Defencath
NDC Package 72990-105-10

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.

Defencath is lIMITED POPULATION: DEFENCATH® is indicated to reduce the incidence of catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC). Marketed by Cormedix Inc., this product is identified by NDC 72990-105 and is authorized under FDA application NDA214520.

Identification & Billing

NDC Package Code
72990-105-10
Package Description
10 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE (72990-105-05)
Product Code
72990-105
11-Digit Billing Format
72990010510
RxNorm Crosswalk
  • RxCUI: 2670461 - heparin sodium, porcine 3,000 UNT / taurolidine 40.5 MG in 3 ML Injection
  • RxCUI: 2670461 - 3 ML heparin sodium, porcine 1000 UNT/ML / taurolidine 13.5 MG/ML Injection
  • RxCUI: 2670461 - heparin sodium, porcine 3,000 UNT / taurolidine 40.5 MG per 3 ML Injection
  • RxCUI: 2670468 - DEFENCATH 3000 UNT / 40.5 MG in 3 ML Injection
  • RxCUI: 2670468 - 3 ML heparin sodium, porcine 1000 UNT/ML / taurolidine 13.5 MG/ML Injection [Defencath]

Clinical Specifications

Proprietary Name
Defencath
Dosage Form
-
Usage Information
LIMITED POPULATION: DEFENCATH® is indicated to reduce the incidence of catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC). This drug is indicated for use in a limited and specific population of patients [see Clinical Studies (14)].Limitations of UseThe safety and effectiveness of DEFENCATH have not been established for use in populations other than adult patients with kidney failure receiving chronic HD through a CVC.

Regulatory & Marketing

Labeler Name
Cormedix Inc.
FDA Application #
NDA214520
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-09-2024
End Marketing Date
04-09-2024
Listing Expiration
04-09-2024
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 72990-105-10 identifies a specific commercial package of 10 vial, single-dose in 1 carton / 5 ml in 1 vial, single-dose (72990-105-05) of Defencath, labeled by Cormedix Inc.. 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 Cormedix Inc. on April 09, 2024. The current certification is valid through April 09, 2024.

How is this Cormedix Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72990010510. 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)
72990-105-10
11-Digit CMS (5-4-2)
72990-0105-10

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