Xopenex
NDC Package 54868-6021-0

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.

Xopenex is levalbuterol is used to treat wheezing and shortness of breath that commonly occur with lung problems (such as asthma, chronic obstructive pulmonary disease). Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-6021 and is authorized under FDA application NDA020837.

Identification & Billing

NDC Package Code
54868-6021-0
Package Description
30 POUCH in 1 CARTON / 1 VIAL in 1 POUCH / .5 mL in 1 VIAL
Product Code
54868-6021
11-Digit Billing Format
54868602100
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • RxCUI: 1855389 - levalbuterol HCl concentrate 1.25 MG in 0.5 ML Inhalation Solution
  • RxCUI: 1855389 - levalbuterol 2.5 MG/ML Inhalation Solution
  • RxCUI: 1855389 - levalbuterol HCl 1.25 MG per 0.5 ML Inhalation Solution
  • RxCUI: 1855391 - Xopenex Concentrate 1.25 MG in 0.5 ML Inhalation Solution
  • RxCUI: 1855391 - levalbuterol 2.5 MG/ML Inhalation Solution [Xopenex]

Clinical Specifications

Proprietary Name
Xopenex
Dosage Form
-
Usage Information
Levalbuterol is used to treat wheezing and shortness of breath that commonly occur with lung problems (such as asthma, chronic obstructive pulmonary disease). It is a quick-relief drug. Controlling these symptoms can decrease time lost from work or school. Levalbuterol belongs to a class of drugs known as bronchodilators. It works by relaxing the muscles around the airways so that they open up and you can breathe more easily.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
NDA020837
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-21-2009
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 54868-6021-0 identifies a specific commercial package of 30 pouch in 1 carton / 1 vial in 1 pouch / .5 ml in 1 vial of Xopenex, labeled by Physicians Total Care, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. 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 Physicians Total Care, Inc. on April 21, 2009. The current certification is valid through December 31, 2017.

What are the primary indications for this medication?

Levalbuterol is used to treat wheezing and shortness of breath that commonly occur with lung problems (such as asthma, chronic obstructive pulmonary disease). It is a quick-relief drug. Controlling these symptoms can decrease time lost from work or school. Levalbuterol belongs to a class of drugs known as bronchodilators. It works by relaxing the muscles around the airways so that they open up and you can breathe more easily.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868602100. 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 (5-4-1)
54868-6021-0
11-Digit CMS (5-4-2)
54868-6021-00

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