Cefazolin
NDC Package 67184-0560-2

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 for injection, USP is indicated in the treatment of the following serious infections due to susceptible organisms:Respiratory Tract Infections: Due to S. Marketed by Qilu Pharmaceutical Co., Ltd., this product is identified by NDC 67184-0560 and is authorized under FDA application ANDA203661.

Identification & Billing

NDC Package Code
67184-0560-2
Package Description
25 VIAL in 1 CARTON / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (67184-0560-1)
Product Code
67184-0560
11-Digit Billing Format
67184056002
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cefazolin
Dosage Form
-
Usage Information
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, 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.

Regulatory & Marketing

Labeler Name
Qilu Pharmaceutical Co., Ltd.
FDA Application #
ANDA203661
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-18-2022
Listing Expiration
12-31-2024
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 67184-0560-2 identifies a specific commercial package of 25 vial in 1 carton / 1 injection, powder, for solution in 1 vial (67184-0560-1) of Cefazolin, labeled by Qilu Pharmaceutical Co., Ltd.. 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 Qilu Pharmaceutical Co., Ltd. on March 18, 2022. The current certification is valid through December 31, 2024.

How is this Qilu Pharmaceutical Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67184056002. 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)
67184-0560-2
11-Digit CMS (5-4-2)
67184-0560-02

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