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Cefazolin 10 g Injection, Powder, For Solution, 10 vials — NDC 44567-0708-10 package photo

Cefazolin 10 g Injection, Powder, For Solution, 10 vials

by WG Critical Care, LLC · 10 VIAL in 1 CARTON (44567-708-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
NDC 44567-0708-10
🏷️ FDA NDC (as labeled) 44567-708-10 billing pads the product 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) 44567-708-10
Product NDC 44567-708
11-digit billing NDC 44567070810
NCPDP billing unit EA — each (per item)
RxCUI 313920
UNII P380M0454Z
Application # ANDA065306
SPL Set ID 1999084a-124c-45f9-801f-416a1b942c96
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 2015-03-06
Route INTRAVENOUS
Dosage form INJECTION, POWDER, FOR SOLUTION
Substance CEFAZOLIN SODIUM
GPI-14 02100015102125
GCN Seq No 064591
GCN 15558
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 10 GM VIAL
FDB brand name Cefazolin Sodium
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 44567-708-10 — a 5-3-2 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 product segment → 44567-0708-10. 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

LabelerWG Critical Care, LLC
Application holderACS DOBFAR SPA
FDA applicationANDA065306 (ANDA)
Labeler code44567
First marketedMar 2015
Product typeHuman Prescription Drug
Portfolio85 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 10 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 mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $10.53
Medicare drug plans payPart D · Q2 2026 $9.33
Medicare Part B allowsASP · J0690 $0.796 / J0690 unit
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)44567-708-10
11-digit billing NDC44567-0708-10
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ0690
DescriptorInjection, cefazolin sodium, 500 mg
Billing units / pkg200 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 10 g 00143-9261-10 Hikma 10 vials AP FDA listed
Cefazolin 20 g 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 gthis 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
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

🏛️
2015
On the market since
Mar 2015
📍
2026
Currently FDA-listed
11 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 44567-0708-10, 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
2.5K
Units reimbursed last 4 qtrs
1.9K
Gross reimbursed last 4 qtrs
$20.5K
Avg / prescription
$8.14
Avg / unit
$10.5332
Latest quarter Q4 2025
299Rx
Fee-for-service vs managed care
57% FFS 43% MCO
Fee-for-service · 1,426 Rx Managed care · 1,091 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: 345 units · 17.6 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 233 units · 2.3 per 100k residents MI New York: 126 units · 0.6 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: 186 units · 1.4 per 100k residents PA New Jersey: 6 units · 0.1 per 100k residents NJ Massachusetts: 132 units · 1.9 per 100k residents MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 40 units · 2.0 per 100k residents NE Missouri: 36 units · 0.6 per 100k residents MO Kentucky: 209 units · 4.6 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 12 units · 0.2 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 116 units · 1.6 per 100k residents TN North Carolina: 450 units · 4.2 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 51 units · 0.2 per 100k residents TX Florida: 3 units · 0.0 per 100k residents FL
Units reimbursed · per 100k residents
0.017.6
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 Idaho 17.6 /100k
2 Kentucky 4.6 /100k
3 North Carolina 4.2 /100k
4 Michigan 2.3 /100k
5 Nebraska 2.0 /100k
6 Massachusetts 1.9 /100k
7 Tennessee 1.6 /100k
8 Pennsylvania 1.4 /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
44567-0708-10 You're viewing this 10 VIAL in 1 CARTON (44567-708-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL 2015-03-06 Active

🧭 About this NDC listing & data coverage

Finished prescription product
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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 44567-708-10, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 44567-0708-10, written without dashes as 44567070810. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 44567-0708-10, the first segment (44567) is the labeler code FDA assigned to WG Critical Care, LLC; the middle segment (0708) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (10) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by WG Critical Care, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
WG Critical Care, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J0690 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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 for 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 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 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, 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 ~3 min read

DOSAGE AND ADMINISTRATION THE INTENT OF THE PHARMACY BULK PACKAGE FOR THIS PRODUCT IS FOR PREPARATION OF SOLUTIONS FOR I.V. INFUSION ONLY. 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)* 1 gram to 1.5 grams every 6 hours * In rare instances, doses of up to 12 grams of cefazolin per day have been used.

Perioperative Prophylactic Use : To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are: a. 1 gram I.V. administered ½ 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 I.V. during surgery (administration modified depending on the duration of the operative procedure). c.

500 mg to 1 gram I.V. every 6 to 8 hours for 24 hours postoperatively. It is important that (1) the preoperative dose be given just prior (1/2 hour to 1 hour) 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 3.0 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/q 8 h Vol. (mL) needed with dilution of 125 mg/mL Approximate Single Dose mg/q 6 h Vol. (mL) needed with dilution of 125 mg/mL 10 20 30 40 50 4.5 9 13.6 18.1 22.7 40 mg 75 mg 115 mg 150 mg 190 mg 0.35 mL 0.6 mL 0.9 mL 1.2 mL 1.5 mL 30 mg 55 mg 85 mg 115 mg 140 mg 0.25 mL 0.45 mL 0.7 mL 0.9 mL 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/q 8 h Vol.

(mL) needed with dilution of 225 mg/mL Approximate Single Dose mg/q 6 h Vol. (mL) needed with dilution of 225 mg/mL 10 20 30…

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 162 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 antibacterial 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 EVENTS, contact WG Critical Care, LLC at 1-866-562-4708 or FDA at 1-800-FDA-1088 or www.fda.gov .

🔄 Drug Interactions 77 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 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.

🔄 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 76 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 134 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 I.V. 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 5 times; however, in patients with obstructive biliary disease, bile levels of Cefazolin for Injection are considerably lower than serum levels (less than 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 Testing 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.

📦 How Supplied / Storage and Handling 168 words

HOW SUPPLIED Cefazolin for Injection, USP is supplied in 10 gram or 20 gram Pharmacy Bulk Package bottles. Each Pharmacy Bulk Package contains cefazolin sodium equivalent to 10 grams or 20 grams of cefazolin and is supplied as follows: NDC 44567-708-10 10 gram Pharmacy Bulk Package (carton of 10) NDC 44567-709-10 20 gram Pharmacy Bulk Package (carton of 10) Also available: Cefazolin for Injection, USP equivalent to 500 mg or 1 gram cefazolin per vial is supplied as follows: NDC 44567-706-25 500 mg vial (carton of 25) NDC 44567-707-25 1 gram vial (carton of 25) As with other cephalosporins, cefazolin 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]. CLINITEST is a registered trademark of Miles, Inc.

CLINISTIX is a registered trademark of Bayer Corporation. Manufactured for: WG Critical Care, LLC Paramus, NJ 07652 Made in Italy Revised: March 2019

📋 Description 202 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. Structural Formula: C 14 H 13 N 8 NaO 4 S 3 M.W.

476.5 The pH of the reconstituted solution is between 4 and 6. 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.

Cefazolin for Injection, USP is supplied in 10 or 20 grams Pharmacy Bulk Packages. Each Pharmacy Bulk Package contains cefazolin sodium equivalent to 10 grams 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 parenteral use that contains many single doses. The contents of this pharmacy bulk package are intended for use by a pharmacy admixture service for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion (see DOSAGE AND ADMINISTRATION, Directions for Proper Use of Pharmacy Bulk Package.) FURTHER DILUTION IS REQUIRED.

NOT FOR DIRECT INFUSION. Cefazolin structural formula

💬 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.