Qbrexza Cloth
NDC Package 69489-411-05

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

Qbrexza (glycopyrronium) cloths is this form of glycopyrronium is used to treat excessive sweating from your underarms. This formulation utilizes a cloth delivery system. Marketed by Journey Medical Corporation, this product is identified by NDC 69489-411 and is authorized under FDA application NDA210361.

Identification & Billing

NDC Package Code
69489-411-05
Package Description
5 POUCH in 1 CARTON / 2.8 g in 1 POUCH (69489-411-51)
Product Code
69489-411
11-Digit Billing Format
69489041105
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Qbrexza
Non-Proprietary Name
Glycopyrronium
Substance Name
Glycopyrronium Tosylate
Dosage Form
Cloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
GLYCOPYRRONIUM TOSYLATE 2.4 g/100g
Pharmacologic Class
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
Product Type
Human Prescription Drug
FDA Application #
NDA210361
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-28-2018
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
Yes

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 (69489-411). Click a package code to view its specific billing and regulatory data.

69489-411-30
30 POUCH in 1 CARTON / 2.8 g in 1 POUCH (69489-411-01)

* 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 69489-411-05 identifies a specific commercial package of 5 pouch in 1 carton / 2.8 g in 1 pouch (69489-411-51) of Qbrexza, a human prescription drug labeled by Journey Medical Corporation. This cloth is formulated for topical use and contains glycopyrronium tosylate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Journey Medical Corporation on June 28, 2018. The current certification is valid through December 31, 2027.

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: 69489041105. 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)
69489-411-05
11-Digit CMS (5-4-2)
69489-0411-05

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