On this page
Cefazolin
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Cefazolin Sodium | 1 g/1 | 1665050 | View |
| Cefazolin Sodium | 10 g/1 | 1665050 | View |
| Cefazolin Sodium | 2 g/1 | 1665050 | View |
| Cefazolin Sodium | 20 g/1 | 1665050 | View |
| Cefazolin Sodium | 225 mg/mL | 1665050 | View |
| Cefazolin Sodium | 3 g/1 | 1665050 | View |
| Cefazolin Sodium | 330 mg/mL | 1665050 | View |
| Cefazolin Sodium | 500 mg/1 | 1665050 | View |
Forms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Cephalosporin Antibacterial [EPC] | EPC | All 41 members |
| Cephalosporins [CS] | CS | All 41 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 203661-001 | CEFAZOLIN SODIUM | INJECTABLE | CEFAZOLIN SODIUM | Prescription | AP | ||
| 203661-002 | CEFAZOLIN SODIUM | INJECTABLE | CEFAZOLIN SODIUM | Prescription | — | ||
| 203661-003 | CEFAZOLIN SODIUM | INJECTABLE | CEFAZOLIN SODIUM | Prescription | — |
Therapeutic equivalence
Source: Orange BookWhat this rating means: Therapeutically equivalent — bioequivalence demonstrated (parenteral aqueous solutions)
Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 6 | Labeling | Approved | February 24, 2022 | Standard |
| Original application | 1 | Approved | December 28, 2015 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260227). This is the manufacturer's labelling text, not a summary and not advice.
Recent Major Changes
openFDA Drug LabelingRECENT MAJOR CHANGES Dosage and Administration ( 2.1 , 2.2 , 2.3 , 2.6 ) 06/2024 Dosage and Administration ( 2.1 , 2.2 , 2.3 , 2.6 ) 12/2024
Indications and Usage
openFDA Drug Labeling1 INDICATIONS AND USAGE Cefazolin for Injection is a cephalosporin antibacterial indicated for: Treatment of the following infections caused by susceptible isolates of the designated microorganisms in adult and pediatric patients 1 month of age and older for whom appropriate dosing with this formulation can be achieved: Respiratory tract infections ( 1.1 ) Urinary tract infections ( 1.2 ) Skin and skin structure infections ( 1.3 ) Biliary tract infections ( 1.4 ) Bone and joint infections ( 1.5 ) Genital infections ( 1.6 ) Septicemia ( 1.7 ) Endocarditis ( 1.8 ) Perioperative prophylaxis in adult patients ( 1.9 ) 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 bacteria ( 1.10 ) 1.1 Respiratory Tract Infections Cefazolin for Injection is indicated for the treatment of respiratory tract infections due to Streptococcus pneumoniae, Klebsiella species, Hemophilus influenzae, Staphylococcus aureus (methicillin-susceptible), and Group A beta-hemolytic streptococciin adults and pediatric patients 1 month of age and older for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2.1 , 2.2 , 2.4 and 2.5) ]. Limitations of Use 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 is indicated for the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of Cefazolin for Injection in the subsequent prevention of rheumatic fever are not available at present. 1.2 Urinary Tract Infections Cefazolin for Injection is indicated for the treatment of urinary tract infections due to Escherichia coli, Proteus mirabilis, and Klebsiella species (spp.) in adults and pediatric patients 1 month of age and older for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2.1 , 2.2 , 2.4 and 2.5) ]. 1.3 Skin and Skin Structure Infections Cefazolin for Injection is indicated for the treatment of skin and skin structure infections due to S. aureus (methicillin-susceptible) , Group A beta-hemolytic streptococci, and Streptococcus species (spp.) in adults and pediatric patients 1 month of age and older for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2.1 , 2.2 , 2.4 and 2.5) ]. 1.4 Biliary Tract Infections Cefazolin for Injection is indicated for the treatment of biliary tract infections due to E. coli, various isolates of Streptococcus spp. , P. mirabilis, Klebsiella spp., and S. aureus (methicillin-susceptible ) in adults and pediatric patients 1 month of age and older for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2.1 , 2.2 , 2.4 and 2.5) ]. 1.5 Bone and Joint Infections Cefazolin for Injection is indicated for the treatment of bone and joint infections due to S. aureus in adults and pediatric patients 1 month of age and older for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2.1 , 2.2 , 2.4 and 2.5) ]. 1.6 Genital Infections Cefazolin for Injection is indicated for the treatment of genital infections (i.e., prostatitis, epididymitis) due to E. coli, P. mirabilis, and Klebsiella species in adults and pediatric patients 1 month of age and older for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2.1 , 2.2 , 2.4 and 2.5) ]. 1.7 Septicemia Cefazolin for Injection is indicated for the treatment of septicemia due to S. pneumoniae, S. aureus (methicillin-susceptible), P. mirabilis, E. coli, and Klebsiella species in adults and pediatric patients 1 month of age and older for whom appropriate dosing w …
