Symbicort Aerosol
NDC Package 50090-4510-0

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Symbicort (budesonide and formoterol fumarate dihydrate) aerosols is a medication 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). This formulation utilizes a aerosol delivery system. Marketed by A-s Medication Solutions, this product is identified by NDC 50090-4510 and is authorized under FDA application NDA021929.

Identification & Billing

NDC Package Code
50090-4510-0
Package Description
1 POUCH in 1 CARTON / 1 AEROSOL in 1 POUCH
Product Code
50090-4510
11-Digit Billing Format
50090451000
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
RxNorm Crosswalk
  • RxCUI: 1246314 - budesonide/formoterol fumarate 80/4.5 MCG/INHAL Metered Dose Inhaler, 60 Actuations
  • RxCUI: 1246314 - 60 ACTUAT budesonide 0.08 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler
  • RxCUI: 1246314 - budesonide 0.08 MG / formoterol fumarate 0.0045 MG per ACTUAT Metered Dose Inhaler, 60 ACTUAT
  • RxCUI: 1246314 - budesonide 80 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 60 ACTUAT
  • RxCUI: 1246315 - Symbicort 80/4.5 MCG/INHAL Metered Dose Inhaler, 60 Actuations

Clinical Specifications

Proprietary Name
Symbicort
Non-Proprietary Name
Budesonide And Formoterol Fumarate Dihydrate
Substance Name
Budesonide; Formoterol Fumarate
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
Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
Active Ingredient(s)
Pharmacologic Class
Usage Information
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.

Regulatory & Marketing

Labeler Name
A-s Medication Solutions
Product Type
Human Prescription Drug
FDA Application #
NDA021929
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-29-2007
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 50090-4510-0 identifies a specific commercial package of 1 pouch in 1 carton / 1 aerosol in 1 pouch of Symbicort, a human prescription drug labeled by A-s Medication Solutions. This aerosol is formulated for respiratory (inhalation) use and contains budesonide; formoterol fumarate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by A-s Medication Solutions on May 29, 2007. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this A-s Medication Solutions product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50090451000. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
50090-4510-0
11-Digit CMS (5-4-2)
50090-4510-00

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.