NDC 78206-115 Asmanex

Mometasone Furoate Inhalant Respiratory (inhalation) - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
78206-115
Proprietary Name:
Asmanex
Non-Proprietary Name: [1]
Mometasone Furoate
Substance Name: [2]
Mometasone Furoate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Inhalant - A special class of inhalations consisting of a drug or combination of drugs, that by virtue of their high vapor pressure can be carried by an air current into the nasal passage where they exert their effect; the container from which the inhalant generally is administered is known as an inhaler.
Administration Route(s): [4]
  • Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
  • Labeler Name: [5]
    Organon Llc
    Labeler Code:
    78206
    FDA Application Number: [6]
    NDA021067
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    06-01-2021
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 78206-115-01

    Package Description: 1 POUCH in 1 CARTON / 1 INHALER in 1 POUCH / 30 INHALANT in 1 INHALER

    Price per Unit: $89.32400 per EA

    NDC Code 78206-115-59

    Package Description: 1 POUCH in 1 CARTON / 1 INHALER in 1 POUCH / 7 INHALANT in 1 INHALER

    Product Details

    What is NDC 78206-115?

    The NDC code 78206-115 is assigned by the FDA to the product Asmanex which is a human prescription drug product labeled by Organon Llc. The generic name of Asmanex is mometasone furoate. The product's dosage form is inhalant and is administered via respiratory (inhalation) form. The product is distributed in 2 packages with assigned NDC codes 78206-115-01 1 pouch in 1 carton / 1 inhaler in 1 pouch / 30 inhalant in 1 inhaler, 78206-115-59 1 pouch in 1 carton / 1 inhaler in 1 pouch / 7 inhalant in 1 inhaler. 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 Asmanex?

    Mometasone is used to control and prevent symptoms (wheezing and shortness of breath) caused by asthma. 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. If an asthma attack occurs, use your quick-relief inhaler (such as albuterol, also called salbutamol in some countries) as prescribed. Mometasone belongs to a class of drugs known as corticosteroids. It works by reducing the irritation and swelling of the airways. Controlling symptoms of breathing problems can decrease time lost from work or school.

    What are Asmanex Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
    • MOMETASONE FUROATE 110 ug/1 - A pregnadienediol derivative ANTI-ALLERGIC AGENT and ANTI-INFLAMMATORY AGENT that is used in the management of ASTHMA and ALLERGIC RHINITIS. It is also used as a topical treatment for skin disorders.

    Which are Asmanex UNII Codes?

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

    Which are Asmanex 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 Asmanex?

    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:
    • RxCUI: 746803 - mometasone furoate 220 MCG/INHAL Dry Powder Inhaler, 120 ACTUAT
    • RxCUI: 746803 - 120 ACTUAT mometasone furoate 0.22 MG/ACTUAT Dry Powder Inhaler
    • RxCUI: 746803 - mometasone furoate 0.22 MG/ACTUAT Dry Powder Inhaler, 120 ACTUAT
    • RxCUI: 746804 - Asmanex Twisthaler 220 MCG/INHAL Dry Powder Inhaler, 120 ACTUAT
    • RxCUI: 746804 - 120 ACTUAT mometasone furoate 0.22 MG/ACTUAT Dry Powder Inhaler [Asmanex]

    Which are the Pharmacologic Classes for Asmanex?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Patient Education

    Mometasone Oral Inhalation


    Mometasone oral inhalation is used to prevent difficulty breathing, chest tightness, wheezing, and coughing caused by asthma. Mometasone oral inhalation (Asmanex® HFA) is used in adults and children 12 years of age and older. Mometasone powder for oral inhalation (Asmanex® Twisthaler) is used in adults and children 4 years of age and older. It is in a class of medications called corticosteroids. Mometasone works by decreasing swelling and irritation in the airways to allow for easier breathing.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [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 ("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".