breo ellipta

Generic: fluticasone furoate and vilanterol trifenatate

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

Drug Facts

Product Profile

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

fluticasone furoate 100 ug/1, vilanterol trifenatate 25 ug/1

Manufacturer
GlaxoSmithKline LLC

Identifiers & Regulatory

Product NDC 0173-0859
Product ID 0173-0859_03107b41-0bf9-463a-a6e4-956444373e81
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA204275
Listing Expiration 2026-12-31
Marketing Start 2013-08-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01730859
Hyphenated Format 0173-0859

Supplemental Identifiers

RxCUI
1424889 1424899 1539891 1539893 1648783 1648785 1648788 1648789 2637473 2637476
UNII
JS86977WNV 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 breo ellipta (source: ndc)
Generic Name fluticasone furoate and vilanterol trifenatate (source: ndc)
Application Number NDA204275 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 100 ug/1
  • 25 ug/1
source: ndc
Packaging
  • 1 TRAY in 1 CARTON (0173-0859-10) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER
  • 1 TRAY in 1 CARTON (0173-0859-14) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER
source: ndc

Packages (2)

0173-0859-10 1 TRAY in 1 CARTON (0173-0859-10) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER 0173-0859-14 1 TRAY in 1 CARTON (0173-0859-14) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER

Ingredients (2)

fluticasone furoate (100 ug/1) vilanterol trifenatate (25 ug/1)

Linked Drug Pages (1)

Breo Ellipta ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "03107b41-0bf9-463a-a6e4-956444373e81", "openfda": {"unii": ["JS86977WNV", "40AHO2C6DG"], "rxcui": ["1424889", "1424899", "1539891", "1539893", "1648783", "1648785", "1648788", "1648789", "2637473", "2637476"], "spl_set_id": ["96428df1-ea05-431a-98d3-1ec2c4b63878"], "manufacturer_name": ["GlaxoSmithKline LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TRAY in 1 CARTON (0173-0859-10)  / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER", "package_ndc": "0173-0859-10", "marketing_start_date": "20130826"}, {"sample": false, "description": "1 TRAY in 1 CARTON (0173-0859-14)  / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER", "package_ndc": "0173-0859-14", "marketing_start_date": "20130826"}], "brand_name": "Breo Ellipta", "product_id": "0173-0859_03107b41-0bf9-463a-a6e4-956444373e81", "dosage_form": "POWDER", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "0173-0859", "generic_name": "fluticasone furoate and vilanterol trifenatate", "labeler_name": "GlaxoSmithKline LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Breo Ellipta", "active_ingredients": [{"name": "FLUTICASONE FUROATE", "strength": "100 ug/1"}, {"name": "VILANTEROL TRIFENATATE", "strength": "25 ug/1"}], "application_number": "NDA204275", "marketing_category": "NDA", "marketing_start_date": "20130826", "listing_expiration_date": "20261231"}