Breo Ellipta
These highlights do not include all the information needed to use BREO ELLIPTA safely and effectively. See full prescribing information for BREO ELLIPTA.BREO ELLIPTA (fluticasone furoate and vilanterol inhalation powder), for oral inhalation useInitial U.S. Approval: 2013
Approved
Approval ID
96428df1-ea05-431a-98d3-1ec2c4b63878
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 12, 2023
Manufacturers
FDA
GlaxoSmithKline LLC
DUNS: 167380711
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
fluticasone furoate and vilanterol trifenatate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0173-0859
Application NumberNDA204275
Product Classification
M
Marketing Category
C73594
G
Generic Name
fluticasone furoate and vilanterol trifenatate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateMay 12, 2023
FDA Product Classification
INGREDIENTS (4)
FLUTICASONE FUROATEActive
Quantity: 100 ug in 1 1
Code: JS86977WNV
Classification: ACTIB
VILANTEROL TRIFENATATEActive
Quantity: 25 ug in 1 1
Code: 40AHO2C6DG
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
fluticasone furoate and vilanterol trifenatate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0173-0916
Application NumberNDA204275
Product Classification
M
Marketing Category
C73594
G
Generic Name
fluticasone furoate and vilanterol trifenatate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateMay 12, 2023
FDA Product Classification
INGREDIENTS (4)
FLUTICASONE FUROATEActive
Quantity: 50 ug in 1 1
Code: JS86977WNV
Classification: ACTIB
VILANTEROL TRIFENATATEActive
Quantity: 25 ug in 1 1
Code: 40AHO2C6DG
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
fluticasone furoate and vilanterol trifenatate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0173-0882
Application NumberNDA204275
Product Classification
M
Marketing Category
C73594
G
Generic Name
fluticasone furoate and vilanterol trifenatate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateMay 12, 2023
FDA Product Classification
INGREDIENTS (4)
FLUTICASONE FUROATEActive
Quantity: 200 ug in 1 1
Code: JS86977WNV
Classification: ACTIB
VILANTEROL TRIFENATATEActive
Quantity: 25 ug in 1 1
Code: 40AHO2C6DG
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT