NDC 0173-0887

Trelegy Ellipta

Fluticasone Furoate, Umeclidinium Bromide And Vilanterol Trifenatate

Trelegy 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; Umeclidinium Bromide; Vilanterol Trifenatate.

Product ID0173-0887_0684a391-46b4-4c09-a6c4-c2a68cdae004
NDC0173-0887
Product TypeHuman Prescription Drug
Proprietary NameTrelegy Ellipta
Generic NameFluticasone Furoate, Umeclidinium Bromide And Vilanterol Trifenatate
Dosage FormPowder
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2017-09-18
Marketing CategoryNDA / NDA
Application NumberNDA209482
Labeler NameGlaxoSmithKline LLC
Substance NameFLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
Active Ingredient Strength100 ug/1; ug/1; ug/1
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0173-0887-10

1 TRAY in 1 CARTON (0173-0887-10) > 1 INHALER in 1 TRAY > 30 POWDER in 1 INHALER
Marketing Start Date2017-09-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0173-0887-10 [00173088710]

Trelegy Ellipta POWDER
Marketing CategoryNDA
Application NumberNDA209482
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-09-18

NDC 0173-0887-14 [00173088714]

Trelegy Ellipta POWDER
Marketing CategoryNDA
Application NumberNDA209482
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-09-18

NDC 0173-0887-61 [00173088761]

Trelegy Ellipta POWDER
Marketing CategoryNDA
Application NumberNDA209482
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-18

Drug Details

Active Ingredients

IngredientStrength
FLUTICASONE FUROATE100 ug/1

OpenFDA Data

SPL SET ID:b5a81d5a-4648-4c7a-951d-33c014a63c7e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1945048
  • 1945044
  • 1945039
  • 1945047
  • Pharmacological Class

    • Corticosteroid [EPC]
    • Corticosteroid Hormone Receptor Agonists [MoA]
    • Anticholinergic [EPC]
    • Cholinergic Antagonists [MoA]
    • Adrenergic beta2-Agonists [MoA]
    • beta2-Adrenergic Agonist [EPC]

    NDC Crossover Matching brand name "Trelegy Ellipta" or generic name "Fluticasone Furoate, Umeclidinium Bromide And Vilanterol Trifenatate"

    NDCBrand NameGeneric Name
    0173-0887Trelegy Elliptafluticasone furoate, umeclidinium bromide and vilanterol trifenatate
    0173-0893Trelegy Elliptafluticasone furoate, umeclidinium bromide and vilanterol trifenatate

    Trademark Results [Trelegy Ellipta]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TRELEGY ELLIPTA
    TRELEGY ELLIPTA
    88196660 not registered Live/Pending
    Glaxo Group Limited
    2018-11-16

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