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  4. NDC Product Code: 0310-4616 Breztri

NDC 0310-4616 Breztri

Budesonide,Glycopyrrolate,And Formoterol Fumarate Aerosol, Metered Respiratory - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 0310-4616?
  4. Breztri 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:
0310-4616
Proprietary Name:
Breztri
Non-Proprietary Name: [1]
Budesonide, Glycopyrrolate, And Formoterol Fumarate
Substance Name: [2]
Budesonide; Formoterol; Glycopyrrolate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Aerosol, Metered - A pressurized dosage form consisting of metered dose valves which allow for the delivery of a uniform quantity of spray upon each activation.
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:
    0310
    Product Label ID:
    715433dc-cb2b-43ea-b6df-c5b4177adc6c
    FDA Application Number: [6]
    NDA212122
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    07-23-2020
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 0310-4616-12

    Package Description: 120 AEROSOL, METERED in 1 INHALER

    Price per Unit: $57.81841 per GM

    NDC Code 0310-4616-28

    Package Description: 28 AEROSOL, METERED in 1 INHALER

    NDC Code 0310-4616-39

    Package Description: 28 AEROSOL, METERED in 1 INHALER

    Price per Unit: $58.12660 per GM

    Product Details

    What is NDC 0310-4616?

    The NDC code 0310-4616 is assigned by the FDA to the product Breztri which is a human prescription drug product labeled by Astrazeneca Pharmaceuticals Lp. The generic name of Breztri is budesonide, glycopyrrolate, and formoterol fumarate. The product's dosage form is aerosol, metered and is administered via respiratory (inhalation) form. The product is distributed in 3 packages with assigned NDC codes 0310-4616-12 120 aerosol, metered in 1 inhaler , 0310-4616-28 28 aerosol, metered in 1 inhaler , 0310-4616-39 28 aerosol, metered 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 Breztri?

    BREZTRI AEROSPHERE is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Limitations of Use: BREZTRI AEROSPHERE is not indicated for the relief of acute bronchospasm or for the treatment of asthma [see Warnings and Precautions (5.1, 5.2)].

    What are Breztri 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 160 ug/1 - A glucocorticoid used in the management of ASTHMA, the treatment of various skin disorders, and allergic RHINITIS.
    • FORMOTEROL 4.8 ug/1 - An ADRENERGIC BETA-2 RECEPTOR AGONIST with a prolonged duration of action. It is used to manage ASTHMA and in the treatment of CHRONIC OBSTRUCTIVE PULMONARY DISEASE.
    • GLYCOPYRROLATE 9 ug/1 - A muscarinic antagonist used as an antispasmodic, in some disorders of the gastrointestinal tract, and to reduce salivation with some anesthetics.

    Which are Breztri UNII Codes?

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

    Which are Breztri 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 Breztri?

    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: 2387326 - budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT 28 ACTUAT Metered Dose Inhaler
    • RxCUI: 2387326 - 28 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT Metered Dose Inhaler
    • RxCUI: 2387328 - BREZTRI 160/4.8/9 MCG/INHAL Metered Dose Inhaler, 28 Actuations
    • RxCUI: 2387328 - 28 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT Metered Dose Inhaler [Breztri]
    • RxCUI: 2387328 - BREZTRI (budesonide 160 MCG/ACTUAT / formoterol fumarate 4.8 MCG/ACTUAT / glycopyrrolate 9 MCG/ACTUAT) Metered Dose Inhaler, 28 ACTUAT

    Which are the Pharmacologic Classes for Breztri?

    * 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]


    Formoterol Oral Inhalation


    Formoterol oral inhalation is used to control wheezing, shortness of breath, and chest tightness caused by chronic obstructive pulmonary disease (COPD; a group of lung diseases that includes chronic bronchitis and emphysema). Formoterol is in a class of medications called long-acting beta agonists (LABAs). It works by relaxing and opening air passages in the lungs, making it easier to breathe.
    [Learn More]


    Glycopyrrolate Oral Inhalation


    Glycopyrrolate oral inhalation is used as a long term treatment to control wheezing, shortness of breath, coughing, and chest tightness in patients with chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways, that includes chronic bronchitis and emphysema). Glycopyrrolate is in a class of medications called anticholinergics. It works by relaxing the muscles around the airways in your 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".