Dosage and Administration
openFDA Drug Labeling2 DOSAGE AND ADMINISTRATION Cefazolin for Injection, 2 grams/vial: For intravenous infusion ( 2.1 ) For intravenous bolus injection ( 2.1 ) Not for intramuscular administration ( 2.1 ) Cefazolin for Injection, 3 grams/vial: For intravenous infusion only ( 2.1 ) Not for intravenous bolus injection administration or intramuscular administration ( 2.1 ) Recommended Dosage in Adult Patients with CLcr that is greater than or equal to 55 mL/min ( 2.2 ) Type of Infection Dose Frequency Moderate to severe infections 500 mg to 1 gram every 6 to 8 hours Mild infections caused by susceptible gram-positive cocci 250 mg to 500 mg every 8 hours Acute, uncomplicated urinary tract infections 1 gram every 12 hours Pneumococcal pneumonia 500 mg every 12 hours Severe, life-threatening infections (e.g., endocarditis, septicemia)* 1 gram to 1.5 grams every 6 hours Perioperative prophylaxis 1 gram to 2 grams 1/2 to 1 hour prior to start of surgery 500 mg to 1 gram during surgery for lengthy procedures (e.g., 2 hours or more) 500 mg to 1 gram every 6 to 8 hours for 24 hours postoperatively * In rare instances, doses of up to 12 grams of cefazolin per day have been used. Recommended Dosage in Pediatric Patients with CLcr that is greater than or equal to 70 mL/min ( 2.3 ) Type of Infection Dose Frequency Mild to moderately severe infections 25 mg per kg to 50 mg per kg divided into 3 or 4 equal doses Severe infections May increase to 100 mg per kg divided into 3 or 4 equal doses Dosage adjustment is required for adult patients with CLcr that is less than 55 mL/min and pediatric patients with CLcr that is less than 70 mL/min ( 2.4 ) See full prescribing information for preparation and administration instructions ( 2.6 ) 2.1 Important Administration Instructions Cefazolin for Injection, 2 grams/vial: Cefazolin for Injection, 2 grams/vial, is for intravenous infusion or intravenous bolus injection in adult and pediatric patients [see Dosage and Administration (2.2 , 2.3 , and 2.6 )] . Not for intramuscular administration. Cefazolin for Injection, 3 grams/vial: Cefazolin for Injection, 3 grams/vial, is for intravenous infusion only in adult and pediatric patients [see Dosage and Administration ( 2.2 , 2.3 , 2.5 , and 2.6 )] . Cefazolin for Injection, 3 grams/vial is not for intravenous bolus injection or intramuscular administration [see Dosage and Administration (2.5 , 2.6) ] . 2.2 Recommended Dosage for the Treatment of Infections Recommended Dosage for the Treatment of Infections in Adults with Creatinine Clearance (CLcr) Equal to 55 mL/min or Greater The recommended adult dosages of Cefazolin for Injection for the treatment of infections [see Indications and Usage (1.1 to 1.8) ] are outlined in Table 1 below. Administration instructions are as follows: Cefazolin for Injection, 2 grams/vial is for intravenous infusion or intravenous bolus injection in adult patients [see Dosage and Administration (2.6) ] . Cefazolin for Injection, 3 grams/vial is only for intravenous infusion in adult patients. Cefazolin for Injection, 3 grams/vial is not for intravenous bolus injection in adult patients [see Dosage and Administration (2.6) ] . Cefazolin for Injection 2 grams/vial and 3 grams/vial are not for intramuscular injection. Table 1: Recommended Dosage in Adult Patients with CLcr Equal to 55 mL/min or Greater Site and Type of Infection Dose Frequency Moderate to severe infections 500 mg to 1 gram every 6 to 8 hours Mild infections caused by susceptible gram–positive cocci 250 mg to 500 mg every 8 hours Acute, uncomplicated urinary tract infections 1 gram every 12 hours Pneumococcal pneumonia 500 mg every 12 hours Severe, life-threatening infections (e.g., endocarditis, septicemia)* 1 gram to 1.5 grams every 6 hours * ln rare instances, doses of up to 12 grams of Cefazolin for Injection per day have been used. Recommended Dosage for the Treatment of Infections in Pediatric Patients 1 Month of Age and Older with CLcr Equal to 70 mL/min or Greater The recommended …
Dosage Forms and Strengths
