Breathiezzz
NDC Package 70359-4107-1

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.

Breathiezzz is see important warnings under " When using this product"Adults and children 2 years and over: roll layer on chest & throat or roll on sore aching muscles. Marketed by Fortunique B.v., this product is identified by NDC 70359-4107 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
70359-4107-1
Package Description
1 TUBE, WITH APPLICATOR in 1 CARTON / 10 g in 1 TUBE, WITH APPLICATOR
Product Code
70359-4107
11-Digit Billing Format
70359410701

Clinical Specifications

Proprietary Name
Breathiezzz
Dosage Form
-
Usage Information
See important warnings under " When using this product"Adults and children 2 years and over: roll layer on chest & throat or roll on sore aching muscles. Cover with a warm, dry cloth if desired. Keep clothing loose around throat /chest to help vapors reach the nose/mouth. Repeat up to three times per 24 hours or as directed by doctor. Children under 2 years: do not use

Regulatory & Marketing

Labeler Name
Fortunique B.v.
FDA Application #
part341
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
01-21-2016
Listing Expiration
12-31-2017
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 70359-4107-1 identifies a specific commercial package of 1 tube, with applicator in 1 carton / 10 g in 1 tube, with applicator of Breathiezzz, labeled by Fortunique B.v.. 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 Fortunique B.v. on January 21, 2016. The current certification is valid through December 31, 2017.

How is this Fortunique B.v. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70359410701. 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 (5-4-1)
70359-4107-1
11-Digit CMS (5-4-2)
70359-4107-01

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