trelegy ellipta

Generic: fluticasone furoate, umeclidinium bromide and vilanterol trifenatate

Labeler: glaxosmithkline llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name trelegy ellipta
Generic Name fluticasone furoate, umeclidinium bromide and vilanterol trifenatate
Labeler glaxosmithkline llc
Dosage Form POWDER
Routes
RESPIRATORY (INHALATION)
Active Ingredients

fluticasone furoate 100 ug/1, umeclidinium bromide 62.5 ug/1, vilanterol trifenatate 25 ug/1

Manufacturer
GlaxoSmithKline LLC

Identifiers & Regulatory

Product NDC 0173-0887
Product ID 0173-0887_3adf47cb-c3b5-4fdb-9441-d90679b79687
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209482
Listing Expiration 2026-12-31
Marketing Start 2017-09-18

Pharmacologic Class

Classes
adrenergic beta2-agonists [moa] anticholinergic [epc] cholinergic antagonists [moa] corticosteroid hormone receptor agonists [moa] corticosteroid [epc] beta2-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01730887
Hyphenated Format 0173-0887

Supplemental Identifiers

RxCUI
1945039 1945044 1945047 1945048 2395769 2395771 2395774 2395775
UNII
JS86977WNV 7AN603V4JV 40AHO2C6DG

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name trelegy ellipta (source: ndc)
Generic Name fluticasone furoate, umeclidinium bromide and vilanterol trifenatate (source: ndc)
Application Number NDA209482 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 100 ug/1
  • 62.5 ug/1
  • 25 ug/1
source: ndc
Packaging
  • 1 TRAY in 1 CARTON (0173-0887-10) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER
  • 1 TRAY in 1 CARTON (0173-0887-14) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER
  • 1 TRAY in 1 CARTON (0173-0887-61) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER
source: ndc

Packages (3)

0173-0887-10 1 TRAY in 1 CARTON (0173-0887-10) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER 0173-0887-14 1 TRAY in 1 CARTON (0173-0887-14) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER 0173-0887-61 1 TRAY in 1 CARTON (0173-0887-61) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER

Ingredients (3)

fluticasone furoate (100 ug/1) umeclidinium bromide (62.5 ug/1) vilanterol trifenatate (25 ug/1)

Linked Drug Pages (1)

Trelegy Ellipta ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "3adf47cb-c3b5-4fdb-9441-d90679b79687", "openfda": {"unii": ["JS86977WNV", "7AN603V4JV", "40AHO2C6DG"], "rxcui": ["1945039", "1945044", "1945047", "1945048", "2395769", "2395771", "2395774", "2395775"], "spl_set_id": ["b5a81d5a-4648-4c7a-951d-33c014a63c7e"], "manufacturer_name": ["GlaxoSmithKline LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TRAY in 1 CARTON (0173-0887-10)  / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER", "package_ndc": "0173-0887-10", "marketing_start_date": "20170918"}, {"sample": false, "description": "1 TRAY in 1 CARTON (0173-0887-14)  / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER", "package_ndc": "0173-0887-14", "marketing_start_date": "20170918"}, {"sample": true, "description": "1 TRAY in 1 CARTON (0173-0887-61)  / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER", "package_ndc": "0173-0887-61", "marketing_start_date": "20170918"}], "brand_name": "Trelegy Ellipta", "product_id": "0173-0887_3adf47cb-c3b5-4fdb-9441-d90679b79687", "dosage_form": "POWDER", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "0173-0887", "generic_name": "fluticasone furoate, umeclidinium bromide and vilanterol trifenatate", "labeler_name": "GlaxoSmithKline LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Trelegy Ellipta", "active_ingredients": [{"name": "FLUTICASONE FUROATE", "strength": "100 ug/1"}, {"name": "UMECLIDINIUM BROMIDE", "strength": "62.5 ug/1"}, {"name": "VILANTEROL TRIFENATATE", "strength": "25 ug/1"}], "application_number": "NDA209482", "marketing_category": "NDA", "marketing_start_date": "20170918", "listing_expiration_date": "20261231"}