openFDA Drug Labeling3 DOSAGE FORMS AND STRENGTHS Cefazolin for Injection is available as 2 grams or 3 grams of cefazolin as a white to off-white crystalline powder in single-dose vial for reconstitution. For Injection: 2 grams or 3 grams of cefazolin as a powder in single-dose vial for reconstitution ( 3 )
Contraindications
openFDA Drug Labeling4 CONTRAINDICATIONS Hypersensitivity to cefazolin or other cephalosporin class antibacterial drugs, penicillins, or other beta-lactams. ( 4.1 ) 4.1 Hypersensitivity to Cefazolin or the Cephalosporin Class of Antibacterial Drugs, Penicillins, or Other Beta-lactams Cefazolin for injection is contraindicated in patients who have a history of immediate hypersensitivity reactions (e.g., anaphylaxis, serious skin reactions) to cefazolin or the cephalosporin class of antibacterial drugs, penicillins, or other beta-lactams [ see Warnings and Precautions (5.1) ].
Warnings and Cautions
openFDA Drug Labeling5 WARNINGS AND PRECAUTIONS • Hypersensitivity Reactions: Cross-hypersensitivity may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction occurs, discontinue the drug. (5.1) • Clostridioides difficile -Associated Diarrhea (CDAD) : May range from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs. (5.3) • Prothrombin Activity : May be associated with a fall in prothrombin activity. Prothrombin time should be monitored in patients at risk and exogenous vitamin K administered as indicated (5.5) 5.1 Hypersensitivity Reactions to Cefazolin, Cephalosporins, Penicillins, or Other Beta-lactams Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterial drugs. Before therapy with Cefazolin for Injection is instituted, careful inquiry should be made to determine whether the patient has had previous immediate hypersensitivity reactions to cefazolin, cephalosporins, penicillins, or carbapenems. Exercise caution if this product is to be given to penicillin-sensitive patients because cross-hypersensitivity among beta-lactam antibacterial drugs has been clearly documented and may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction to Cefazolin for Injection occurs, discontinue the drug. 5.2 Seizures in Patients with Renal Impairment Seizures may occur with the administration of Cefazolin for Injection, particularly in patients with renal impairment [see Use in Specific Populations (8.6)] . Discontinue Cefazolin for Injection if seizures occur. Anticonvulsant therapy should be continued in patients with known seizure disorders. 5.3 Clostridioides difficile -Associated Diarrhea Clostridioides difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cefazolin for injection, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B, which contribute to the development of CDAD. Hypertoxin-producing isolates of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated. 5.4 Risk of Development of Drug-resistant Bacteria Prescribing Cefazolin for Injection in the absence of proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. As with other antimicrobials, prolonged use of Cefazolin for Injection may result in overgrowth of nonsusceptible microorganisms. Repeated evaluation of the patient's condition is essential. Should superinfection occur during therapy, appropriate measures should be taken. 5.5 Prothrombin Activity Cefazolin for Injection may be associated with a fall in prothrombin activity. Those at risk include patients with renal or hepatic impairment or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy. Prothrombin time should be monitored in patients at risk and exogenous vitamin K administered as indicated. 5.6 Drug/Laboratory Test Interactions Urinary Glucose The administration of cefazolin …
Warnings
openFDA Drug LabelingWARNINGS BEFORE THERAPY WITH CEFAZOLIN FOR INJECTION, USP IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFAZOLIN, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-HYPERSENSITIVITY AMONG BETA-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO CEFAZOLIN FOR INJECTION, USP OCCURS, DISCONTINUE TREATMENT WITH THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, IV FLUIDS, IV ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED. Pseudomembranous colitis has been reported with nearly all antibacterial agents, including cefazolin, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of "antibiotic-associated colitis." After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an oral antibacterial drug clinically effective against C.difficile colitis.
