HomeNDC LookupIngredientsCefazolin › 00143-9924-90
Cefazolin 330 mg/mL Injection, Powder, For Solution, 3 mL — NDC 00143-9924-90 package photo

Cefazolin 330 mg/mL Injection, Powder, For Solution, 3 mL

by Hikma Pharmaceuticals USA Inc. · 3 mL in 1 VIAL (0143-9924-90)
NDC 00143-9924-90
🏷️ FDA NDC (as labeled) 0143-9924-90 billing pads the labeler segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Other active recalls for Cefazolin (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class I · Jun 27, 2025 — 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 (Sandoz Inc) · FDA recall D-0569-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 0143-9924-90
Product NDC 0143-9924
11-digit billing NDC 00143992490
NCPDP billing unit EA — each (per item)
RxCUI 1665050, 1665052
UNII P380M0454Z
Application # ANDA065047
SPL Set ID 1dc9de56-e259-4546-a1db-23119a8a088e
Established class (EPC) Cephalosporin Antibacterial
Chemical class Cephalosporins
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2001-09-18
Route INTRAMUSCULAR, INTRAVENOUS
Dosage form INJECTION, POWDER, FOR SOLUTION
Substance CEFAZOLIN SODIUM
GPI-14 02100015102115
GPI class ceFAZolin Sodium
GCN Seq No 009065
GCN 39903
HICL code 003976
Ingredient (HICL) Cefazolin Sodium
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W1
Therapeutic class — intermediate (HIC2) Antibiotics
HIC3 code W1W
Therapeutic class — specific (HIC3) Cephalosporin Antibiotics - 1St Generation
AHFS code 08:12.06.04
AHFS class 1St Generation Cephalosporin Antibiotics
FDB label name CEFAZOLIN 1 GM VIAL
FDB brand name Cefazolin Sodium
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 0143-9924-90 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00143-9924-90. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Cephalosporin Antibacterial class.

Pharmacologic class Cephalosporin Antibacterial
Drug family (ATC) First-generation cephalosporins
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerHikma Pharmaceuticals USA Inc.
Application holderHIKMA FARMACEUTICA PORTUGAL LDA
FDA applicationANDA065047 (ANDA)
Labeler code00143
First marketedSep 2001
Product typeHuman Prescription Drug
Portfolio724 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name CEFAZOLIN 1 GM VIAL Ingredient Cefazolin Sodium
📖 What it is MedlinePlus · NLM

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 ↗
📗 Our plain-language guide HelloPharmacist
  • 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?
📖 Read our full Cefazolin guide →
7
Nutrient depletion considerations

Cefazolin may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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 systemPer eaPer package
Retail pharmacies payNADAC · weekly $1.030 $1.03 / 1 vial
Medicaid paysCMS SDUD · 12 mo $13.55 $13.55 / 1 vial
Medicare drug plans payPart D · Q2 2026 $1.50 $1.50 / 1 vial
Medicare Part B allowsASP · J0690 $0.796 / J0690 unit
NADAC price history (per ea) — tap or hover for the price & month
Dec 2025 Feb 2026 May 2026 Aug 2026 $1.030 $0.974
▲ Up 6% over the last 9 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🧾 Billing & reimbursement

