FDA label

What is cefazolin used for?

The FDA-approved uses of cefazolin, 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 cefazolin sodium (injection, powder, lyophilized, for solution) lists 9 uses: Respiratory Tract Infections; Urinary Tract Infections; Skin and Skin Structure Infections; Biliary Tract Infections; and 5 more.

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Cefazolin, injection, powder, for solution

Indications and Usage, quoted from the label by WG Critical Care, LLC (ANDA065303). Cross-references to other label sections are left out.

Cefazolin for Injection, USP is indicated for the treatment of the following serious infections when due to susceptible organisms.

Respiratory Tract Infections: Due to S. pneumoniae, Klebsiella species, H. influenzae, S. aureus (penicillin-sensitive and penicillin-resistant), and group A beta-hemolytic streptococci.

Injectable benzathine penicillin is considered the drug of choice in treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever.

Cefazolin for Injection, USP is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of

Urinary Tract Infections: Due to E. coli, P. mirabilis, Klebsiella species, and some strains of enterobacter and enterococci.

Skin and Skin Structure Infections: Due to S. aureus (penicillin‑sensitive and penicillin-resistant), group A beta‑hemolytic streptococci, and other strains of streptococci.

Biliary Tract Infections: Due to E. coli, various strains of streptococci, P. mirabilis, Klebsiella species, and S. aureus.

Bone and Joint Infections: Due to S. aureus.

Genital Infections: (i.e., prostatitis, epididymitis) due to E. coli, P. mirabilis, Klebsiella species, and some strains of enterococci.

Septicemia: Due to S. pneumoniae, S. aureus (penicillin‑sensitive and penicillin‑resistant), P. mirabilis, E. coli, and Klebsiella species.

Endocarditis: Due to S. aureus (penicillin‑sensitive and penicillin‑resistant) and group A beta‑hemolytic streptococci.

Perioperative Prophylaxis: The prophylactic administration of Cefazolin for Injection preoperatively, intraoperatively, and postoperatively may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures which are classified as contaminated or potentially contaminated (e.g., vaginal hysterectomy, and cholecystectomy in high‑risk patients such as those older than 70 years, with acute cholecystitis, obstructive jaundice, or common duct bile stones).

The perioperative use of Cefazolin for Injection may also be effective in surgical patients in whom infection at the operative site would present a serious risk (e.g., during open‑heart surgery and prosthetic arthroplasty).

The prophylactic administration of Cefazolin for Injection should usually be discontinued within a 24‑hour period after the surgical procedure. In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of Cefazolin for Injection may be continued for 3 to 5 days following the completion of surgery.

If there are signs of infection, specimens for cultures should be obtained for the identification of the causative organism so that appropriate therapy may be instituted.

(See DOSAGE AND ADMINISTRATION.)

To reduce the development of drug‑resistant bacteria and maintain the effectiveness of Cefazolin for Injection and other antibacterial drugs, Cefazolin 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 00dd6da7-50a8-44c9-b2dc-7948973df392, version 6, effective January 7, 2026. NDC 44567-120, one of 31 listings for this product.

Cefazolin Sodium, powder, for solution

Indications and Usage, quoted from the label by Fresenius Kabi USA, LLC (ANDA065303). Cross-references to other label sections are left out.

Cefazolin for Injection, USP is indicated for the treatment of the following serious infections when due to susceptible organisms. Respiratory Tract Infections: Due to S. pneumoniae, Klebsiella species, H. influenzae, S. aureus (penicillin-sensitive and penicillin-resistant), and group A beta-hemolytic streptococci. Injectable benzathine penicillin is considered the drug of choice in treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever.

Source: DailyMed label, set id c47c8d14-1eef-40f9-9d11-f0c300b1d4be, version 8, effective September 27, 2023. NDC 63323-236, one of 3 listings for this product.

Cefazolin Sodium, injection, powder, lyophilized, for solution

Indications and Usage, quoted from the label by Samson Medical Technologies, L.L.C. (ANDA065141). Cross-references to other label sections are left out.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefazolin and other antibacterial drugs, cefazolin 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.

Cefazolin for Injection is indicated for the treatment of the following infections when caused by susceptible bacteria.

Respiratory Tract Infections

Respiratory tract infections due to Streptococcus pneumoniae, Staphylococcus aureus and Streptococcus pyogenes.

Injectable benzathine penicillin is considered the drug of choice in treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever.

Cefazolin is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of cefazolin in the subsequent prevention of rheumatic fever are not available.

Urinary Tract Infections

Urinary tract infections due to Escherichia coli and Proteus mirabilis.

Skin and Skin Structure Infections

Skin and skin structure infections due to S. aureus, S. pyogenes, and Streptococcus agalactiae.

Biliary Tract Infections

Biliary infections due to E. coli, various isolates of streptococci, P. mirabilis, and S. aureus.

Bone and Joint Infections

Bone and joint infections due to S. aureus.

Genital Infections

Genital infections due to E. coli and P. mirabilis.

Septicemia

Septicemia due to S. pneumoniae, S. aureus, P. mirabilis, and E. coli.

Endocarditis

Endocarditis due to S. aureus and S. pyogenes.

Perioperative Prophylaxis

The prophylactic administration of cefazolin preoperatively, intraoperatively, and postoperatively may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures which are classified as contaminated or potentially contaminated (e.g., vaginal hysterectomy, and cholecystectomy in high-risk patients such as those older than 70 years, with acute cholecystitis, obstructive jaundice, or common duct bile stones).

The perioperative use of cefazolin may also be effective in surgical patients in whom infection at the operative site would present a serious risk (e.g., during open-heart surgery and prosthetic arthroplasty).

If there are signs of infection, specimens for cultures should be obtained for the identification of the causative organism so that appropriate therapy may be instituted.

Source: DailyMed label, set id cf13db9c-d8a1-489f-9aa0-fc70839d4bbc, version 10, effective January 8, 2025. NDC 66288-1100, one of 2 listings for this product.

Questions

What is cefazolin used for?

The FDA label for cefazolin sodium (injection, powder, lyophilized, for solution) lists 9 uses: Respiratory Tract Infections; Urinary Tract Infections; Skin and Skin Structure Infections; Biliary Tract Infections; and 5 more.

What drug class is cefazolin?

FDA lists cefazolin 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.

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