Anoro Ellipta Powder
NDC Package 0173-0869-61

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

Anoro Ellipta (umeclidinium bromide and vilanterol trifenatate) powders is a medication used to control and prevent symptoms (such as wheezing and shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchitis and emphysema). This formulation utilizes a powder delivery system. Marketed by Glaxosmithkline Llc, this product is identified by NDC 0173-0869 and is authorized under FDA application NDA203975.

Identification & Billing

NDC Package Code
0173-0869-61
Package Description
1 TRAY in 1 CARTON / 1 INHALER in 1 TRAY / 7 POWDER in 1 INHALER
Product Code
0173-0869
11-Digit Billing Format
00173086961
RxNorm Crosswalk
  • RxCUI: 1487519 - umeclidinium/vilanterol 62.5/25 MCG/INHAL Dry Powder Inhaler, 7 Blisters
  • RxCUI: 1487519 - 7 ACTUAT umeclidinium 0.0625 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler
  • RxCUI: 1487519 - umeclidinium 0.0625 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT 7 ACTUAT Dry Powder Inhaler
  • RxCUI: 1487524 - ANORO Ellipta 62.5/25 MCG/INHAL Dry Powder Inhaler, 7 Blisters
  • RxCUI: 1487524 - 7 ACTUAT umeclidinium 0.0625 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler [Anoro]

Clinical Specifications

Proprietary Name
Anoro Ellipta
Non-Proprietary Name
Umeclidinium Bromide And Vilanterol Trifenatate
Substance Name
Umeclidinium Bromide; 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
This product is used to control and prevent symptoms (such as wheezing and shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchitis and emphysema). Controlling symptoms of breathing problems helps you stay active. This inhaler contains 2 medications: umeclidinium and vilanterol. Both drugs work by relaxing the muscles around the airways so that they open up and you can breathe more easily. Umeclidinium belongs to a class of drugs known as anticholinergics. Vilanterol belongs to the class of drugs known as long-acting beta agonists (LABAs). Both drugs are also known as bronchodilators. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden shortness of breath. If sudden breathing problems occur, use your quick-relief inhaler as prescribed. Umeclidinium/vilanterol is not approved to treat asthma. People with asthma using long-acting inhaled beta agonists (such as vilanterol) without also using an inhaled corticosteroid may have an increased risk of serious (sometimes fatal) breathing problems.

Regulatory & Marketing

Labeler Name
Glaxosmithkline Llc
Product Type
Human Prescription Drug
FDA Application #
NDA203975
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-31-2014
Listing Expiration
12-31-2026
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 (0173-0869). Click a package code to view its specific billing and regulatory data.

0173-0869-06
1 TRAY in 1 CARTON / 1 INHALER in 1 TRAY / 7 POWDER in 1 INHALER
0173-0869-10
1 TRAY in 1 CARTON / 1 INHALER in 1 TRAY / 30 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 0173-0869-61 identifies a specific commercial package of 1 tray in 1 carton / 1 inhaler in 1 tray / 7 powder in 1 inhaler of Anoro Ellipta, a human prescription drug labeled by Glaxosmithkline Llc. This powder is formulated for respiratory (inhalation) use and contains umeclidinium bromide; 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 January 31, 2014. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This product is used to control and prevent symptoms (such as wheezing and shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchitis and emphysema). Controlling symptoms of breathing problems helps you stay active. This inhaler contains 2 medications: umeclidinium and vilanterol. Both drugs work by relaxing the muscles around the airways so that they open up and you can breathe more easily. Umeclidinium belongs to a class of drugs known as anticholinergics. Vilanterol belongs to the class of drugs known as long-acting beta agonists (LABAs). Both drugs are also known as bronchodilators. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden shortness of breath. If sudden breathing problems occur, use your quick-relief inhaler as prescribed. Umeclidinium/vilanterol is not approved to treat asthma. People with asthma using long-acting inhaled beta agonists (such as vilanterol) without also using an inhaled corticosteroid may have an increased risk of serious (sometimes fatal) breathing problems.

How is this Glaxosmithkline Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00173086961. 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)
0173-0869-61
11-Digit CMS (5-4-2)
00173-0869-61

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