Breyna Aerosol, Metered
NDC Package 0378-7502-32

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

Package Information

Breyna (budesonide and formoterol fumarate) aerosols is the use of BREYNA is contraindicated in the following conditions:•Primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required.•Hypersensitivity to any of the ingredients in BREYNA. This formulation utilizes a aerosol, metered delivery system. Marketed by Mylan Pharmaceuticals Inc., this product is identified by NDC 0378-7502 and is authorized under FDA application ANDA211699.

Identification & Billing

NDC Package Code
0378-7502-32
Package Description
1 POUCH in 1 CARTON / 1 CANISTER in 1 POUCH / 120 AEROSOL, METERED in 1 CANISTER
Product Code
0378-7502
11-Digit Billing Format
00378750232
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
RxNorm Crosswalk
  • 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

Clinical Specifications

Proprietary Name
Breyna
Non-Proprietary Name
Budesonide And Formoterol Fumarate
Substance Name
Budesonide; Formoterol Fumarate
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
The use of BREYNA is contraindicated in the following conditions:•Primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required.•Hypersensitivity to any of the ingredients in BREYNA.

Regulatory & Marketing

Labeler Name
Mylan Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA211699
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-31-2023
Listing Expiration
12-31-2027
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 0378-7502-32 identifies a specific commercial package of 1 pouch in 1 carton / 1 canister in 1 pouch / 120 aerosol, metered in 1 canister of Breyna, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. This aerosol, metered 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 Mylan Pharmaceuticals Inc. on July 31, 2023. The current certification is valid through December 31, 2027.

How is this Mylan Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00378750232. 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)
0378-7502-32
11-Digit CMS (5-4-2)
00378-7502-32

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