Cefazolin 20 g Injection, Powder, For Solution, 1 injection
Other active recalls for Cefazolin (different manufacturers) — 1 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Cephalosporin Antibacterial class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Cefazolin injection is used to treat certain infections caused by bacteria. Cefazolin injection also may be used around the time of surgery in order to prevent the patient from getting an infection. Cefazolin injection is in a class of medications called cephalosporin antibiotics. It works by killing bacteria. Antibiotics such as cefazolin injection will not work for colds, flu, or other viral infections. Taking antibiotics when they are not needed may cause them not to work later when you do have an infection from bacteria.
Read the full MedlinePlus article ↗- Cefazolin treats a wide range of serious bacterial infections — things like pneumonia, urinary tract infections, skin infections, bone and joint infections, and even bloodstream in...
- What kinds of infections does cefazolin treat?
- No, cefazolin only comes as an injection. It's either given directly into a vein (IV) or into a muscle (IM), depending on the product being used. A nurse or other healthcare profes...
- How will I receive cefazolin — do I take a pill?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Cefazolin — tap one for details:
Cefazolin may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.
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Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $9.33 | — |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Cefazolin 10 g 00143-9261-10 | Hikma | 10 vials | — | AP | FDA listed | — |
| Cefazolin 20 gthis 00143-9665-10 | Hikma | 1 injection | — | AP | FDA listed | — |
| Cefazolin 10 g 00143-9983-03 | Hikma | 10 vials | — | AP | FDA listed | — |
| Cefazolin 10 g 00781-3452-95 | Sandoz | 10 vials | — | AP | FDA listed | — |
| Cefazolin 10 g 44567-0708-10 | WG | 10 vials | — | — | FDA listed | — |
| Cefazolin 10 g 60505-6143-04 | Apotex | 10 vials | — | AP | FDA listed | — |
| Cefazolin 10 g 60505-6244-04 | Apotex | 10 vials | — | AP | FDA listed | — |
| Cefazolin 10 g 63323-0238-61 | Fresenius | 10 vials | — | — | FDA listed | — |
| Cefazolin 100 g 66288-1100-01 | Samson | 1 injection | — | — | FDA listed | — |
| Cefazolin 300 g 66288-1300-01 | Samson | 1 injection | — | — | FDA listed | — |
| Cefazolin 10 g 72572-0056-10 | Civica, | 10 vials | — | AP | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00143-9665-10 You're viewing this | 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9665-10) | 2004-10-18 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Cefazolin for Injection, USP is indicated in the treatment of the following serious infections due to susceptible organisms: Respiratory Tract Infections: due to S. penumoniae, Klebsiella species, 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 establishing the efficacy of Cefazolin for Injection, USP in the subsequent prevention of rheumatic fever are not available. 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, USP 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, USP 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, USP 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, USP 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, USP and other antibacterial drugs, Cefazolin for Injection, USP 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.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Usual Adult Dosage 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) In rare instances, doses of up to 12 grams of Cefazolin for Injection per day have been used. 1 gram to 1.5 grams every 6 hours Perioperative Prophylactic Use To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are: 1 gram IV administered ½ hour to 1 hour prior to the start of surgery.
For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV during surgery (administration modified depending on the duration of the operative procedure). 500 mg to 1 gram IV every 6 to 8 hours for 24 hours postoperatively. It is important that (1) the preoperative dose be given just (1/2 to 1 hour) prior to the start of surgery so that adequate antibiotic levels are present in the serum and tissues at the time of initial surgical incision; and (2) Cefazolin for Injection be administered, if necessary, at appropriate intervals during surgery to provide sufficient levels of the antibiotic at the anticipated moments of greatest exposure to infective organisms.
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. Dosage Adjustment for Patients with Reduced Renal Function Cefazolin for injection may be used in patients with reduced renal function with the following dosage adjustments: Patients with a creatinine clearance of 55 mL/min or greater or a serum creatinine of 1.5 mg % or less can be given full doses.
