Montelukast Sodium
NDC 68645-528
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
Montelukast Sodium is a ANDA-approved product labeled by Legacy Pharmaceutical Packaging, Llc. Montelukast is used to control and prevent symptoms caused by asthma (such as wheezing and shortness of breath). It is supplied as a product. This product entry covers the primary NDC 68645-528 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
68645-528
Proprietary Name:
Montelukast Sodium
Product Type: [3]
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
68645
FDA Application Number: [6]
ANDA078605
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
08-03-2012
End Marketing Date: [10]
11-30-2018
Listing Expiration Date: [11]
11-30-2018
Exclude Flag: [12]
D
Code Structure Chart
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 & 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 End Marketing Date? This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
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".
