Cefazolin
NDC Package 54868-4651-0

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Cefazolin is 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. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-4651 and is authorized under FDA application ANDA065047.

Identification & Billing

NDC Package Code
54868-4651-0
Package Description
25 VIAL in 1 CARTON / 10 mL in 1 VIAL
Product Code
54868-4651
11-Digit Billing Format
54868465100
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cefazolin
Dosage Form
-
Usage Information
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.Cefazolin for injection, USP is indicated in the treatment of the following serious infections due to susceptible organisms:RESPIRATORY TRACT INFECTIONS due to Streptococcus pneumoniae, Klebsiella species, Haemophilus influenzae, Staphylococcus 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 is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of cefazolin in the subsequent prevention of rheumatic fever are not available at present.URINARY TRACT INFECTIONS due to Escherichia coli, Proteus mirabilis, Klebsiella species and some strains of enterobacter and enterococci.SKIN AND SKIN STRUCTURE INFECTIONS due to Staphylococcus aureus (penicillin-sensitive and penicillin-resistant), group A beta-hemolytic streptococci and other strains of streptococci.BILIARY TRACT INFECTIONS due to Escherichia coli, various strains of streptococci, Proteus mirabilis, Klebsiella species and Staphylococcus aureus.BONE AND JOINT INFECTIONS due to Staphylococcus aureus.GENITAL INFECTIONS (i.e., prostatitis, epididymitis) due to Escherichia coli, Proteus mirabilis, Klebsiella species and some strains of enterococci.SEPTICEMIA due to Streptococcus pneumoniae, Staphylococcus aureus (penicillin-sensitive and penicillin-resistant), Proteus mirabilis, Escherichia coli, and Klebsiella species.ENDOCARDITIS due to Staphylococcus aureus (penicillin-sensitive and penicillin-resistant) and group A beta hemolytic streptococci.Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefazolin.PERIOPERATIVE PROPHYLAXIS: The prophylactic administration of cefazolin 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 70 years of age, with acute cholecystitis, obstructive jaundice or common duct bile stones).The perioperative use of cefazolin 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 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 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 the appropriate therapy may be instituted.(See DOSAGE AND ADMINISTRATION.)

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
ANDA065047
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-15-2003
Listing Expiration
12-31-2017
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

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.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 54868-4651-0 identifies a specific commercial package of 25 vial in 1 carton / 10 ml in 1 vial of Cefazolin, labeled by Physicians Total Care, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Physicians Total Care, Inc. on September 15, 2003. The current certification is valid through December 31, 2017.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868465100. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
54868-4651-0
11-Digit CMS (5-4-2)
54868-4651-00

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.