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  5. NDC Package Code: 59368-411-01 Xopenex Hfa

NDC Package 59368-411-01 Xopenex Hfa

View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing certification is expired.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
59368-411-01
Package Description:
1 INHALER in 1 CARTON / 200 AEROSOL, METERED in 1 INHALER
Product Code:
59368-411
Proprietary Name:
Xopenex Hfa
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.
11-Digit NDC Billing Format:
59368041101
NDC to 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
Labeler Name:
Praxis, Llc
Sample Package:
No
FDA Application Number:
NDA021730
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
11-10-2023
Listing Expiration Date:
12-31-2026
Exclude Flag:
E
Code Structure:

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 disclaimer below.

Frequently Asked Questions

What is NDC 59368-411-01?

The NDC Packaged Code 59368-411-01 is assigned to a package of 1 inhaler in 1 carton / 200 aerosol, metered in 1 inhaler of Xopenex Hfa, labeled by Praxis, Llc. The product's dosage form is and is administered via form.

Is NDC 59368-411 included in the NDC Directory?

No, Xopenex Hfa with product code 59368-411 is excluded from the NDC Directory for failure to respond to FDA's requests for correction to deficient or non-compliant submissions. The product was first marketed by Praxis, Llc on November 10, 2023 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 59368-411-01?

The 11-digit format is 59368041101. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-259368-411-015-4-259368-0411-01