Xopenex Hfa
NDC Package 54868-5689-0

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 Hfa is levalbuterol is used to prevent and treat wheezing and shortness of breath caused by breathing problems (such as asthma, chronic obstructive pulmonary disease). Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-5689 and is authorized under FDA application NDA021730.

Identification & Billing

NDC Package Code
54868-5689-0
Package Description
200 AEROSOL, METERED in 1 INHALER
Product Code
54868-5689
11-Digit Billing Format
54868568900
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
RxNorm Crosswalk
  • RxCUI: 745791 - levalbuterol 45 MCG/INHAL Metered Dose Inhaler, 200 Actuations
  • RxCUI: 745791 - 200 ACTUAT levalbuterol 0.045 MG/ACTUAT Metered Dose Inhaler
  • RxCUI: 745791 - levalbuterol 0.045 MG/ACTUAT Metered Dose Inhaler, 200 ACTUAT
  • RxCUI: 745791 - levalbuterol 45 MCG/ACTUAT Metered Dose Inhaler, 200 ACTUAT
  • RxCUI: 746466 - Xopenex HFA 45 MCG/INHAL Metered Dose Inhaler, 200 Actuations

Clinical Specifications

Proprietary Name
Xopenex Hfa
Dosage Form
-
Usage Information
Levalbuterol is used to prevent and treat wheezing and shortness of breath caused by breathing problems (such as asthma, chronic obstructive pulmonary disease). It is a quick-relief drug. 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. Controlling symptoms of breathing problems can decrease time lost from work or school. This drug is not approved for use in children younger than 4 years due to increased risk of side effects (such as unusual fast breathing, worsening asthma). Ask your doctor or pharmacist for details.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
NDA021730
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-01-2007
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 54868-5689-0 identifies a specific commercial package of 200 aerosol, metered in 1 inhaler of Xopenex Hfa, labeled by Physicians Total Care, Inc.. 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 October 01, 2007. The current certification is valid through December 31, 2017.

What are the primary indications for this medication?

Levalbuterol is used to prevent and treat wheezing and shortness of breath caused by breathing problems (such as asthma, chronic obstructive pulmonary disease). It is a quick-relief drug. 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. Controlling symptoms of breathing problems can decrease time lost from work or school. This drug is not approved for use in children younger than 4 years due to increased risk of side effects (such as unusual fast breathing, worsening asthma). Ask your doctor or pharmacist for details.

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: 54868568900. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. 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)
54868-5689-0
11-Digit CMS (5-4-2)
54868-5689-00

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