incruse ellipta

Generic: umeclidinium

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

Drug Facts

Product Profile

Brand Name incruse ellipta
Generic Name umeclidinium
Labeler glaxosmithkline llc
Dosage Form AEROSOL, POWDER
Routes
ORAL
Active Ingredients

umeclidinium bromide 62.5 ug/1

Manufacturer
GlaxoSmithKline LLC

Identifiers & Regulatory

Product NDC 0173-0873
Product ID 0173-0873_44e97b9b-e22d-4bef-a025-20e71b0b3966
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA205382
Listing Expiration 2026-12-31
Marketing Start 2014-04-30

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01730873
Hyphenated Format 0173-0873

Supplemental Identifiers

RxCUI
1539251 1539885 1596444 1596445
UNII
7AN603V4JV

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 incruse ellipta (source: ndc)
Generic Name umeclidinium (source: ndc)
Application Number NDA205382 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 62.5 ug/1
source: ndc
Packaging
  • 1 TRAY in 1 CARTON (0173-0873-06) / 1 INHALER in 1 TRAY / 7 AEROSOL, POWDER in 1 INHALER
  • 1 TRAY in 1 CARTON (0173-0873-10) / 1 INHALER in 1 TRAY / 30 AEROSOL, POWDER in 1 INHALER
source: ndc

Packages (2)

0173-0873-06 1 TRAY in 1 CARTON (0173-0873-06) / 1 INHALER in 1 TRAY / 7 AEROSOL, POWDER in 1 INHALER 0173-0873-10 1 TRAY in 1 CARTON (0173-0873-10) / 1 INHALER in 1 TRAY / 30 AEROSOL, POWDER in 1 INHALER

Ingredients (1)

umeclidinium bromide (62.5 ug/1)

Linked Drug Pages (1)

Incruse Ellipta ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "44e97b9b-e22d-4bef-a025-20e71b0b3966", "openfda": {"unii": ["7AN603V4JV"], "rxcui": ["1539251", "1539885", "1596444", "1596445"], "spl_set_id": ["dbb64747-1505-49d7-9a33-99dd402e96d3"], "manufacturer_name": ["GlaxoSmithKline LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TRAY in 1 CARTON (0173-0873-06)  / 1 INHALER in 1 TRAY / 7 AEROSOL, POWDER in 1 INHALER", "package_ndc": "0173-0873-06", "marketing_start_date": "20140430"}, {"sample": false, "description": "1 TRAY in 1 CARTON (0173-0873-10)  / 1 INHALER in 1 TRAY / 30 AEROSOL, POWDER in 1 INHALER", "package_ndc": "0173-0873-10", "marketing_start_date": "20140430"}], "brand_name": "Incruse Ellipta", "product_id": "0173-0873_44e97b9b-e22d-4bef-a025-20e71b0b3966", "dosage_form": "AEROSOL, POWDER", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "0173-0873", "generic_name": "umeclidinium", "labeler_name": "GlaxoSmithKline LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Incruse Ellipta", "active_ingredients": [{"name": "UMECLIDINIUM BROMIDE", "strength": "62.5 ug/1"}], "application_number": "NDA205382", "marketing_category": "NDA", "marketing_start_date": "20140430", "listing_expiration_date": "20261231"}