NDC 63629-8106 Montelukast Sodium

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
63629-8106
Proprietary Name:
Montelukast Sodium
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Bryant Ranch Prepack
Labeler Code:
63629
Start Marketing Date: [9]
04-11-2013
Listing Expiration Date: [11]
12-31-2023
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
BROWN (C48332 - BEIGE)
Shape:
SQUARE (C48350)
Size(s):
8 MM
Imprint(s):
M10
Score:
1

Product Packages

NDC Code 63629-8106-1

Package Description: 30 TABLET, FILM COATED in 1 BOTTLE

NDC Code 63629-8106-2

Package Description: 90 TABLET, FILM COATED in 1 BOTTLE

Product Details

What is NDC 63629-8106?

The NDC code 63629-8106 is assigned by the FDA to the product Montelukast Sodium which is product labeled by Bryant Ranch Prepack. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 63629-8106-1 30 tablet, film coated in 1 bottle , 63629-8106-2 90 tablet, film coated in 1 bottle . 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 Montelukast Sodium?

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.

Which are Montelukast Sodium UNII Codes?

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

Which are Montelukast Sodium 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 Montelukast Sodium?

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:

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Patient Education

Montelukast


Montelukast is used to prevent wheezing, difficulty breathing, chest tightness, and coughing caused by asthma in adults and children 12 months of age and older. Montelukast is also used to prevent bronchospasm (breathing difficulties) during exercise in adults and children 6 years of age and older. Montelukast is also used to treat the symptoms of seasonal (occurs only at certain times of the year), allergic rhinitis (a condition associated with sneezing and stuffy, runny or itchy nose) in adults and children 2 years of age and older, and perennial (occurs all year round) allergic rhinitis in adults and children 6 months of age and older. Montelukast should be used to treat seasonal or perennial allergic rhinitis only in adults and children who cannot be treated with other medications. Montelukast is in a class of medications called leukotriene receptor antagonists (LTRAs). It works by blocking the action of substances in the body that cause the symptoms of asthma and allergic rhinitis.
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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".