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  5. NDC Package Code: 78206-173-01 Singulair

NDC Package 78206-173-01 Singulair

Montelukast Sodium Tablet, Chewable Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

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:
78206-173-01
Package Description:
30 TABLET, CHEWABLE in 1 BOTTLE
Product Code:
78206-173
Proprietary Name:
Singulair
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:
78206017301
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
30 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 153892 - Singulair 10 MG Oral Tablet
  • RxCUI: 153892 - montelukast 10 MG Oral Tablet [Singulair]
  • RxCUI: 153892 - Singulair 10 MG (montelukast sodium 10.4 MG) Oral Tablet
  • RxCUI: 153893 - Singulair 5 MG Chewable Tablet
  • RxCUI: 153893 - montelukast 5 MG Chewable Tablet [Singulair]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Organon Llc
    Dosage Form:
    Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • MONTELUKAST SODIUM 5 mg/1
    • Pharmacologic Class(es):
  • Leukotriene Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • Leukotriene Receptor Antagonists - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA020830
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    06-01-2021
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    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 78206-173-01?

    The NDC Packaged Code 78206-173-01 is assigned to a package of 30 tablet, chewable in 1 bottle of Singulair, a human prescription drug labeled by Organon Llc. The product's dosage form is tablet, chewable and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package.

    Is NDC 78206-173 included in the NDC Directory?

    Yes, Singulair with product code 78206-173 is active and included in the NDC Directory. The product was first marketed by Organon Llc on June 01, 2021 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 NDC billing unit for package 78206-173-01?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 30.

    What is the 11-digit format for NDC 78206-173-01?

    The 11-digit format is 78206017301. 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
    5-3-278206-173-015-4-278206-0173-01