Adverse Reactions
openFDA Drug Labeling6 ADVERSE REACTIONS The following serious adverse reactions to cefazolin for injection are described below and elsewhere in the labeling: • Hypersensitivity Reactions to Cefazolin, Cephalosporins, Penicillins, or Other Beta-lactams [see Warnings and Precautions (5.1)] • Seizures in Patients with Renal Impairment [see Warnings and Precautions (5.2)] • Clostridioides difficile -Associated Diarrhea [see Warnings and Precautions (5.3)] Adult Patients : Most common adverse reactions: gastrointestinal (nausea, vomiting, diarrhea), and allergic reactions (anaphylaxis, urticaria, skin rash). (6) To report SUSPECTED ADVERSE REACTIONS, contact WG Critical Care, LLC at 1-866-562-4708 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following adverse reactions were reported from clinical trials: Gastrointestinal: Diarrhea, oral candidiasis (oral thrush), mouth ulcers, vomiting, nausea, stomach cramps, epigastric pain, heartburn, flatus, anorexia and pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment [see Warnings and Precautions (5.3)] . Allergic: Anaphylaxis, eosinophilia, urticaria, itching, drug fever, skin rash, Stevens-Johnson syndrome. Hematologic: Neutropenia, leukopenia, thrombocytopenia, thrombocythemia. Hepatic: Transient rise in serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT), and alkaline phosphatase levels has been observed. Reports of hepatitis have been received. Renal: Reports of increased BUN and creatinine levels, as well as renal failure, have been received. Local Reactions: Instances of phlebitis have been reported at site of injection. Some induration has occurred. Other Reactions: Pruritus (including genital, vulvar and anal pruritus, genital moniliasis, and vaginitis). Dizziness, fainting, lightheadedness, confusion, weakness, tiredness, hypotension, somnolence and headache. 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of cefazolin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Immune system disorders: Serum sickness-like reaction Renal and urinary disorders: Acute tubulointerstitial nephritis (ATIN) Skin and subcutaneous tissue disorders: Acute generalized exanthematous pustulosis (AGEP) 6.3 Cephalosporin-class Adverse Reactions In addition to the adverse reactions listed above that have been observed in patients treated with cefazolin, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibacterials: Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, renal impairment, toxic nephropathy, aplastic anemia, hemolytic anemia, hemorrhage, a fall in prothrombin activity, hepatic impairment including cholestasis, and pancytopenia.
Drug Interactions
openFDA Drug LabelingDrug Interactions Probenecid may decrease renal tubular secretion of cephalosporins when used concurrently, resulting in increased and more prolonged cephalosporin blood levels. Drug/Laboratory Test Interactions A false positive reaction for glucose in the urine may occur with Benedict’s solution, Fehling’s solution or with CLINITEST ® tablets, but not with enzyme-based tests such as CLINISTIX ® . Positive direct and indirect antiglobulin (Coombs) tests have occurred; these may also occur in neonates whose mothers received cephalosporins before delivery.
