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  4. NDC Product Code: 63629-4886 Montelukast

NDC 63629-4886 Montelukast

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 63629-4886?
  5. Montelukast Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
63629-4886
Proprietary Name:
Montelukast
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Bryant Ranch Prepack
Labeler Code:
63629
Product Label ID:
e67c211a-cee7-41e8-9a2a-32d7363ef2a3
Start Marketing Date: [9]
08-03-2012
Listing Expiration Date: [11]
12-31-2023
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
BROWN (C48332 - BEIGE)
Shape:
ROUND (C48348)
Size(s):
8 MM
Imprint(s):
SZ;344
Score:
1

Code Structure Chart

Product Details

What is NDC 63629-4886?

The NDC code 63629-4886 is assigned by the FDA to the product Montelukast which is product labeled by Bryant Ranch Prepack. The product's dosage form is . The product is distributed in 8 packages with assigned NDC codes 63629-4886-1 30 tablet, film coated in 1 bottle , 63629-4886-2 4 tablet, film coated in 1 bottle , 63629-4886-3 7 tablet, film coated in 1 bottle , 63629-4886-4 60 tablet, film coated in 1 bottle , 63629-4886-5 10 tablet, film coated in 1 bottle , 63629-4886-6 90 tablet, film coated in 1 bottle , 63629-4886-7 120 tablet, film coated in 1 bottle , 63629-4886-8 15 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?

Hypersensitivity to any component of this product.

Which are Montelukast UNII Codes?

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

Which are Montelukast 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?

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:

* Please review the disclaimer below.

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".