NDC 0173-0888

Arnuity Ellipta

Fluticasone Furoate

Arnuity Ellipta is a Respiratory (inhalation) Powder in the Human Prescription Drug category. It is labeled and distributed by Glaxosmithkline Llc. The primary component is Fluticasone Furoate.

Product ID0173-0888_3978a61b-f15c-42a7-94dc-0e77d6f2dcd4
NDC0173-0888
Product TypeHuman Prescription Drug
Proprietary NameArnuity Ellipta
Generic NameFluticasone Furoate
Dosage FormPowder
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2018-05-17
Marketing CategoryNDA / NDA
Application NumberNDA205625
Labeler NameGlaxoSmithKline LLC
Substance NameFLUTICASONE FUROATE
Active Ingredient Strength50 ug/1
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0173-0888-10

1 INHALER in 1 CARTON (0173-0888-10) > 30 POWDER in 1 INHALER
Marketing Start Date2018-05-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0173-0888-62 [00173088862]

Arnuity Ellipta POWDER
Marketing CategoryNDA
Application NumberNDA205625
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-05-17

NDC 0173-0888-10 [00173088810]

Arnuity Ellipta POWDER
Marketing CategoryNDA
Application NumberNDA205625
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-05-17

Drug Details

Active Ingredients

IngredientStrength
FLUTICASONE FUROATE50 ug/1

OpenFDA Data

SPL SET ID:50f193ee-1691-486d-9370-a664df63695c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1547660
  • 1547672
  • 1547671
  • 1547663
  • 1547664
  • 1547658
  • 1547666
  • 1547668
  • 2045382
  • 2045377

    • Pharmacological Class

    • Corticosteroid [EPC]
    • Corticosteroid Hormone Receptor Agonists [MoA]

    NDC Crossover Matching brand name "Arnuity Ellipta" or generic name "Fluticasone Furoate"

    NDCBrand NameGeneric Name
    0173-0874Arnuity Elliptafluticasone furoate
    0173-0876Arnuity Elliptafluticasone furoate
    0173-0888Arnuity Elliptafluticasone furoate
    0135-0615FLONASE SENSIMISTfluticasone furoate
    0135-0616FLONASE SENSIMISTfluticasone furoate
    50090-5967FLONASE SENSIMISTfluticasone furoate
    50090-6075FLONASE SENSIMISTfluticasone furoate
    0173-0753VERAMYSTfluticasone furoate

    Trademark Results [Arnuity Ellipta]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ARNUITY ELLIPTA
    ARNUITY ELLIPTA
    86230290 4823045 Live/Registered
    Glaxo Group Limited
    2014-03-24
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.