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  5. NDC Package Code: 0173-0882-10 Breo Ellipta

NDC Package 0173-0882-10 Breo Ellipta

Fluticasone Furoate And Vilanterol Trifenatate Powder Respiratory (inhalation) - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
0173-0882-10
Package Description:
1 TRAY in 1 CARTON / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER
Product Code:
0173-0882
Proprietary Name:
Breo Ellipta
Non-Proprietary Name:
Fluticasone Furoate And Vilanterol Trifenatate
Substance Name:
Fluticasone Furoate; Vilanterol Trifenatate
Usage Information:
This medication is used to prevent and decrease symptoms (wheezing and trouble breathing) caused by asthma and ongoing lung disease (chronic obstructive pulmonary disease-COPD, including chronic bronchitis and emphysema). This inhaler contains 2 medications: fluticasone and vilanterol. Fluticasone belongs to a class of drugs known as corticosteroids. It works by reducing the swelling of the airways in the lungs to make breathing easier. Vilanterol belongs to a 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. When used alone, long-acting beta agonists (like vilanterol) 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.
11-Digit NDC Billing Format:
00173088210
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1424889 - fluticasone furoate/vilanterol 100/25 MCG/INHAL Dry Powder Inhaler, 30 Blisters
  • RxCUI: 1424889 - 30 ACTUAT fluticasone furoate 0.1 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler
  • RxCUI: 1424899 - fluticasone furoate/vilanterol 100/25 MCG/INHAL Dry Powder Inhaler, 14 Blisters
  • RxCUI: 1424899 - 14 ACTUAT fluticasone furoate 0.1 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler
  • RxCUI: 1539891 - Breo Ellipta 100/25 MCG/INHAL Dry Powder Inhaler, 14 Blisters
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Glaxosmithkline Llc
    Dosage Form:
    Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
    Administration Route(s):
  • Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
    • Active Ingredient(s):
  • FLUTICASONE FUROATE 200 ug/1
  • VILANTEROL TRIFENATATE 25 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:
    NDA204275
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    04-30-2015
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    0173-0882-141 TRAY in 1 CARTON / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER
    0173-0882-611 TRAY in 1 CARTON / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0173-0882-10?

    The NDC Packaged Code 0173-0882-10 is assigned to a package of 1 tray in 1 carton / 1 inhaler in 1 tray / 30 powder in 1 inhaler of Breo Ellipta, a human prescription drug labeled by Glaxosmithkline Llc. The product's dosage form is powder and is administered via respiratory (inhalation) form.

    Is NDC 0173-0882 included in the NDC Directory?

    Yes, Breo Ellipta with product code 0173-0882 is active and included in the NDC Directory. The product was first marketed by Glaxosmithkline Llc on April 30, 2015 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 0173-0882-10?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 0173-0882-10?

    The 11-digit format is 00173088210. 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
    4-4-20173-0882-105-4-200173-0882-10