NDC 0173-0882

Breo Ellipta

Fluticasone Furoate And Vilanterol Trifenatate

Breo 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; Vilanterol Trifenatate.

• Product ID: 0173-0882_0548cd1e-ded7-4db1-8023-e1d828337e87
• NDC: 0173-0882
• Product Type: Human Prescription Drug
• Proprietary Name: Breo Ellipta
• Generic Name: Fluticasone Furoate And Vilanterol Trifenatate
• Dosage Form: Powder
• Route of Administration: RESPIRATORY (INHALATION)
• Marketing Start Date: 2015-04-30
• Marketing Category: NDA / NDA
• Application Number: NDA204275
• Labeler Name: GlaxoSmithKline LLC
• Substance Name: FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
• Active Ingredient Strength: 200 ug/1; ug/1
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0173-0882-10

1 TRAY in 1 CARTON (0173-0882-10) > 1 INHALER in 1 TRAY > 30 POWDER in 1 INHALER

• Marketing Start Date: 2015-04-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0173-0882-14 [00173088214]

Breo Ellipta POWDER

• Marketing Category: NDA
• Application Number: NDA204275
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-04-30

NDC 0173-0882-61 [00173088261]

Breo Ellipta POWDER

• Marketing Category: NDA
• Application Number: NDA204275
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-04-30

NDC 0173-0882-10 [00173088210]

Breo Ellipta POWDER

• Marketing Category: NDA
• Application Number: NDA204275
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-04-30

Drug Details

Active Ingredients

Ingredient	Strength
FLUTICASONE FUROATE	200 ug/1

OpenFDA Data

• SPL SET ID: 96428df1-ea05-431a-98d3-1ec2c4b63878
• Manufacturer:
  • GlaxoSmithKline LLC
• UNII:
  • 40AHO2C6DG
  • JS86977WNV
• RxNorm Concept Unique ID - RxCUI:
  • 1648783
  • 1539893
  • 1648785
  • 1539891
  • 1648789
  • 1648788
  • 1424899
  • 1424889

Pharmacological Class

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

NDC Crossover Matching brand name "Breo Ellipta" or generic name "Fluticasone Furoate And Vilanterol Trifenatate"

NDC	Brand Name	Generic Name
0173-0859	Breo Ellipta	fluticasone furoate and vilanterol trifenatate
0173-0882	Breo Ellipta	fluticasone furoate and vilanterol trifenatate
50090-2404	Breo Ellipta	fluticasone furoate and vilanterol trifenatate
70518-2028	Breo Ellipta	fluticasone furoate and vilanterol trifenatate