Bevespi Aerosphere Aerosol, Metered
NDC Package 0310-4600-28

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

Package Information

Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) aerosols is a medication used to control and prevent symptoms (such as wheezing and shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchitis and emphysema). This formulation utilizes a aerosol, metered delivery system. Marketed by Astrazeneca Pharmaceuticals Lp, this product is identified by NDC 0310-4600 and is authorized under FDA application NDA208294.

Identification & Billing

NDC Package Code
0310-4600-28
Package Description
28 AEROSOL, METERED in 1 INHALER
Product Code
0310-4600
11-Digit Billing Format
00310460028
RxNorm Crosswalk
  • RxCUI: 1790639 - glycopyrrolate/formoterol fumarate 9/4.8 MCG/INHAL Metered Dose Inhaler, 120 Actuations
  • RxCUI: 1790639 - 120 ACTUAT formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT Metered Dose Inhaler
  • RxCUI: 1790639 - formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT 120 ACTUAT Metered Dose Inhaler
  • RxCUI: 1790644 - BEVESPI Aerosphere 9/4.8 MCG/INHAL Metered Dose Inhaler, 120 Actuations
  • RxCUI: 1790644 - 120 ACTUAT formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT Metered Dose Inhaler [Bevespi]

Clinical Specifications

Proprietary Name
Bevespi Aerosphere
Non-Proprietary Name
Glycopyrrolate And Formoterol Fumarate
Substance Name
Formoterol Fumarate; Glycopyrrolate
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
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 (such as wheezing and shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchitis and emphysema). Controlling symptoms of breathing problems helps you maintain your normal activities and decreases time lost from work or school. This inhaler contains 2 medications: glycopyrrolate and formoterol. Both drugs work by relaxing the muscles around the airways so that they open up and you can breathe more easily. Glycopyrrolate belongs to a class of drugs known as anticholinergics. Formoterol belongs to the class of drugs known as long-acting beta agonists (LABAs). Both drugs are also known as bronchodilators. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden breathing problems. If sudden shortness of breath occurs, use your quick-relief inhaler as prescribed. Glycopyrrolate/formoterol is not approved to treat asthma. People with asthma using long-acting inhaled beta agonists (such as formoterol) without also using an inhaled corticosteroid may have an increased risk of serious (sometimes fatal) breathing problems.

Regulatory & Marketing

Labeler Name
Astrazeneca Pharmaceuticals Lp
Product Type
Human Prescription Drug
FDA Application #
NDA208294
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-03-2016
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0310-4600). Click a package code to view its specific billing and regulatory data.

0310-4600-12
120 AEROSOL, METERED in 1 INHALER
0310-4600-39
28 AEROSOL, METERED in 1 INHALER

* 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 0310-4600-28 identifies a specific commercial package of 28 aerosol, metered in 1 inhaler of Bevespi Aerosphere, a human prescription drug labeled by Astrazeneca Pharmaceuticals Lp. This aerosol, metered is formulated for respiratory (inhalation) use and contains formoterol fumarate; glycopyrrolate 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 Astrazeneca Pharmaceuticals Lp on October 03, 2016. 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 (such as wheezing and shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchitis and emphysema). Controlling symptoms of breathing problems helps you maintain your normal activities and decreases time lost from work or school. This inhaler contains 2 medications: glycopyrrolate and formoterol. Both drugs work by relaxing the muscles around the airways so that they open up and you can breathe more easily. Glycopyrrolate belongs to a class of drugs known as anticholinergics. Formoterol belongs to the class of drugs known as long-acting beta agonists (LABAs). Both drugs are also known as bronchodilators. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden breathing problems. If sudden shortness of breath occurs, use your quick-relief inhaler as prescribed. Glycopyrrolate/formoterol is not approved to treat asthma. People with asthma using long-acting inhaled beta agonists (such as formoterol) without also using an inhaled corticosteroid may have an increased risk of serious (sometimes fatal) breathing problems.

How is this Astrazeneca Pharmaceuticals Lp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00310460028. 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 (4-4-2)
0310-4600-28
11-Digit CMS (5-4-2)
00310-4600-28

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