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 ID: 0173-0887_0684a391-46b4-4c09-a6c4-c2a68cdae004
• NDC: 0173-0887
• Product Type: Human Prescription Drug
• Proprietary Name: Trelegy Ellipta
• Generic Name: Fluticasone Furoate, Umeclidinium Bromide And Vilanterol Trifenatate
• Dosage Form: Powder
• Route of Administration: RESPIRATORY (INHALATION)
• Marketing Start Date: 2017-09-18
• Marketing Category: NDA / NDA
• Application Number: NDA209482
• Labeler Name: GlaxoSmithKline LLC
• Substance Name: FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
• Active Ingredient Strength: 100 ug/1; ug/1; ug/1
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

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 Date: 2017-09-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0173-0887-10 [00173088710]

Trelegy Ellipta POWDER

• Marketing Category: NDA
• Application Number: NDA209482
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-09-18

NDC 0173-0887-14 [00173088714]

Trelegy Ellipta POWDER

• Marketing Category: NDA
• Application Number: NDA209482
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-09-18

NDC 0173-0887-61 [00173088761]

Trelegy Ellipta POWDER

• Marketing Category: NDA
• Application Number: NDA209482
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-09-18

Drug Details

Active Ingredients

Ingredient	Strength
FLUTICASONE FUROATE	100 ug/1

OpenFDA Data

• SPL SET ID: b5a81d5a-4648-4c7a-951d-33c014a63c7e
• Manufacturer:
  • GlaxoSmithKline LLC
• UNII:
  • 40AHO2C6DG
  • JS86977WNV
  • 7AN603V4JV
• 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"

NDC	Brand Name	Generic Name
0173-0887	Trelegy Ellipta	fluticasone furoate, umeclidinium bromide and vilanterol trifenatate
0173-0893	Trelegy Ellipta	fluticasone furoate, umeclidinium bromide and vilanterol trifenatate