NDC 44567-707-25 Cefazolin

Injection, Powder, For Solution Intramuscular; Intravenous

NDC Package Code 44567-707-25

The NDC Code 44567-707-25 is assigned to a package of 25 vial in 1 carton > 1 injection, powder, for solution in 1 vial of Cefazolin, a human prescription drug labeled by Wg Critical Care, Llc. The product's dosage form is injection, powder, for solution and is administered via intramuscular; intravenous form.

Field Name Field Value
NDC Code 44567-707-25
Package Description 25 VIAL in 1 CARTON > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
Product Code 44567-707
Proprietary Name Cefazolin What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Cefazolin What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Drug Uses 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.
11-Digit NDC Billing Format 44567070725 NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
Billing Unit EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Estimated Billable Units per Package 25 EA
NADAC Wholesale Price per Unit $0.64608
RxNorm Crosswalk
  • RxCUI: 1665050
  • RxCUI: 1665052
  • Product Type Human Prescription Drug What kind of product is this?
    Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
    Labeler Name Wg Critical Care, Llc
    Dosage Form Injection, Powder, For Solution - A sterile preparation intended for reconstitution to form a solution for parenteral use.
    Administration Route(s)
    • Intramuscular - Administration within a muscle.
    • Intravenous - Administration within or into a vein or veins.
    Active Ingredient(s)
    Pharmacologic Class(es)
    Sample Package No Sample Package?
    This field Indicates whether this package is a sample packaging or not.
    Marketing Category ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
    Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
    FDA Application Number ANDA065303 What is the FDA Application Number?
    This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
    Start Marketing Date 03-06-2015 What is the Start Marketing Date?
    This is the date that the labeler indicates was the start of its marketing of the drug product.
    Listing Expiration Date 12-31-2022 What is the Listing Expiration Date?
    This is the date when the listing record will expire if not updated or certified by the product labeler.
    Exclude Flag N What is the NDC Exclude Flag?
    This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

    NDC Code Structure

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

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    National Average Drug Acquisition Cost (NADAC)

    The National Average Drug Acquisition Cost (NADAC) wholesale price per unit for NDC 44567-707-25 is $0.64608 and is up-to-date as of 06-15-2016. This product is billed for "EA" each discreet unit and contains an estimated amount of 25 billable units per package. The estimated wholesale price for the this package based on the lastest NADAC pricing survey is $.

    The NADAC survey price is the average drug invoice price paid by retail community pharmacies to wholesalers. The Centers for Medicare and Medicaid Services (CMS) compile the NADAC data based on random monthly surveys on more than 60,000 pharmacies from all 50 states and the District of Columbia. NADAC pricing information is NOT the price paid by end-customers but instead the price paid by pharmacies to drug wholesalers and distributors.

    Field Name Field Value
    Price per Unit $0.64608
    Effective Date 06-17-2015 Effective Date
    The effective date of the NADAC Per Unit cost.
    Pricing Unit EA Pricing Unit
    Indicates the pricing unit for the associated NDC (ML, GM or EA).
    Pharmacy Type Indicator C/I - Chain or Independent Pharmacy Pharmacy Type Indicator
    The source of pharmacy survey data used to calculate the NADAC. 'C/I' indicates data was collected from surveys of Chain/Independent pharmacies. Other pharmacy type indicators are not used at this time.
    Explanation Code Code 4: The NADAC was carried forward from the previous file.
    Code 5: The NADAC was calculated based on package size. Explanation Code
    The source of pharmacy survey data used to calculate the NADAC. 'C/I' indicates data was collected from surveys of Chain/Independent pharmacies. Other pharmacy type indicators are not used at this time.
    Classification for Rate Setting G - Generic Classification for Rate Setting
    Indicates whether the NDC was considered brand (B) or generic (G) for the NADAC rate calculation process. If the NDC was considered brand (B) and approved under an Abbreviated New Drug Application (ANDA), the indicator is shown as (B-ANDA).
    As of Date 06-15-2016
    View Pricing Details

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    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 44567-707-25 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    44567070725J0690Cefazolin sodium injection500 MG125250

    * Please review the disclaimer below.