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  4. NDC Product Code: 0173-0873 Incruse Ellipta

NDC 0173-0873 Incruse Ellipta

Umeclidinium Aerosol, Powder Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 0173-0873?
  4. Incruse Ellipta Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes
  10. Patient Education

Product Information

NDC Product Code:
0173-0873
Proprietary Name:
Incruse Ellipta
Non-Proprietary Name: [1]
Umeclidinium
Substance Name: [2]
Umeclidinium Bromide
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Aerosol, Powder - A product that is packaged under pressure and contains therapeutically active ingredients, in the form of a powder, that are released upon activation of an appropriate valve system.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Glaxosmithkline Llc
    Labeler Code:
    0173
    Product Label ID:
    dbb64747-1505-49d7-9a33-99dd402e96d3
    FDA Application Number: [6]
    NDA205382
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    04-30-2014
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 0173-0873-06

    Package Description: 1 TRAY in 1 CARTON / 1 INHALER in 1 TRAY / 7 AEROSOL, POWDER in 1 INHALER

    Price per Unit: $10.26590 per EA

    NDC Code 0173-0873-10

    Package Description: 1 TRAY in 1 CARTON / 1 INHALER in 1 TRAY / 30 AEROSOL, POWDER in 1 INHALER

    Price per Unit: $11.32920 per EA

    Product Details

    What is NDC 0173-0873?

    The NDC code 0173-0873 is assigned by the FDA to the product Incruse Ellipta which is a human prescription drug product labeled by Glaxosmithkline Llc. The generic name of Incruse Ellipta is umeclidinium. The product's dosage form is aerosol, powder and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 0173-0873-06 1 tray in 1 carton / 1 inhaler in 1 tray / 7 aerosol, powder in 1 inhaler, 0173-0873-10 1 tray in 1 carton / 1 inhaler in 1 tray / 30 aerosol, powder 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 Incruse Ellipta?

    Umeclidinium is used to control and prevent symptoms (such as wheezing, shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes bronchitis and emphysema). It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. Umeclidinium belongs to a class of drugs known as anticholinergics. Controlling symptoms of breathing problems can decrease time lost from work or school. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden shortness of breath. If wheezing or sudden shortness of breath occurs, use your quick-relief inhaler (such as albuterol, also called salbutamol in some countries) as prescribed.

    What are Incruse Ellipta 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.

    Which are Incruse Ellipta UNII Codes?

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

    Which are Incruse Ellipta 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 Incruse Ellipta?

    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: 1539251 - umeclidinium 62.5 MCG/INHAL Dry Powder Inhaler, 30 Blisters
    • RxCUI: 1539251 - 30 ACTUAT umeclidinium 0.0625 MG/ACTUAT Dry Powder Inhaler
    • RxCUI: 1539885 - Incruse Ellipta 62.5 MCG/INHAL Dry Powder Inhaler, 30 Blisters
    • RxCUI: 1539885 - 30 ACTUAT umeclidinium 0.0625 MG/ACTUAT Dry Powder Inhaler [Incruse]
    • RxCUI: 1539885 - Incruse Ellipta (umeclidinium 62.5 MCG) per ACTUAT Dry Powder Inhaler, 30 ACTUAT

    Which are the Pharmacologic Classes for Incruse Ellipta?

    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

    Umeclidinium Oral Inhalation


    Umeclidinium oral inhalation is used in adults to control wheezing, shortness of breath, coughing, and chest tightness caused by chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways, that includes chronic bronchitis and emphysema). Umeclidinium inhalation is in a class of medications called anticholinergics. It works by relaxing and opening air passages in the lungs, making it easier to breathe.
    [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".