Qbrexza
NDC Package 70428-011-12

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 discontinued by the firm.

Qbrexza is this form of glycopyrronium is used to treat excessive sweating from your underarms. Marketed by Journey Medical Corporation, this product is identified by NDC 70428-011 and is authorized under FDA application NDA210361.

Identification & Billing

NDC Package Code
70428-011-12
Package Description
30 POUCH in 1 CARTON / 2.8 g in 1 POUCH (70428-011-11)
Product Code
70428-011
11-Digit Billing Format
70428001112
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Qbrexza
Dosage Form
-
Usage Information
This form of glycopyrronium is used to treat excessive sweating from your underarms. The drug solution is on a pre-moistened cloth for application to the skin. It works on the sweat glands to reduce sweating. Glycopyrronium belongs to a class of drugs known as anticholinergics.

Regulatory & Marketing

Labeler Name
Journey Medical Corporation
FDA Application #
NDA210361
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-28-2018
End Marketing Date
12-31-2022
Listing Expiration
12-31-2022
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 70428-011-12 identifies a specific commercial package of 30 pouch in 1 carton / 2.8 g in 1 pouch (70428-011-11) of Qbrexza, labeled by Journey Medical Corporation. 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 Journey Medical Corporation on June 28, 2018. The current certification is valid through December 31, 2022.

What are the primary indications for this medication?

This form of glycopyrronium is used to treat excessive sweating from your underarms. The drug solution is on a pre-moistened cloth for application to the skin. It works on the sweat glands to reduce sweating. Glycopyrronium belongs to a class of drugs known as anticholinergics.

How is this Journey Medical Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70428001112. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
70428-011-12
11-Digit CMS (5-4-2)
70428-0011-12

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