NDC 0173-0869

Anoro Ellipta

Umeclidinium Bromide And Vilanterol Trifenatate

Anoro Ellipta is a Respiratory (inhalation) Powder in the Human Prescription Drug category. It is labeled and distributed by Glaxosmithkline Llc. The primary component is Umeclidinium Bromide; Vilanterol Trifenatate.

Product ID0173-0869_0da3b67c-1baa-4cd2-b7af-f7a969b1040b
NDC0173-0869
Product TypeHuman Prescription Drug
Proprietary NameAnoro Ellipta
Generic NameUmeclidinium Bromide And Vilanterol Trifenatate
Dosage FormPowder
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2014-01-31
Marketing CategoryNDA / NDA
Application NumberNDA203975
Labeler NameGlaxoSmithKline LLC
Substance NameUMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
Active Ingredient Strength63 ug/1; ug/1
Pharm ClassesAnticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0173-0869-06

1 TRAY in 1 CARTON (0173-0869-06) > 1 INHALER in 1 TRAY > 7 POWDER in 1 INHALER
Marketing Start Date2014-01-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0173-0869-06 [00173086906]

Anoro Ellipta POWDER
Marketing CategoryNDA
Application NumberNDA203975
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-01-31

NDC 0173-0869-61 [00173086961]

Anoro Ellipta POWDER
Marketing CategoryNDA
Application NumberNDA203975
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-01-31

NDC 0173-0869-10 [00173086910]

Anoro Ellipta POWDER
Marketing CategoryNDA
Application NumberNDA203975
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-01-31

Drug Details

Active Ingredients

IngredientStrength
UMECLIDINIUM BROMIDE62.5 ug/1

OpenFDA Data

SPL SET ID:2dbd0671-c565-40c5-bf0f-e324db26799c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1487528
  • 1487524
  • 1487519
  • 1487527
  • Pharmacological Class

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

    Trademark Results [Anoro Ellipta]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ANORO ELLIPTA
    ANORO ELLIPTA
    85831335 4552628 Live/Registered
    Glaxo Group Limited
    2013-01-24
    ANORO ELLIPTA
    ANORO ELLIPTA
    85727843 not registered Dead/Abandoned
    Glaxo Group Limited
    2012-09-13

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