Hydrochloride for Injection in combination with an aminoglycoside.
  • Methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or who have failed to respond to other drugs, including penicillins or cephalosporins.

Vancomycin Hydrochloride for Injection is indicated in adults and pediatric patients (neonates and older) for the treatment of early-onset prosthetic valve endocarditis caused by Staphylococcus epidermidis in combination with rifampin and an aminoglycoside.

Skin and Skin Structure Infections

Vancomycin Hydrochloride for Injection is indicated in adults and pediatric patients (neonates and older) for the treatment of skin and skin structure infections due to:

  • Susceptible isolates of MRSA and coagulase negative staphylococci.
  • Methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or who have failed to respond to other drugs, including penicillins or cephalosporins.

Bone Infections

Vancomycin Hydrochloride for Injection is indicated in adults and pediatric patients (neonates and older) for the treatment of bone infections due to:

  • Susceptible isolates of MRSA and coagulase negative staphylococci.
  • Methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or who have failed to respond to other drugs, including penicillins or cephalosporins.

Lower Respiratory Tract Infections

Vancomycin Hydrochloride for Injection is indicated in adults and pediatric patients (neonates and older) for the treatment of lower respiratory tract infections due to:

  • Susceptible isolates of MRSA
  • Methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or who have failed to respond to other drugs, including penicillins or cephalosporins.

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection and other antibacterial drugs, Vancomycin Hydrochloride for Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they 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 f623889c-a47a-4b3a-b3a9-e04051f5c2df, version 1, effective May 28, 2025. NDC 25021-147, one of 87 listings for this product.

Vancomycin Hydrochloride, capsule

Indications and Usage, quoted from the label by Cameron Pharmaceuticals (ANDA210729). Cross-references to other label sections are left out.

Vancomycin Hydrochloride Capsules are indicated for the treatment of C. difficile-associated diarrhea.

Limitations of Use

  • Parenteral administration of vancomycin is not effective for the above infections; therefore, Vancomycin Hydrochloride Capsules must be given orally for these infections.
  • Orally administered Vancomycin Hydrochloride Capsules is not effective for other types of infections.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride Capsules and other antibacterial drugs, Vancomycin Hydrochloride Capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they 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 bc737938-ae36-460b-a2a8-609f3fe59156, version 6, effective August 17, 2026. NDC 42494-450, one of 13 listings for this product.

Vancomycin Hydrochloride, powder, for solution

Indications and Usage, quoted from the label by ANI Pharmaceuticals, Inc. (ANDA061667). Cross-references to other label sections are left out.

Vancomycin Hydrochloride for Oral Solution is administered orally for treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic-associated pseudomembranous colitis caused by C. difficile. Parenteral administration of vancomycin is not effective for the above indications; therefore,

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Oral Solution and other antibacterial drugs, Vancomycin Hydrochloride for Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they 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 27d06545-1af0-4dcd-926d-58d4a9492ec3, version 3, effective March 2, 2026. NDC 62559-830, one of 7 listings for this product.

Questions

What is vancomycin used for?

The FDA label for vancomycin hydrochloride (injection, powder, lyophilized, for solution) lists 6 uses: Septicemia; Infective Endocarditis; Skin and Skin Structure Infections; Bone Infections; and 2 more.

What drug class is vancomycin?

FDA lists vancomycin in the Glycopeptide 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.

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