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NDC 0186-0916 Pulmicort Flexhaler

Budesonide Aerosol, Powder Respiratory (inhalation) - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 0186-0916?
  4. Pulmicort Flexhaler 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:
0186-0916
Proprietary Name:
Pulmicort Flexhaler
Non-Proprietary Name: [1]
Budesonide
Substance Name: [2]
Budesonide
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]
  • Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
    • Labeler Name: [5]
    Astrazeneca Pharmaceuticals Lp
    Labeler Code:
    0186
    Product Label ID:
    54234b7d-3bcc-4809-1881-1d21484856a0
    FDA Application Number: [6]
    NDA021949
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    03-19-2007
    End Marketing Date: [10]
    10-31-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 0186-0916-12

    Package Description: 1 INHALER in 1 CARTON / 120 AEROSOL, POWDER in 1 INHALER

    Price per Unit: $253.87127 per EA

    Product Details

    What is NDC 0186-0916?

    The NDC code 0186-0916 is assigned by the FDA to the product Pulmicort Flexhaler which is a human prescription drug product labeled by Astrazeneca Pharmaceuticals Lp. The generic name of Pulmicort Flexhaler is budesonide. The product's dosage form is aerosol, powder and is administered via respiratory (inhalation) form. The product is distributed in a single package with assigned NDC code 0186-0916-12 1 inhaler in 1 carton / 120 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 Pulmicort Flexhaler?

    Budesonide is used to control and prevent symptoms (wheezing and shortness of breath) caused by asthma. This medication belongs to a class of drugs known as corticosteroids. It works directly in the lungs to make breathing easier by reducing the irritation and swelling of the airways. 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 as prescribed.

    What are Pulmicort Flexhaler 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.
    • BUDESONIDE 180 ug/1 - A glucocorticoid used in the management of ASTHMA, the treatment of various skin disorders, and allergic RHINITIS.

    Which are Pulmicort Flexhaler UNII Codes?

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

    Which are Pulmicort Flexhaler 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 Pulmicort Flexhaler?

    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: 966522 - budesonide 180 MCG/INHAL Dry Powder Inhaler, 120 ACTUAT
    • RxCUI: 966522 - 120 ACTUAT budesonide 0.18 MG/ACTUAT Dry Powder Inhaler
    • RxCUI: 966522 - budesonide 0.18 MG/ACTUAT (0.16 MG/ACTUAT from the mouthpiece) Dry Powder Inhaler, 120 ACTUAT
    • RxCUI: 966522 - budesonide 180 MCG/ACTUAT Dry Powder Inhaler, 120 ACTUATS
    • RxCUI: 966524 - Pulmicort Flexhaler 180 MCG/INHAL Dry Powder Inhaler, 120 ACTUAT

    Which are the Pharmacologic Classes for Pulmicort Flexhaler?

    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

    Budesonide Oral Inhalation


    Budesonide is used to prevent difficulty breathing, chest tightness, wheezing, and coughing caused by asthma. Budesonide powder for oral inhalation (Pulmicort Flexhaler) is used in adults and children 6 years of age and older. Budesonide suspension (liquid) for oral inhalation (Pulmicort Respules) is used in children 12 months to 8 years of age. Budesonide belongs to a class of medications called corticosteroids. It works by decreasing swelling and irritation in the airways to allow for easier breathing.
    [Learn More]


    Steroids


    You may have heard of anabolic steroids, which can have harmful effects. But there's another type of steroid - sometimes called a corticosteroid - that treats a variety of problems. These steroids are similar to hormones that your adrenal glands make to fight stress associated with illnesses and injuries. They reduce inflammation and affect the immune system.

    You may need to take corticosteroids to treat:

    • Arthritis
    • Asthma
    • Autoimmune diseases such as lupus and multiple sclerosis
    • Skin conditions such as eczema and rashes
    • Some kinds of cancer

    Steroids are strong medicines, and they can have side effects, including weakened bones and cataracts. Because of this, you usually take them for as short a time as possible.


    [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.

    [10] 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.

    [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".