Burnzone
NDC Package 70338-621-12

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.

Burnzone is dults and children 2 years of age and over: Apply to affected area no more than 3 to 4 times daily. Marketed by Medzone Products Llc, this product is identified by NDC 70338-621 and is authorized under FDA application part348.

Identification & Billing

NDC Package Code
70338-621-12
Package Description
3.6 g in 1 POUCH
Product Code
70338-621
11-Digit Billing Format
70338062112
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Burnzone
Dosage Form
-
Usage Information
Dults and children 2 years of age and over: Apply to affected area no more than 3 to 4 times daily. Children under 2 years of age: consult a physician.

Regulatory & Marketing

Labeler Name
Medzone Products Llc
FDA Application #
part348
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
07-01-2016
Listing Expiration
12-31-2023
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 70338-621-12 identifies a specific commercial package of 3.6 g in 1 pouch of Burnzone, labeled by Medzone Products Llc. 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 Medzone Products Llc on July 01, 2016. The current certification is valid through December 31, 2023.

How is this Medzone Products Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70338062112. 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)
70338-621-12
11-Digit CMS (5-4-2)
70338-0621-12

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