Chlora-cleanze
NDC Package 71389-001-03

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

Package Information

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

Chlora-cleanze is use prior to surgery to prepare patient’s skin. Marketed by Biotronix Healthcare Industries, Inc., this product is identified by NDC 71389-001 and is authorized under FDA application part333A.

Identification & Billing

NDC Package Code
71389-001-03
Package Description
1.75 mL in 1 POUCH
Product Code
71389-001
11-Digit Billing Format
71389000103
RxNorm Crosswalk
  • RxCUI: 1918214 - chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Medicated Pad
  • RxCUI: 1918214 - chlorhexidine gluconate 20 MG/ML / isopropyl alcohol 0.7 ML/ML Medicated Pad
  • RxCUI: 1918214 - chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Topical Swab

Clinical Specifications

Proprietary Name
Chlora-cleanze
Dosage Form
-
Usage Information
Use prior to surgery to prepare patient’s skin. Helps in the reduction of potentially harmful bacteria which can cause skin infections.

Regulatory & Marketing

Labeler Name
Biotronix Healthcare Industries, Inc.
FDA Application #
part333A
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
04-18-2017
Listing Expiration
12-31-2021
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (71389-001). Click a package code to view its specific billing and regulatory data.

71389-001-01
.67 mL in 1 POUCH
71389-001-02
1.5 mL in 1 POUCH
71389-001-04
3 mL in 1 POUCH

* 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 71389-001-03 identifies a specific commercial package of 1.75 ml in 1 pouch of Chlora-cleanze, labeled by Biotronix Healthcare Industries, 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 Biotronix Healthcare Industries, Inc. on April 18, 2017. The current certification is valid through December 31, 2021.

How is this Biotronix Healthcare Industries, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71389000103. 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)
71389-001-03
11-Digit CMS (5-4-2)
71389-0001-03

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