NDC 0173-0873

Incruse Ellipta

Umeclidinium

Incruse Ellipta is a Oral Aerosol, Powder in the Human Prescription Drug category. It is labeled and distributed by Glaxosmithkline Llc. The primary component is Umeclidinium Bromide.

Product ID0173-0873_17222848-80fc-4db8-9f29-b9c0b1cb0683
NDC0173-0873
Product TypeHuman Prescription Drug
Proprietary NameIncruse Ellipta
Generic NameUmeclidinium
Dosage FormAerosol, Powder
Route of AdministrationORAL
Marketing Start Date2014-04-30
Marketing CategoryNDA / NDA
Application NumberNDA205382
Labeler NameGlaxoSmithKline LLC
Substance NameUMECLIDINIUM BROMIDE
Active Ingredient Strength63 ug/1
Pharm ClassesAnticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0173-0873-06

1 TRAY in 1 CARTON (0173-0873-06) > 1 INHALER in 1 TRAY > 7 AEROSOL, POWDER in 1 INHALER
Marketing Start Date2014-04-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0173-0873-61 [00173087361]

Incruse Ellipta AEROSOL, POWDER
Marketing CategoryNDA
Application NumberNDA205382
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-04-30

NDC 0173-0873-10 [00173087310]

Incruse Ellipta AEROSOL, POWDER
Marketing CategoryNDA
Application NumberNDA205382
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-04-30

NDC 0173-0873-06 [00173087306]

Incruse Ellipta AEROSOL, POWDER
Marketing CategoryNDA
Application NumberNDA205382
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-04-30

Drug Details

Active Ingredients

IngredientStrength
UMECLIDINIUM BROMIDE62.5 ug/1

OpenFDA Data

SPL SET ID:dbb64747-1505-49d7-9a33-99dd402e96d3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1539885
  • 1539251
  • 1596444
  • 1596445

    • Pharmacological Class

    • Anticholinergic [EPC]
    • Cholinergic Antagonists [MoA]

    Trademark Results [Incruse Ellipta]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    INCRUSE ELLIPTA
    INCRUSE ELLIPTA
    86236331 5186819 Live/Registered
    Glaxo Group Limited
    2014-03-29
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