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  5. NDC Package Code: 0378-7502-32 Breyna

NDC Package 0378-7502-32 Breyna

Budesonide And Formoterol Fumarate Aerosol, Metered Respiratory (inhalation) - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

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
Proprietary Name:
Breyna
Non-Proprietary Name:
Budesonide And Formoterol Fumarate
Substance Name:
Budesonide; Formoterol Fumarate
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.
11-Digit NDC Billing Format:
00378750232
Billing Unit:
GM - Billing unit of "gram" is used when a product is measured by its weight.
NDC to 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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Mylan Pharmaceuticals Inc.
    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(s):
  • Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
    • Active Ingredient(s):
  • BUDESONIDE 80 ug/1
  • FORMOTEROL FUMARATE 4.5 ug/1
    • Pharmacologic Class(es):
  • Adrenergic beta2-Agonists - [MoA] (Mechanism of Action)
  • Corticosteroid Hormone Receptor Agonists - [MoA] (Mechanism of Action)
  • Corticosteroid - [EPC] (Established Pharmacologic Class)
  • beta2-Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA211699
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    07-31-2023
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 0378-7502-32?

    The NDC Packaged Code 0378-7502-32 is assigned to a 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.. The product's dosage form is aerosol, metered and is administered via respiratory (inhalation) form.

    Is NDC 0378-7502 included in the NDC Directory?

    Yes, Breyna with product code 0378-7502 is active and included in the NDC Directory. The product was first marketed by Mylan Pharmaceuticals Inc. on July 31, 2023 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0378-7502-32?

    The contents of this package are billed per "gm or gram", products billed per gram are products measured by weight.

    What is the 11-digit format for NDC 0378-7502-32?

    The 11-digit format is 00378750232. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20378-7502-325-4-200378-7502-32