Use in Specific Populations
openFDA Drug Labeling8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary Available data from published prospective cohort studies, case series and case reports over several decades with cefazolin use in pregnant women have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. These studies have methodologic limitations, including small sample size, retrospective study design, and inconsistent comparator groups. Cefazolin crosses the placenta. Animal reproduction studies performed in rats, mice and rabbits administered cefazolin during organogenesis at doses 1 to 3 times the maximum recommended human dose (MRHD) did not demonstrate adverse developmental outcomes. In rats subcutaneously administered cefazolin prior to delivery and throughout lactation, there were no adverse effects on offspring at a dose approximately 2 times the MRHD (see Data) The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Reproduction studies have been performed in rats, mice and rabbits administered cefazolin subcutaneously during organogenesis at doses of 2000, 2400 and 240 mg/kg/day (approximately 1 to 3 times the maximum recommended human dose on a body surface area comparison). There was no evidence of any adverse effects on embryofetal development due to cefazolin. In a peri-postnatal study in rats, cefazolin administered subcutaneously up to 1200 mg/kg/day (approximately 2 times the MRHD based on body surface area comparison) to pregnant dams prior to delivery and through lactation caused no adverse effects on offspring. 8.2 Lactation Risk Summary Data from published literature report that cefazolin is present in human milk but is not expected to accumulate in a breastfed infant. There are no data on the effects of cefazolin on the breastfed child or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Cefazolin for Injection and any potential adverse effects on the breastfed child from Cefazolin for Injection or from the underlying maternal condition. 8.4 Pediatric Use Cefazolin for Injection is indicated for the treatment of respiratory tract infections, urinary tract infections, skin and skin structure infections, biliary tract infections, bone and joint infections, genital infections, septicemia, and endocarditis in pediatric patients 1 month of age and older for whom appropriate dosing with this formulation can be achieved [see Indications and Usage (1.1 to 1.8) and Dosage and Administration (2.2) ] . Safety and effectiveness of Cefazolin for Injection in premature infants and neonates have not been established. 8.5 Geriatric Use Of the 920 subjects who received cefazolin for injection in clinical studies, 313 (34%) were 65 years and over, while 138 (15%) were 75 years and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see Dosage and Administration (2.4) and Warnings and Precautions (5.2) ] . 8.6 Renal Impairment When Cefazolin for Injection is administered to patients with low urinary output because …
Mechanism of Action
openFDA Drug LabelingMechanism of Action Cefazolin is a bactericidal agent that acts by inhibition of bacterial cell wall synthesis.
Description
openFDA Drug Labeling11 DESCRIPTION Cefazolin for Injection contains cefazolin sodium, a semi-synthetic cephalosporin. It is the sodium salt of 3-{[(5-methyl-1,3,4-thiadiazol-2-yl)thio]-methyl}-8-oxo-7-[2-(1H-tetrazol-1-yl) acetamido]-5-thia-1-azabicyclo [4.2.0]oct-2-ene-2-carboxylic acid. The molecular formula is C 14 H 13 N 8 NaO 4 S 3 and molecular weight is 476.49. Structural Formula: Structural Formula Cefazolin for Injection is supplied as a sterile powder in single-dose vials. The 2 g/vial Cefazolin for Injection contains 2 grams of cefazolin (equivalent to 2.097 g of cefazolin sodium). The 3 g/vial Cefazolin for Injection contains 3 grams of cefazolin (equivalent to 3.144 grams of cefazolin sodium). The 2 g/vial Cefazolin for Injection contains 96 mg of sodium. The 3 g/vial Cefazolin for Injection contains 144 mg of sodium. After reconstitution with sterile water for injection, the drug product solution has a pH of 4.0 to 6.0. Cefazolin for Injection, 2 grams/vial, is intended for intravenous infusion or intravenous bolus injection. Cefazolin for Injection, 2 grams/vial is not for intramuscular administration. Cefazolin for Injection, 3 grams/vial, is intended for intravenous infusion only. Cefazolin for Injection, 3 grams/vial is not for intravenous bolus injection or intramuscular administration in adult or pediatric patients [see Dosage and Administration (2.1 , 2.2 , 2.3 )] . Structural Formula
Overdosage
openFDA Drug Labeling10 OVERDOSAGE Accidental overdosage resulting in seizures may occur in patients with renal impairment who receive doses greater than the recommended dosage of Cefazolin for Injection [see Warnings and Precautions (5.2) ] . If seizures associated with accidental overdosage occur, discontinue Cefazolin for Injection and give supportive treatment.
