Montelukast
NDC 0143-9649

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0143-9649?
  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.

Montelukast is a ANDA-approved product labeled by West Ward Pharmaceutical Corp. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a brown product. This product entry covers the primary NDC 0143-9649 and 3 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
0143-9649
Proprietary Name:
Montelukast
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
West Ward Pharmaceutical Corp
Labeler Code:
0143
Product Label ID:
43b80e54-bd48-46f0-835e-b055e797a8c0
FDA Application Number: [6]
ANDA202859
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
12-01-2014
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I

Product Characteristics

Color(s):
BROWN (C48332 - BEIGE)
Shape:
ROUND (C48348)
Size(s):
8 MM
Imprint(s):
AUM101
Score:
1

Code Structure Chart

Product Details

What is NDC 0143-9649?

The NDC code 0143-9649 is assigned by the FDA to the product Montelukast. This pharmaceutical product is labeled by West Ward Pharmaceutical Corp and is currently categorized as listed product. In terms of distribution, this product is available in 3 different package configurations. The associated package NDC(s) include: 0143-9649-09, 0143-9649-10, 0143-9649-30. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older.

Which are the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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 this product?

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 full disclaimer at the bottom of this page.

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.
[Learn More]


* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".