anoro ellipta

Generic: umeclidinium bromide and vilanterol trifenatate

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

Drug Facts

Product Profile

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

umeclidinium bromide 62.5 ug/1, vilanterol trifenatate 25 ug/1

Manufacturer
GlaxoSmithKline LLC

Identifiers & Regulatory

Product NDC 0173-0869
Product ID 0173-0869_90be6e26-9d2d-4b9d-8378-5e38c3076720
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA203975
Listing Expiration 2026-12-31
Marketing Start 2014-01-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01730869
Hyphenated Format 0173-0869

Supplemental Identifiers

RxCUI
1487519 1487524 1487527 1487528
UNII
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 anoro ellipta (source: ndc)
Generic Name umeclidinium bromide and vilanterol trifenatate (source: ndc)
Application Number NDA203975 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 62.5 ug/1
  • 25 ug/1
source: ndc
Packaging
  • 1 TRAY in 1 CARTON (0173-0869-06) / 1 INHALER in 1 TRAY / 7 POWDER in 1 INHALER
  • 1 TRAY in 1 CARTON (0173-0869-10) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER
source: ndc

Packages (2)

0173-0869-06 1 TRAY in 1 CARTON (0173-0869-06) / 1 INHALER in 1 TRAY / 7 POWDER in 1 INHALER 0173-0869-10 1 TRAY in 1 CARTON (0173-0869-10) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER

Ingredients (2)

umeclidinium bromide (62.5 ug/1) vilanterol trifenatate (25 ug/1)

Linked Drug Pages (1)

Anoro Ellipta ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "90be6e26-9d2d-4b9d-8378-5e38c3076720", "openfda": {"unii": ["7AN603V4JV", "40AHO2C6DG"], "rxcui": ["1487519", "1487524", "1487527", "1487528"], "spl_set_id": ["2dbd0671-c565-40c5-bf0f-e324db26799c"], "manufacturer_name": ["GlaxoSmithKline LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TRAY in 1 CARTON (0173-0869-06)  / 1 INHALER in 1 TRAY / 7 POWDER in 1 INHALER", "package_ndc": "0173-0869-06", "marketing_start_date": "20140131"}, {"sample": false, "description": "1 TRAY in 1 CARTON (0173-0869-10)  / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER", "package_ndc": "0173-0869-10", "marketing_start_date": "20140131"}], "brand_name": "Anoro Ellipta", "product_id": "0173-0869_90be6e26-9d2d-4b9d-8378-5e38c3076720", "dosage_form": "POWDER", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "0173-0869", "generic_name": "umeclidinium bromide and vilanterol trifenatate", "labeler_name": "GlaxoSmithKline LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Anoro Ellipta", "active_ingredients": [{"name": "UMECLIDINIUM BROMIDE", "strength": "62.5 ug/1"}, {"name": "VILANTEROL TRIFENATATE", "strength": "25 ug/1"}], "application_number": "NDA203975", "marketing_category": "NDA", "marketing_start_date": "20140131", "listing_expiration_date": "20261231"}