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  4. NDC Product Code: 54868-5689 Xopenex Hfa

NDC 54868-5689 Xopenex Hfa

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 54868-5689?
  4. Xopenex Hfa Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
54868-5689
Proprietary Name:
Xopenex Hfa
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Physicians Total Care, Inc.
Labeler Code:
54868
Product Label ID:
320fea02-8aa3-44c8-b52a-a118418d1f78
Start Marketing Date: [9]
10-01-2007
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Navigator:

Code Structure Chart

Product Details

What is NDC 54868-5689?

The NDC code 54868-5689 is assigned by the FDA to the product Xopenex Hfa which is product labeled by Physicians Total Care, Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 54868-5689-0 200 aerosol, metered in 1 inhaler . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Xopenex Hfa?

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.

Which are Xopenex Hfa UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Xopenex Hfa Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Xopenex Hfa?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • 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

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Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".