Patients with creatinine clearance rates of 35 to 54 mL/min or serum creatinine of 1.6 to 3 mg % can also be given full doses but dosage should be restricted to at least 8 hour intervals. Patients with creatinine clearance rates of 11 to 34 mL/min or serum creatinine of 3.1 to 4.5 mg % should be given 1/2 the usual dose every 12 hours. Patients with creatinine clearance rates of 10 mL/min or less or serum creatinine of 4.6 mg % or greater should be given 1/2 the usual dose every 18 to 24 hours.
All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection. Patients undergoing peritoneal dialysis: See CLINICAL PHARMACOLOGY . Pediatric Dosage In pediatric patients, a total daily dosage of 25 to 50 mg/kg (approximately 10 to 20 mg/lb) of body weight, divided into 3 or 4 equal doses, is effective for most mild to moderately severe infections.
Total daily dosage may be increased to 100 mg/kg (45 mg/lb) of body weight for severe infections. Since safety for use in premature infants and in neonates has not been established, the use of Cefazolin for Injection in these patients is not recommended. In pediatric patients with mild to moderate renal impairment (creatinine clearance of 70 to 40 mL/min), 60% of the normal daily dose given in equally divided doses every 12 hours should be sufficient.
In patients with moderate impairment (creatinine clearance of 40 to 20 mL/min), 25% of the normal daily dose given in equally divided doses every 12 hours should be adequate. Pediatric patients with severe renal impairment (creatinine clearance of 20 to 5 mL/min) may be given 10% of the normal daily dose every 24 hours. All dosage recommendations apply after an initial loading dose.
RECONSTITUTION Preparation of Parenteral Solution Parenteral drug products should be SHAKEN WELL when reconstituted, and inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, th…
⛔ Contraindications ▾
CONTRAINDICATIONS Cefazolin for Injection IS CONTRAINDICATED IN PATIENTS WITH KNOWN ALLERGY TO THE CEPHALOSPORIN GROUP OF ANTIBIOTICS.
⚠️ Warnings ▾
WARNINGS Before therapy with Cefazolin for Injection 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 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 ▾
ADVERSE REACTIONS The following reactions have been reported: Gastrointestinal: Diarrhea, oral candidiasis (oral thrush), vomiting, nausea, stomach cramps, anorexia, and pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment (see WARNINGS ). Nausea and vomiting have been reported rarely.
Allergic: Anaphylaxis, eosinophilia, itching, drug fever, skin rash, Stevens-Johnson syndrome. Hematologic: Neutropenia, leukopenia, thrombocytopenia, thrombocythemia. Hepatic: Transient rise in SGOT, SGPT, and alkaline phosphatase levels has been observed.
As with other cephalosporins, reports of hepatitis have been received. Renal: As with other cephalosporins, reports of increased BUN and creatinine levels, as well as renal failure, have been received. Local Reactions: Rare instances of phlebitis have been reported at site of injection.
Some induration has occurred. Other Reactions: Genital and anal pruritus (including vulvar pruritus, genital moniliasis and vaginitis). To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
🔄 Drug Interactions ▾
Drug 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 ▾
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.
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects ・ Pregnancy Category B. Reproduction studies have been performed in rats, mice, and rabbits at doses up to 25 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to Cefazolin for Injection. There are, however, no adequate and well-controlled studies in pregnant women.
Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness for use in premature infants and neonates have not been established. See DOSAGE AND ADMINISTRATION for recommended dosage in pediatric patients older than 1 month.
🧓 Geriatric Use ▾
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 PRECAUTIONS, General and DOSAGE AND ADMINISTRATION ).
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Studies have shown that following intravenous administration of Cefazolin for Injection to normal volunteers mean serum concentrations peaked at approximately 185 mcg/ mL and were approximately 4 mcg/mL at 8 hours for 1 gram dose. The serum half-life for Cefazolin for Injection is approximately 1.8 hours following intravenous administration. In a study (using normal volunteers) of constant intravenous infusion with dosages of 3.5 mg/kg for 1 hour (approximately 250 mg) and 1.5 mg/kg the next 2 hours (approximately 100 mg), Cefazolin for Injection produced a steady serum level at the third hour of approximately 28 mcg/mL.