How Supplied / Storage and Handling
openFDA Drug LabelingHOW SUPPLIED Cefazolin for Injection, USP, is supplied in 10 and 20 grams Pharmacy Bulk Package vials. Each Pharmacy Bulk Package contains cefazolin sodium equivalent to 10 or 20 grams of cefazolin, as follows: Cefazolin for Injection, USP Vial Size Packaged NDC No. 10 grams 100 mL Carton of 10 vials 0143-9983-03 20 grams 100 mL Carton of 10 vials 0143-9665-10 Also available as: Cefazolin for Injection, USP Vial Size Packaged NDC No. 500 mg 10 mL Carton of 25 vials 0143-9923-90 1 gram 10 mL Carton of 25 vials 0143-9924-90 Preservative Free. As with other cephalosporins, Cefazolin for Injection, USP tends to darken depending on storage conditions; within the stated recommendations; however, product potency is not adversely affected. Before reconstitution, protect from light and store at 20o to 25oC (68o to 77oF) [see USP Controlled Room Temperature]. This container closure is not made with natural rubber latex. CLINITEST is a registered trademark of Miles, Inc. CLINISTIX is a registered trademark of Bayer Corporation. Manufactured by: HIKMA FARMACÊUTICA (PORTUGAL) S.A. Estrada do Rio da Mó, no8, 8A and 8B – Fervença 2705-906 Terrugem SNT PORTUGAL Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Revised: September 2020 PIN089-WES/7
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: CEFAZOLIN SODIUM. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Recalls
Source: FDA Enforcement| Classification | Reported | Firm | Reason | Status |
|---|---|---|---|---|
| Class I | July 9, 2025 | Sandoz Inc | Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin | Ongoing |
| Class II | June 2, 2021 | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Terminated |
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 50090-4256-0 | 50090-4256 | A-S Medication Solutions | 25 VIAL in 1 BOX (50090-4256-0) / 3 mL in 1 VIAL | April 5, 2019 |
| 60505-6142-5 | 60505-6142 | Apotex Corp. | 25 VIAL, SINGLE-DOSE in 1 CARTON (60505-6142-5) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (60505-6142-0) | June 30, 2017 |
| 60505-6143-4 | 60505-6143 | Apotex Corp. | 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (60505-6143-4) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE (60505-6143-0) | March 28, 2019 |
| 60505-6231-5 | 60505-6231 | Apotex Corp. | 25 VIAL, SINGLE-DOSE in 1 CARTON (60505-6231-5) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (60505-6231-0) | March 18, 2022 |
| 60505-6243-4 | 60505-6243 | Apotex Corp. | 25 VIAL, SINGLE-DOSE in 1 CARTON (60505-6243-4) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (60505-6243-0) | September 1, 2022 |
| 60505-6244-4 | 60505-6244 | Apotex Corp. | 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (60505-6244-4) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE (60505-6244-0) | September 1, 2022 |
| 60505-6266-5 | 60505-6266 | Apotex Corp. | 25 VIAL, SINGLE-DOSE in 1 CARTON (60505-6266-5) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (60505-6266-0) | February 13, 2024 |
| 72572-054-25 | 72572-054 | Civica, Inc. | 25 VIAL in 1 CARTON (72572-054-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72572-054-01) | August 18, 2026 |
| 72572-055-25 | 72572-055 | Civica, Inc. | 25 VIAL in 1 CARTON (72572-055-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72572-055-01) | March 1, 2022 |
| 72572-056-10 | 72572-056 | Civica, Inc. | 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (72572-056-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE (72572-056-01) | March 1, 2022 |
