NDC 0378-7502 Breyna
Budesonide And Formoterol Fumarate Aerosol, Metered Respiratory (inhalation) - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
Code Structure Chart
Product Details
What is NDC 0378-7502?
What are the uses for Breyna?
What are Breyna Active Ingredients?
- BUDESONIDE 80 ug/1 - A glucocorticoid used in the management of ASTHMA, the treatment of various skin disorders, and allergic RHINITIS.
- FORMOTEROL FUMARATE 4.5 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.
Which are Breyna UNII Codes?
The UNII codes for the active ingredients in this product are:
- BUDESONIDE (UNII: Q3OKS62Q6X)
- BUDESONIDE (UNII: Q3OKS62Q6X) (Active Moiety)
- FORMOTEROL FUMARATE (UNII: W34SHF8J2K)
- FORMOTEROL (UNII: 5ZZ84GCW8B) (Active Moiety)
Which are Breyna 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:
- POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
- POVIDONE K25 (UNII: K0KQV10C35)
- APAFLURANE (UNII: R40P36GDK6)
What is the NDC to RxNorm Crosswalk for Breyna?
- RxCUI: 1246288 - budesonide/formoterol fumarate 80/4.5 MCG/INHAL Metered Dose Inhaler, 120 Actuations
- RxCUI: 1246288 - 120 ACTUAT budesonide 0.08 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler
- RxCUI: 1246288 - budesonide 0.08 MG / formoterol fumarate 0.0045 MG per ACTUAT Metered Dose Inhaler, 120 ACTUAT
- RxCUI: 1246288 - budesonide 80 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 120 ACTUAT
- RxCUI: 1246304 - budesonide/formoterol fumarate 160/4.5 MCG/INHAL Metered Dose Inhaler, 120 Actuations
Which are the Pharmacologic Classes for Breyna?
* Please review the disclaimer below.
Patient Education
Budesonide and Formoterol Oral Inhalation
The combination of budesonide and formoterol is used to prevent and treat difficulty breathing, wheezing, shortness of breath, coughing, and chest tightness caused by asthma in adults and children 6 years of age and older. The combination of budesonide and formoterol is also used to treat chronic obstructive pulmonary (COPD; a group of diseases that affect the lungs and airways, that includes chronic bronchitis and emphysema) in adults. Budesonide is in a class of medications called steroids. It works by reducing swelling in the airways. 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.
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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.
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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.
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* Please review the disclaimer below.
[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".