Studies in patients hospitalized with infections indicate that Cefazolin for Injection produces mean peak serum levels approximately equivalent to those seen in normal volunteers. Bile levels in patients without obstructive biliary disease can reach or exceed serum levels by up to five times; however, in patients with obstructive biliary disease, bile levels of Cefazolin for Injection are considerably lower than serum levels (<1 mcg/mL). In synovial fluid, the level of Cefazolin for Injection becomes comparable to that reached in serum at about 4 hours after drug administration.
Studies of cord blood show prompt transfer of Cefazolin for Injection across the placenta. Cefazolin for Injection is present in very low concentrations in the milk of nursing mothers. Cefazolin for Injection is excreted unchanged in the urine.
In the first 6 hours approximately 60% of the drug is excreted in the urine and this increases to 70% to 80% within 24 hours. In patients undergoing peritoneal dialysis (2 L/hr), Cefazolin for Injection produced mean serum levels of approximately 10 and 30 mcg/mL after 24 hours’ instillation of a dialyzing solution containing 50 mg/L and 150 mg/L, respectively. Mean peak levels were 29 mcg/mL (range 13 to 44 mcg/mL) with 50 mg/L (3 patients), and 72 mcg/mL (range 26 to 142 mcg/mL) with 150 mg/L (6 patients).
Intraperitoneal administration of Cefazolin for Injection is usually well tolerated. Controlled studies on adult normal volunteers, receiving 1 gram 4 times a day for 10 days, monitoring CBC, SGOT, SGPT, bilirubin, alkaline phosphatase, BUN, creatinine and urinalysis, indicated no clinically significant changes attributed to Cefazolin for Injection. Microbiology Mechanism of Action Cefazolin is a bactericidal agent that acts by inhibition of bacterial cell wall synthesis.
Resistance Predominant mechanisms of bacterial resistance to cephalosporins include the presence of extended-spectrum beta-lactamases and enzymatic hydrolysis. Antimicrobial Activity Cefazolin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE (1 ) section: Gram-positive Bacteria Staphylococcus aureus Staphylococcus epidermidis Streptococcus agalactiae Streptococcus pneumoniae Streptococcus pyogenes Methicillin-resistant staphylococci are uniformly resistant to cefazolin.
Gram-negative Bacteria: Escherichia coli Proteus mirabilis Most isolates of indole positive Proteus ( Proteus vulgaris ), Enterobacter spp., Morganella morganii, Providencia rettgeri, Serratia spp., and Pseudomonas spp . are resistant to cefazolin. Susceptibility Test Methods For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC.
🧬 Mechanism of Action ▾
Mechanism of Action Cefazolin is a bactericidal agent that acts by inhibition of bacterial cell wall synthesis.
📦 How Supplied / Storage and Handling ▾
HOW 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
📋 Description ▾
DESCRIPTION Cefazolin for Injection, USP is a semi-synthetic cephalosporin for parenteral administration. It is the sodium salt of (6R, 7R)-3-[[(5-methyl-1,3,4-thiadiazol-2-yl)]thio]methyl]-8-oxo-7-[2(1H-tetrazol-1-yl)acetoamido]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. The structural formula is as follows: Cefazolin for Injection, USP is a white to cream sterile powder.
The color of Cefazolin for Injection, USP solutions may range from pale yellow to yellow without a change in potency. The pH ranges from 4.0 and 6.0 for a solution containing 100 mg of cefazolin per mL. Cefazolin for Injection, USP is supplied in 10 or 20 grams Pharmacy Bulk Packages.
Each Pharmacy Bulk Package contains Cefazolin Sodium, USP equivalent to 10 or 20 grams of cefazolin. The sodium content is approximately 48 mg (2.1 mEq) per gram of cefazolin sodium. It is to be administered by intravenous route.
A Pharmacy Bulk Package is a container of a sterile preparation for intravenous use that contains many single doses. The contents are intended for use in a pharmacy admixture service and are restricted to the preparation of admixtures for intravenous infusion. FURTHER DILUTION IS REQUIRED BEFORE USE .
Cef Chemical Structure
💬 Information for Patients ▾
Information for Patients Patients should be counseled that antibacterial drugs including Cefazolin for Injection should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Cefazolin for Injection is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed.
Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of the immediate treatment, and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Cefazolin for Injection or other antibacterial drugs in the future.