Symbicort Aerosol
NDC 50090-4508

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 50090-4508?
  4. Symbicort Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes

Product Information

Symbicort (budesonide and formoterol fumarate dihydrate) is a NDA-approved product labeled by A-s Medication Solutions. This product is used to control and prevent symptoms (wheezing and shortness of breath) caused by asthma or ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchitis and emphysema). It is supplied as a aerosol for respiratory (inhalation) administration. This product entry covers the primary NDC 50090-4508 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
50090-4508
Proprietary Name:
Symbicort
Non-Proprietary Name: [1]
Budesonide And Formoterol Fumarate Dihydrate
Substance Name: [2]
Budesonide; Formoterol Fumarate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Aerosol - A product that is packaged under pressure and contains therapeutically active ingredients that are released upon activation of an appropriate valve system; it is intended for topical application to the skin as well as local application into the nose (nasal aerosols), mouth (lingual aerosols), or lungs (inhalation aerosols).
Administration Route(s): [4]
Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.

Labeler & Regulatory Data

Labeler Name: [5]
A-s Medication Solutions
Labeler Code:
50090
Product Label ID:
5feb8f35-b237-477a-9836-2a6db2ed6fa7
FDA Application Number: [6]
NDA021929
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
05-29-2007
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 50090-4508?

The NDC code 50090-4508 is assigned by the FDA to the product Symbicort. It is commonly known by its generic name, budesonide and formoterol fumarate dihydrate. This pharmaceutical product is labeled by A-s Medication Solutions and is currently categorized as listed product. The medication is a aerosol administered via respiratory (inhalation) route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 50090-4508-0. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

This product is used to control and prevent symptoms (wheezing and shortness of breath) caused by asthma or ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchitis and emphysema). It contains 2 medications: budesonide and formoterol. Budesonide belongs to a class of drugs known as corticosteroids. It works by reducing the irritation and swelling of the airways. Formoterol belongs to the class of drugs known as long-acting beta agonists. It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. Controlling symptoms of breathing problems can decrease time lost from work or school. When used alone, long-acting beta agonists (such as formoterol) may rarely increase the risk of serious (sometimes fatal) asthma-related breathing problems. However, combination inhaled corticosteroid and long-acting beta agonists, such as this product, do not increase the risk of serious asthma-related breathing problems. For asthma treatment, this product should be used when breathing problems are not well controlled with one asthma-control medication (such as inhaled corticosteroid) or if your symptoms need combination treatment. Before using this medication, it is important to learn how to use it properly. 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.

What are Active Ingredients of this product?

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 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 the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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 this product?

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: 1246304 - budesonide/formoterol fumarate 160/4.5 MCG/INHAL Metered Dose Inhaler, 120 Actuations
  • RxCUI: 1246304 - 120 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler
  • RxCUI: 1246304 - budesonide 0.16 MG / formoterol fumarate 0.0045 MG per ACTUAT Metered Dose Inhaler, 120 ACTUAT
  • RxCUI: 1246304 - budesonide 160 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 120 ACTUAT
  • RxCUI: 1246306 - Symbicort 160/4.5 MCG/INHAL Metered Dose Inhaler, 120 Actuations

Which are the Pharmacologic Classes of this product?

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.

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Product & Regulatory Definitions
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.
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".