Breo Ellipta Powder
NDC Package 0173-0859-10

11-digit billing NDC: 00173085910 · Billing unit: EA · 30 EA per package
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Breo Ellipta (fluticasone furoate and vilanterol trifenatate) powders is bREO ELLIPTA is contraindicated in the following conditions:•Primary treatment of status asthmaticus or other acute episodes of COPD or asthma where intensive measures are required [see Warnings and Precautions (5.2)].•Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone furoate, vilanterol, or any of the excipients [see Warnings and Precautions (5.11), Description (11)]. This formulation utilizes a powder delivery system. Marketed by Glaxosmithkline Llc, this product is identified by NDC 0173-0859 and is authorized under FDA application NDA204275.

Identification & Billing

NDC Package Code
0173-0859-10
Package Description
1 TRAY in 1 CARTON / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER
Product Code
0173-0859
11-Digit Billing Format
00173085910
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
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

Clinical Specifications

Proprietary Name
Breo Ellipta
Non-Proprietary Name
Fluticasone Furoate And Vilanterol Trifenatate
Substance Name
Fluticasone Furoate; Vilanterol Trifenatate
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
Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
Active Ingredient(s)
Pharmacologic Class
Usage Information
BREO ELLIPTA is contraindicated in the following conditions:•Primary treatment of status asthmaticus or other acute episodes of COPD or asthma where intensive measures are required [see Warnings and Precautions (5.2)].•Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone furoate, vilanterol, or any of the excipients [see Warnings and Precautions (5.11), Description (11)].

Regulatory & Marketing

Labeler Name
Glaxosmithkline Llc
Product Type
Human Prescription Drug
FDA Application #
NDA204275
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-26-2013
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0173-0859). Click a package code to view its specific billing and regulatory data.

0173-0859-14
1 TRAY in 1 CARTON / 1 INHALER in 1 TRAY / 14 POWDER 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 0173-0859-10 identifies a specific commercial 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. This powder is formulated for respiratory (inhalation) use and contains fluticasone furoate; vilanterol trifenatate 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 Glaxosmithkline Llc on August 26, 2013. The current certification is valid through December 31, 2027.

How is this Glaxosmithkline Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00173085910. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. 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)
0173-0859-10
11-Digit CMS (5-4-2)
00173-0859-10

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