NDC 0143-9650 Montelukast
View Dosage, Usage, Ingredients, Routes, UNII
Product Information
Get all the details for National Drug Code (NDC) 0143-9650 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.
Product Characteristics
PINK (C48328 - PINK)
OVAL (C48345)
11 MM
10 MM
AUM103
AUM102
Code Structure Chart
Product Details
What is NDC 0143-9650?
What are the uses for Montelukast?
Which are Montelukast UNII Codes?
The UNII codes for the active ingredients in this product are:
- MONTELUKAST SODIUM (UNII: U1O3J18SFL)
- MONTELUKAST (UNII: MHM278SD3E) (Active Moiety)
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:
- CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
- LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
- CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
- HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- HYPROMELLOSES (UNII: 3NXW29V3WO)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
- FERRIC OXIDE RED (UNII: 1K09F3G675)
- FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
- CARNAUBA WAX (UNII: R12CBM0EIZ)
- MANNITOL (UNII: 3OWL53L36A)
- CHERRY (UNII: BUC5I9595W)
- ASPARTAME (UNII: Z0H242BBR1)
What is the NDC to RxNorm Crosswalk for Montelukast?
- RxCUI: 200224 - montelukast sodium 10 MG Oral Tablet
- RxCUI: 200224 - montelukast 10 MG Oral Tablet
- RxCUI: 200224 - montelukast 10 MG (as montelukast sodium 10.4 MG) Oral Tablet
- RxCUI: 242438 - montelukast sodium 5 MG Chewable Tablet
- RxCUI: 242438 - montelukast 5 MG Chewable Tablet
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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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[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.
[6] 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.
[8] 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.
[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, 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".