Trelegy Ellipta Powder
NDC Package 0173-0887-10
Package Information
Trelegy Ellipta (fluticasone furoate, umeclidinium bromide and vilanterol trifenatate) powders is a medication used to control and prevent symptoms (such as wheezing and shortness of breath) caused by asthma and 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 0173-0887 and is authorized under FDA application NDA209482.
Identification & Billing
- RxCUI: 1945039 - fluticasone furoate 100 MCG/ACTUAT / umeclidinium 62.5 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT Dry Powder Inhaler, 14 Blisters
- RxCUI: 1945039 - 14 ACTUAT fluticasone furoate 0.1 MG/ACTUAT / umeclidinium 0.0625 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler
- RxCUI: 1945039 - fluticasone furoate 100 MCG/ACTUAT / umeclidinium (as umeclidinium Br) 62.5 MCG/ACTUAT / vilanterol (as vilanterol trifenatate) 25 MCG/ACTUAT Dry Powder Inhaler, 14 ACTUAT
- RxCUI: 1945044 - TRELEGY ELLIPTA 100 MCG / 62.5 MCG / 25 MCG Dry Powder Inhaler, 14 Blisters
- RxCUI: 1945044 - 14 ACTUAT fluticasone furoate 0.1 MG/ACTUAT / umeclidinium 0.0625 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler [Trelegy]
Clinical Specifications
- Adrenergic beta2-Agonists - [MoA] (Mechanism of Action)
- Anticholinergic - [EPC] (Established Pharmacologic Class)
- Cholinergic Antagonists - [MoA] (Mechanism of Action)
- Corticosteroid Hormone Receptor Agonists - [MoA] (Mechanism of Action)
- Corticosteroid - [EPC] (Established Pharmacologic Class)
- beta2-Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
Regulatory & Marketing
Hierarchy Structure
- 0173 - Glaxosmithkline Llc
- 0173-0887 - Trelegy Ellipta
- 0173-0887-10 - 1 TRAY in 1 CARTON / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER
- 0173-0887 - Trelegy Ellipta
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 (0173-0887). Click a package code to view its specific billing and regulatory data.
* 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 0173-0887-10 identifies a specific commercial package of 1 tray in 1 carton / 1 inhaler in 1 tray / 30 powder in 1 inhaler of Trelegy Ellipta, a human prescription drug labeled by Glaxosmithkline Llc. This powder is formulated for respiratory (inhalation) use and contains fluticasone furoate; 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 September 18, 2017. 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 asthma and 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 3 medications: fluticasone, umeclidinium, and vilanterol. Fluticasone belongs to a class of drugs known as corticosteroids. It works by reducing swelling of the airways in the lungs to make breathing easier. Umeclidinium belongs to a class of drugs known as anticholinergics and vilanterol is a LABA medication. Both drugs work by relaxing the muscles around the airways so that they open up and you can breathe more easily. Both drugs are also known as bronchodilators. When used alone, long-acting beta agonists (such as vilanterol) may rarely increase the risk of serious (sometimes fatal) asthma-related breathing problems. However, combination products containing both an inhaled corticosteroid and long-acting beta agonist, 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 two asthma-control medications (such as inhaled corticosteroid and long-acting beta agonist) or if your symptoms need combination treatment. 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.
How is this Glaxosmithkline Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 00173088710. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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:
Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.