Biotronix Healthcare
NDC Package 71389-101-01

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.

Biotronix Healthcare is uses For cleansing hands and arms prior to surgery. Marketed by Biotronix Healthcare Industries, Inc., this product is identified by NDC 71389-101 and is authorized under FDA application part333C.

Identification & Billing

NDC Package Code
71389-101-01
Package Description
20 mL in 1 POUCH
Product Code
71389-101
11-Digit Billing Format
71389010101

Clinical Specifications

Proprietary Name
Biotronix Healthcare
Dosage Form
-
Usage Information
Uses For cleansing hands and arms prior to surgery

Regulatory & Marketing

Labeler Name
Biotronix Healthcare Industries, Inc.
FDA Application #
part333C
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
05-03-2018
Listing Expiration
12-31-2019
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 71389-101-01 identifies a specific commercial package of 20 ml in 1 pouch of Biotronix Healthcare, 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 May 03, 2018. The current certification is valid through December 31, 2019.

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: 71389010101. 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)
71389-101-01
11-Digit CMS (5-4-2)
71389-0101-01

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