FDA NDC (as labeled)0143-9924-90
11-digit billing NDC00143-9924-90
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ0690
DescriptorInjection, cefazolin sodium, 500 mg
Billing units / pkg50 units
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cefazolin 330 mg/mL 00143-9262-25 Hikma 25 vials $1.030 AP Availability likely
Cefazolin 330 mg/mLthis 00143-9924-90 Hikma 3 ml $1.030 AP Availability likely
Cefazolin 1 g 00781-3451-96 Sandoz 25 vials $1.030 AP Availability likely
Cefazolin 1 g 44567-0120-25 WG 25 vials $1.030 AP Availability likely
Cefazolin 1 g 44567-0707-25 WG 25 vials $1.030 AP Availability likely
Cefazolin 1 g 60505-6142-05 Apotex 25 vials $1.030 AP Availability likely
Cefazolin 1 g 60505-6243-04 Apotex 25 vials $1.030 AP Availability likely
Cefazolin 1 g/3mL 63323-0237-10 Fresenius 25 vials $1.030 AP Availability likely
Cefazolin 1 g 72572-0055-25 Civica, 25 vials $1.030 AP Availability likely
Cefazolin Sodium 1 g/50mL 00264-3103-11 B. 50 ml Discontinued
Cefazolin 1 g/50mL 00338-3503-41 Baxter 50 ml FDA listed
Cefazolin 1 g 00404-9833-99 Henry 1 vial AP FDA listed
Cefazolin 330 mg/mL 00404-9834-99 Henry 1 vial AP FDA listed
Cefazolin 1 g 00409-2585-01 Hospira, 25 vials FDA listed
Cefazolin 330 mg/mL 50090-4256-00 A-S 25 vials AP FDA listed
Cefazolin 1 g 67184-1001-02 Qilu 25 vials AP FDA listed
Cefazolin 1 g 71205-0679-01 Proficient 1 vial AP FDA listed
Cefazolin 330 mg/mL 71872-7027-01 Medical 1 vial AP FDA listed
Cefazolin 1 g 71872-7141-01 Medical 1 vial AP FDA listed
Cefazolin Sodium 1 g 72189-0584-01 Direct_rx 1 injection AP FDA listed
Cefazolin 1 g 84549-0142-05 ProPharma 1 injection AP FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2001
On the market since
Sep 2001
📍
2026
Currently FDA-listed
25 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00143-9924-90, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
39.5K
Units reimbursed last 4 qtrs
316.5K
Gross reimbursed last 4 qtrs
$4.29M
Avg / prescription
$108.47
Avg / unit
$13.5500
Latest quarter Q4 2025
7.6KRx
Medicaid pays / ea
$13.5500
gross reimbursed
vs
NADAC / ea
$1.0301
acquisition cost
=
Spread
+$12.5199
+1215% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
14% FFS 86% MCO
Fee-for-service · 5,564 Rx Managed care · 33,977 Rx
State Medicaid map
Alaska: 290 units · 39.6 per 100k residents AK Maine: 160 units · 11.5 per 100k residents ME Washington: 372 units · 4.8 per 100k residents WA Idaho: 124 units · 6.3 per 100k residents ID Montana: 243 units · 21.5 per 100k residents MT North Dakota: 577 units · 73.7 per 100k residents ND Minnesota: 3,775 units · 65.8 per 100k residents MN Wisconsin: 20,122 units · 340 per 100k residents WI Michigan: 2,553 units · 25.4 per 100k residents MI New York: 4,335 units · 22.2 per 100k residents NY Vermont: 130 units · 20.1 per 100k residents VT New Hampshire: 1,351 units · 96.4 per 100k residents NH Oregon: 1,306 units · 30.9 per 100k residents OR Nevada: 908 units · 28.4 per 100k residents NV Wyoming: no data reported WY South Dakota: 183 units · 19.9 per 100k residents SD Iowa: 626 units · 19.5 per 100k residents IA Illinois: 465 units · 3.7 per 100k residents IL Indiana: no data reported IN Ohio: 2,334 units · 19.8 per 100k residents OH Pennsylvania: 1,211 units · 9.3 per 100k residents PA New Jersey: 962 units · 10.4 per 100k residents NJ Massachusetts: 2,661 units · 38.0 per 100k residents MA California: 124,232 units · 319 per 100k residents CA Utah: 389 units · 11.4 per 100k residents UT Colorado: 4,878 units · 83.0 per 100k residents CO Nebraska: 348 units · 17.6 per 100k residents NE Missouri: 1,032 units · 16.7 per 100k residents MO Kentucky: 38,890 units · 859 per 100k residents KY West Virginia: 477 units · 26.9 per 100k residents WV Virginia: 1,503 units · 17.2 per 100k residents VA Maryland: 1,403 units · 22.7 per 100k residents MD Connecticut: 3,108 units · 85.9 per 100k residents CT Rhode Island: 5,350 units · 489 per 100k residents RI Arizona: 52 units · 0.7 per 100k residents AZ New Mexico: 1,913 units · 90.5 per 100k residents NM Kansas: 434 units · 14.8 per 100k residents KS Arkansas: 178 units · 5.8 per 100k residents AR Tennessee: 6,694 units · 93.9 per 100k residents TN North Carolina: 67,609 units · 624 per 100k residents NC South Carolina: no data reported SC Delaware: 2,424 units · 235 per 100k residents DE Oklahoma: 260 units · 6.4 per 100k residents OK Louisiana: 1,197 units · 26.2 per 100k residents LA Mississippi: 1,908 units · 64.9 per 100k residents MS Alabama: 715 units · 14.0 per 100k residents AL Georgia: 779 units · 7.1 per 100k residents GA D.C.: no data reported DC Hawaii: 415 units · 28.9 per 100k residents HI Texas: 3,078 units · 10.1 per 100k residents TX Florida: 1,415 units · 6.3 per 100k residents FL
Units reimbursed · per 100k residents
0.7859
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Kentucky 859 /100k
2 North Carolina 624 /100k
3 Rhode Island 489 /100k
4 Wisconsin 340 /100k
5 California 319 /100k
6 Delaware 235 /100k
7 New Hampshire 96.4 /100k
8 Tennessee 93.9 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Cefazolin — the ingredient across all brands.

