Cefazolin
NDC Package 63323-449-61

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 discontinued by the firm.

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 Fresenius Kabi Usa, Llc, this product is identified by NDC 63323-449 and is authorized under FDA application ANDA065306.

Identification & Billing

NDC Package Code
63323-449-61
Package Description
10 VIAL in 1 CARTON / 100 mL in 1 VIAL (63323-449-01)
Product Code
63323-449
11-Digit Billing Format
63323044961
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 for the treatment of the following infections when caused by susceptible bacteria.

Regulatory & Marketing

Labeler Name
Fresenius Kabi Usa, Llc
FDA Application #
ANDA065306
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-14-2011
End Marketing Date
10-31-2018
Listing Expiration
10-31-2018
Exclude Flag
D
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 63323-449-61 identifies a specific commercial package of 10 vial in 1 carton / 100 ml in 1 vial (63323-449-01) of Cefazolin, labeled by Fresenius Kabi Usa, Llc. 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 Fresenius Kabi Usa, Llc on June 14, 2011. The current certification is valid through October 31, 2018.

How is this Fresenius Kabi Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63323044961. 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 (5-3-2)
63323-449-61
11-Digit CMS (5-4-2)
63323-0449-61

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