| 0404-9835-99 | 0404-9835 | Henry Schein Inc. | 1 VIAL in 1 BAG (0404-9835-99) / 2.2 mL in 1 VIAL | January 9, 2022 |
| 0404-9833-99 | 0404-9833 | Henry Schein, Inc. | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9833-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE | January 9, 2022 |
| 0404-9834-99 | 0404-9834 | Henry Schein, Inc. | 1 VIAL in 1 BAG (0404-9834-99) / 3 mL in 1 VIAL | January 9, 2022 |
| 0143-9139-25 | 0143-9139 | Hikma Pharmaceuticals USA Inc. | 25 VIAL in 1 CARTON (0143-9139-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL | March 1, 2023 |
| 0143-9140-25 | 0143-9140 | Hikma Pharmaceuticals USA Inc. | 25 VIAL in 1 CARTON (0143-9140-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL | March 1, 2023 |
| 0143-9261-10 | 0143-9261 | Hikma Pharmaceuticals USA Inc. | 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0143-9261-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE (0143-9261-01) | October 18, 2004 |
| 0143-9262-25 | 0143-9262 | Hikma Pharmaceuticals USA Inc. | 25 VIAL in 1 CARTON (0143-9262-25) / 3 mL in 1 VIAL (0143-9262-01) | September 18, 2001 |
| 0143-9665-10 | 0143-9665 | Hikma Pharmaceuticals USA Inc. | 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9665-10) | October 18, 2004 |
| 0143-9923-90 | 0143-9923 | Hikma Pharmaceuticals USA Inc. | 2.2 mL in 1 VIAL (0143-9923-90) | September 18, 2001 |
| 0143-9924-90 | 0143-9924 | Hikma Pharmaceuticals USA Inc. | 3 mL in 1 VIAL (0143-9924-90) | September 18, 2001 |
| 0143-9983-03 | 0143-9983 | Hikma Pharmaceuticals USA Inc. | 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0143-9983-03) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE (0143-9983-91) | October 18, 2004 |
| 0409-2585-01 | 0409-2585 | Hospira, Inc | 25 VIAL in 1 CARTON (0409-2585-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0409-2585-11) | August 7, 2007 |
| 71872-7027-1 | 71872-7027 | Medical Purchasing Solutions, LLC | 1 VIAL in 1 BAG (71872-7027-1) / 3 mL in 1 VIAL | February 28, 2018 |
| 71872-7141-1 | 71872-7141 | Medical Purchasing Solutions, LLC | 1 VIAL, SINGLE-DOSE in 1 BAG (71872-7141-1) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE | July 13, 2018 |
| 84549-142-05 | 84549-142 | ProPharma Distribution | 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (84549-142-05) | September 1, 2025 |
| 71205-679-01 | 71205-679 | Proficient Rx LP | 1 VIAL, SINGLE-DOSE in 1 BOX (71205-679-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE | August 1, 2022 |
| 67184-1001-2 | 67184-1001 | Qilu Pharmaceutical Co., Ltd. | 25 VIAL in 1 CARTON (67184-1001-2) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL | December 28, 2015 |
| 0781-3451-95 | 0781-3451 | Sandoz Inc | 10 VIAL in 1 CARTON (0781-3451-95) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0781-3451-70) | January 5, 2026 |
| 0781-3451-96 | 0781-3451 | Sandoz Inc | 25 VIAL in 1 CARTON (0781-3451-96) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0781-3451-70) | December 9, 1988 |
| 0781-3452-95 | 0781-3452 | Sandoz Inc | 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0781-3452-95) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE (0781-3452-46) | December 9, 1988 |
| 44567-120-25 | 44567-120 | WG Critical Care, LLC | 25 VIAL in 1 CARTON (44567-120-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL | April 23, 2019 |
| 44567-706-25 | 44567-706 | WG Critical Care, LLC | 25 VIAL in 1 CARTON (44567-706-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL | March 6, 2015 |
