Breo Ellipta

Product NDC

50090-2404

11-digit product format

500902404

Labeler code

50090

Product ID

50090-2404_5b5dae35-bf7b-48f9-9e04-fa83ce96c135

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

fluticasone furoate and vilanterol trifenatate

Dosage form

POWDER

Route

RESPIRATORY (INHALATION)

Labeler

A-S Medication Solutions

Application

NDA204275

Marketing category

NDA

Marketing start

2015-04-30

Marketing end

0000-00-00

Substance

FLUTICASONE FUROATE; VILANTEROL TRIFENATATE

Active strength

200 ug/1; ug/1

Pharmacologic classes

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

NDC exclude flag

E

Listing certified through

2017-12-31

Current FDA listing

Historical FDA.report record