Breztri Aerosol, Metered
NDC Package 0310-4616-28

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

Breztri (budesonide, glycopyrrolate, and formoterol fumarate) aerosols is bREZTRI AEROSPHERE is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). This formulation utilizes a aerosol, metered delivery system. Marketed by Astrazeneca Pharmaceuticals Lp, this product is identified by NDC 0310-4616 and is authorized under FDA application NDA212122.

Identification & Billing

NDC Package Code
0310-4616-28
Package Description
28 AEROSOL, METERED in 1 INHALER
Product Code
0310-4616
11-Digit Billing Format
00310461628
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
RxNorm Crosswalk
  • RxCUI: 2387326 - budesonide 0.16 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT / formoterol fumarate 0.0048 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: 2387326 - budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT 28 ACTUAT Metered Dose Inhaler
  • RxCUI: 2387328 - BREZTRI 160/9/4.8 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]

Clinical Specifications

Proprietary Name
Breztri
Non-Proprietary Name
Budesonide, Glycopyrrolate, And Formoterol Fumarate
Substance Name
Budesonide; Formoterol; 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
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)].

Regulatory & Marketing

Labeler Name
Astrazeneca Pharmaceuticals Lp
Product Type
Human Prescription Drug
FDA Application #
NDA212122
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-23-2020
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
Yes

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 (0310-4616). Click a package code to view its specific billing and regulatory data.

0310-4616-12
120 AEROSOL, METERED in 1 INHALER
0310-4616-39
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 0310-4616-28 identifies a specific commercial package of 28 aerosol, metered in 1 inhaler of Breztri, a human prescription drug labeled by Astrazeneca Pharmaceuticals Lp. This aerosol, metered is formulated for respiratory (inhalation) use and contains budesonide; formoterol; 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 July 23, 2020. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00310461628. 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 (4-4-2)
0310-4616-28
11-Digit CMS (5-4-2)
00310-4616-28

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