| 44567-707-25 | 44567-707 | WG Critical Care, LLC | 25 VIAL in 1 CARTON (44567-707-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL | March 6, 2015 |
| 44567-708-10 | 44567-708 | WG Critical Care, LLC | 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (44567-708-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE | March 6, 2015 |
| 44567-840-25 | 44567-840 | WG Critical Care, LLC | 25 VIAL in 1 CARTON (44567-840-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (44567-840-01) | May 18, 2023 |
| 44567-845-25 | 44567-845 | WG Critical Care, LLC | 25 VIAL in 1 CARTON (44567-845-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (44567-845-01) | May 10, 2024 |
| 50090-4256 | 50090-4256 | A-S Medication Solutions | — | September 18, 2001 |
| 60505-6142 | 60505-6142 | Apotex Corp. | — | June 30, 2017 |
| 60505-6143 | 60505-6143 | Apotex Corp. | — | March 28, 2019 |
| 60505-6231 | 60505-6231 | Apotex Corp. | — | March 18, 2022 |
| 60505-6243 | 60505-6243 | Apotex Corp. | — | September 1, 2022 |
| 60505-6244 | 60505-6244 | Apotex Corp. | — | September 1, 2022 |
| 60505-6266 | 60505-6266 | Apotex Corp. | — | February 13, 2024 |
| 72572-054 | 72572-054 | Civica, Inc. | — | August 18, 2026 |
| 72572-055 | 72572-055 | Civica, Inc. | — | March 1, 2022 |
| 72572-056 | 72572-056 | Civica, Inc. | — | March 1, 2022 |
| 0404-9835 | 0404-9835 | Henry Schein Inc. | — | January 9, 2022 |
| 0404-9833 | 0404-9833 | Henry Schein, Inc. | — | January 9, 2022 |
| 0404-9834 | 0404-9834 | Henry Schein, Inc. | — | January 9, 2022 |
| 0143-9139 | 0143-9139 | Hikma Pharmaceuticals USA Inc. | — | March 1, 2023 |
| 0143-9140 | 0143-9140 | Hikma Pharmaceuticals USA Inc. | — | March 1, 2023 |
| 0143-9261 | 0143-9261 | Hikma Pharmaceuticals USA Inc. | — | October 18, 2004 |
| 0143-9262 | 0143-9262 | Hikma Pharmaceuticals USA Inc. | — | September 18, 2001 |
| 0143-9665 | 0143-9665 | Hikma Pharmaceuticals USA Inc. | — | October 18, 2004 |
| 0143-9923 | 0143-9923 | Hikma Pharmaceuticals USA Inc. | — | September 18, 2001 |
| 0143-9924 | 0143-9924 | Hikma Pharmaceuticals USA Inc. | — | September 18, 2001 |
| 0143-9983 | 0143-9983 | Hikma Pharmaceuticals USA Inc. | — | October 18, 2004 |
| 0409-2585 | 0409-2585 | Hospira, Inc | — | May 9, 2007 |
| 71872-7027 | 71872-7027 | Medical Purchasing Solutions, LLC | — | September 18, 2001 |
| 71872-7141 | 71872-7141 | Medical Purchasing Solutions, LLC | — | June 30, 2017 |
| 84549-142 | 84549-142 | ProPharma Distribution | — | June 30, 2017 |
| 71205-679 | 71205-679 | Proficient Rx LP | — | June 30, 2017 |
| 67184-1001 | 67184-1001 | Qilu Pharmaceutical Co., Ltd. | — | December 28, 2015 |
| 0781-3450 | 0781-3450 | Sandoz Inc | — | December 9, 1988 |
| 0781-3451 | 0781-3451 | Sandoz Inc | — | December 9, 1988 |
| 0781-3452 | 0781-3452 | Sandoz Inc | — | December 9, 1988 |
| 44567-120 | 44567-120 | WG Critical Care, LLC | — | April 23, 2019 |
| 44567-706 | 44567-706 | WG Critical Care, LLC | — | March 6, 2015 |
| 44567-707 | 44567-707 | WG Critical Care, LLC | — | March 6, 2015 |
| 44567-708 | 44567-708 | WG Critical Care, LLC | — | March 6, 2015 |
| 44567-840 | 44567-840 | WG Critical Care, LLC | — | May 18, 2023 |
| 44567-845 | 44567-845 | WG Critical Care, LLC | — | May 10, 2024 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Orange Book | FDA | Therapeutic equivalence codes, reference drug flags, patents, exclusivity |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
| Enforcement | FDA | Recall records |
Generated September 25, 2026 · 13 sections on this page.