Top reported reactions

Hypotension702
Anaphylactic Reaction644
Anaphylactic Shock601
Rash592
Pyrexia512
Renal Failure488
Acute Kidney Injury432

Age at onset

Neonate111
Infant24
Child83
Adolescent59
Adult997
Elderly653

Reporter sex

11,986 reports
Male · 51%
Female · 49%
Unknown · 0%

Serious outcomes

Hospitalization6,061
Life-threatening2,101
Death1,387
Disabling302
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,008 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00143-9924-90 You're viewing this 3 mL in 1 VIAL (0143-9924-90) 2001-09-18 Active

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ~2 min read

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. pneumoniae, 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 is effective in 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.

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, 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 ~3 min read

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) ln 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: a.

1 gram IV or IM administered 1/2 hour to 1 hour prior to the start of surgery. b. For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV or IM during surgery (administration modified depending on the duration of the operative procedure). c. 500 mg to 1 gram IV or IM 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 per kg (approximately 10 to 20 mg per pound) 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 per kg (45 mg per pound) 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.

Pediatric Dosage Guide Weight 25 mg/kg/day Divided into 3 Doses 25 mg/kg/day Divided into 4 Doses Lbs Kg Approximate Single Dose mg/q8h Vol. (mL) needed with dilution of 125 mg/mL Approximate Single Dose mg/q6h Vol. (mL) needed with dilution of 125 mg/mL 10 4.5 40 mg 0.35 mL 30 mg 0.25 mL 20 9 75 mg 0.6 mL 55 mg 0.45 mL 30 13.6 115 mg 0.9 mL 85 mg 0.7 mL 40 18.1 150 mg 1.2 mL 115 mg 0.9 mL 50 22.7 190 mg 1.5 mL 140 mg 1.1 mL Weight 50 mg/kg/day Divided into 3 Doses 50 mg/kg/day Divided into 4 Doses Lbs Kg Approximate Single Dose mg/q8h Vol.

(mL) needed with dilution of 225 mg/mL Approximate Single Dose mg/q6h Vol. (mL) needed with dilution of 225 mg/mL 10 4.5 75 mg 0.35 mL 55 mg 0.25 mL 20 9 150 mg 0.7 mL 110 mg 0.5 mL 30 13.6 225 mg 1 mL 170 mg 0.75 mL 40 18.1 300 mg 1…

Contraindications 17 words

CONTRAINDICATIONS Cefazolin for Injection IS CONTRAINDICATED IN PATIENTS WITH KNOWN ALLERGY TO THE CEPHALOSPORIN GROUP OF ANTIBIOTICS.

⚠️ Warnings ~1 min read

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 164 words

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.

Pain at the site of injection after intramuscular administration has occurred infrequently. 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 the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🔄 Drug Interactions 22 words

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 55 words

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 77 words

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 30 words

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 135 words

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 ~3 min read

CLINICAL PHARMACOLOGY After intramuscular administration of Cefazolin for Injection to normal volunteers, the mean serum concentrations were 37 mcg/mL at 1 hour and 3 mcg/mL at 8 hours following a 500 mg dose, and 64 mcg/mL at 1 hour and 7 mcg/mL at 8 hours following a 1 gram dose. 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 a 1 gram dose. The serum half-life for Cefazolin for Injection is approximately 1.8 hours following IV administration and approximately 2 hours following IM 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. Cefazolin for Injection achieves peak urine concentrations of approximately 2,400 mcg/mL and 4,000 mcg/mL respectively following 500 mg and 1 gram intramuscular doses.

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: ht…

🧬 Mechanism of Action 17 words

Mechanism of Action Cefazolin is a bactericidal agent that acts by inhibition of bacterial cell wall synthesis.

📦 How Supplied / Storage and Handling 128 words

HOW SUPPLIED Cefazolin for Injection, USP is supplied in vials containing cefazolin sodium equivalent to 500 mg or 1 gram cefazolin. 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 Also available as Pharmacy Bulk Package, 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 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 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

📋 Description 78 words

DESCRIPTION Cefazolin for Injection, USP is a semi-synthetic cephalosporin for parenteral administration. 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: Each vial contains 48 mg of sodium/1 gram of cefazolin sodium. Cefazolin for Injection, USP is white to off-white crystalline powder, supplied in vials equivalent to 500 mg or 1 gram of cefazolin. Chemical structure

💬 Information for Patients 114 words

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.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.