NDC 70518-2028

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 Remedyrepack Inc.. The primary component is Fluticasone Furoate; Vilanterol Trifenatate.

• Product ID: 70518-2028_86bfbbaa-9de6-2805-e053-2991aa0a8c58
• NDC: 70518-2028
• 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: 2019-04-17
• Marketing Category: NDA / NDA
• Application Number: NDA204275
• Labeler Name: REMEDYREPACK INC.
• Substance Name: FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
• Active Ingredient Strength: 100 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 70518-2028-0

1 TRAY in 1 CARTON (70518-2028-0) > 1 INHALER in 1 TRAY > 30 POWDER in 1 INHALER

• Marketing Start Date: 2019-04-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70518-2028-0 [70518202800]

Breo Ellipta POWDER

• Marketing Category: NDA
• Application Number: NDA204275
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-04-17

Drug Details

Active Ingredients

Ingredient	Strength
FLUTICASONE FUROATE	100 ug/1

OpenFDA Data

• SPL SET ID: 37bfbe82-e68e-44d3-98f1-e9f71eb92fc9
• Manufacturer:
  • REMEDYREPACK INC.
• UNII:
  • 40AHO2C6DG
  • JS86977WNV

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