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  5. NDC Package Code: 80426-041-01 Montelukast Sodium

NDC Package 80426-041-01 Montelukast Sodium

Granule - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

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:
80426-041-01
Package Description:
75 kg in 1 DRUM
Product Code:
80426-041
Non-Proprietary Name:
Montelukast Sodium
Substance Name:
Montelukast Sodium
Usage Information:
Montelukast is used to control and prevent symptoms caused by asthma (such as wheezing and shortness of breath). It is also used before exercise to prevent breathing problems during exercise (bronchospasm). This medication can help decrease the number of times you need to use your quick relief inhaler. Montelukast is also used to relieve symptoms of hay fever and allergic rhinitis (such as sneezing, stuffy/runny/itchy nose). Since there are other allergy medications that may be safer (see also Warning section), this medication should be used for this condition only when you cannot take other allergy medications or they do not work well. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden asthma attacks or breathing problems. If an asthma attack or sudden shortness of breath occurs, use your quick-relief inhaler as prescribed. This drug works by blocking certain natural substances (leukotrienes) that may cause or worsen asthma and allergies. It helps make breathing easier by reducing swelling (inflammation) in the airways.
11-Digit NDC Billing Format:
80426004101
Product Type:
Drug For Further Processing
Labeler Name:
Pel Healthcare Llc
Dosage Form:
Granule - A small particle or grain.
Active Ingredient(s):
  • MONTELUKAST SODIUM 1 kg/kg
    • Sample Package:
    N/A
    Marketing Category:
    DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
    Start Marketing Date:
    12-13-2017
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Unfinished Product:
    Yes
    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 80426-041-01?

    The NDC Packaged Code 80426-041-01 is assigned to an UNFINISHED drug package of 75 kg in 1 drum of Montelukast Sodium, drug for further processing labeled by Pel Healthcare Llc. The product's dosage form is granule and is administered via form.

    Is NDC 80426-041 included in the NDC Directory?

    Yes, Montelukast Sodium is an UNFINISHED PRODUCT with code 80426-041 that is active and included in the NDC Directory. The product was first marketed by Pel Healthcare Llc on December 13, 2017 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 80426-041-01?

    The 11-digit format is 80426004101. 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
    5-3-280426-041-015-4-280426-0041-01