TheraRadar
Data updated: Jun 28, 2026

CEFAZOLIN SODIUM · QILU ANTIBIOTICS

Infectious Disease Approved 1973-10-04

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

NDA
Small Molecule
24
Indications
--
Phase 3 Trials
52
Years on Market

CEFAZOLIN SODIUM Approval History

1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
400 FDA actions from 1988 to 2026 · 2 indication expansions
Feb 2026 SUPPL
Efficacy
Dec 2025 SUPPL
Mfg · Manufacturing (CMC)
Aug 2025 SUPPL
Label · Labeling

What CEFAZOLIN SODIUM Treats

8 indications

CEFAZOLIN SODIUM is approved for 8 conditions since its original approval in 1988. These indications span multiple therapeutic areas including oncology, immunology, and more.

Source: FDA Label

CEFAZOLIN SODIUM Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Unlock 8 more competitors across all three rings.
Upgrade to Pro

Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to CEFAZOLIN SODIUM

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

CEFAZOLIN AND DEXTROSE
CEFAZOLIN SODIUM
8 shared
B BRAUN
Shared indications:
CEFAZOLIN IN DEXTROSE
CEFAZOLIN SODIUM
8 shared
Baxter
Shared indications:
CEFOXITIN
CEFOXITIN SODIUM
4 shared
Hikma
Shared indications:
Urinary Tract InfectionsSepticemiaBone and Joint Infections +1 more
📋

Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT00867295 TIVAD 2009/22 Ph 3 completed Effectiveness of Antibiotic Prophylaxis for Totally Implantable Venous Access Device
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

Full development history with FDA approval milestones

|
Loading...
Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

CEFAZOLIN SODIUM FDA Label Details

Indications & Usage

FDA Label (PDF)

Cefazolin for Injection, USP is indicated in the treatment of the following serious infections due to susceptible organisms: Respiratory Tract Infections:Due to S. pneumoniae, Klebsiellaspecies , H. influenzae, S. aureus(penicillin-sensitive and penicillin-resistant), and group A beta-hemolytic streptococci . Injectable benzathine penicillin is considered to be 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 e...

Looking for the branded version?

CEFAZOLIN IN DEXTROSE

Full clinical data, patents, trials, and competitive landscape for cefazolin sodium.

See CEFAZOLIN IN DEXTROSE

Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.