BREO ELLIPTA- fluticasone furoate and vilanterol trifenatate powder 
Glaxo Operations UK Ltd

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PRINCIPAL DISPLAY PANEL

NDC 0173-0859-10

BREO® ELLIPTA® 100/25

(fluticasone furoate 100 mcg and vilanterol 25 mcg inhalation powder)

100 mcg/25 mcg

Rx Only

FOR ORAL INHALATION ONLY

BREO ELLIPTA contains 2 foil strips of 30 blisters each. Each blister on one strip contains 100 mcg of fluticasone furoate and latose monohydrate. Each blister on the other strip contains 25 mcg of vilanterol, magnesium stearate, and lactose monohydrate.

Federal Law requires the dispensing of BREO ELLIPTA with the Medication Guide inside the carton.

1 ELLIPTA® Inhaler containing 30 doses (60 blisters total)

GlaxoSmithKline, RTP, NC 27709

 
10000000142559 Rev. 8/16
Breo Ellipta 100mcg-25mcg 30 dose carton

PRINCIPAL DISPLAY PANEL

NDC 0173-0882-10

BREO® ELLIPTA® 200/25

(fluticasone furoate 200 mcg and vilanterol 25 mcg inhalation powder)

200 mcg/25 mcg

Rx Only

FOR ORAL INHALATION ONLY

BREO ELLIPTA contains 2 foil strips of 30 blisters each. Each blister on one strip contains 200 mcg of fluticasone furoate and lactose monohydrate. Each blister on the other strip contains 25 mcg of vilanterol, magnesium stearate, and lactose monohydrate.

Federal Law requires the dispensing of BREO ELLIPTA with the Medication Guide inside the carton.

1 ELLIPTA® Inhaler containing 30 doses (60 blisters total)

 
10000000142647 Rev. 10/16
Breo Ellipta 200 mcg-25mcg 30 dose carton
BREO ELLIPTA 
fluticasone furoate and vilanterol trifenatate powder
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63379-017
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FLUTICASONE FUROATE (UNII: JS86977WNV) (FLUTICASONE - UNII:CUT2W21N7U) FLUTICASONE FUROATE100 ug
VILANTEROL TRIFENATATE (UNII: 40AHO2C6DG) (VILANTEROL - UNII:028LZY775B) VILANTEROL25 ug
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63379-017-001 in 1 CARTON08/26/2013
11 in 1 TRAY
130 in 1 INHALER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:63379-017-011 in 1 CARTON08/26/2013
21 in 1 TRAY
214 in 1 INHALER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3NDC:63379-017-021 in 1 CARTON08/26/2013
31 in 1 TRAY
314 in 1 INHALER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractNDA20427508/26/2013
BREO ELLIPTA 
fluticasone furoate and vilanterol trifenatate powder
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63379-059
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FLUTICASONE FUROATE (UNII: JS86977WNV) (FLUTICASONE - UNII:CUT2W21N7U) FLUTICASONE FUROATE200 ug
VILANTEROL TRIFENATATE (UNII: 40AHO2C6DG) (VILANTEROL - UNII:028LZY775B) VILANTEROL25 ug
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63379-059-001 in 1 CARTON04/30/2015
11 in 1 TRAY
130 in 1 INHALER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:63379-059-011 in 1 CARTON04/30/2015
21 in 1 TRAY
214 in 1 INHALER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3NDC:63379-059-021 in 1 CARTON04/30/2015
31 in 1 TRAY
314 in 1 INHALER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractNDA20427504/30/2015
Labeler - Glaxo Operations UK Ltd (424738227)

Revised: 12/2017
 
Glaxo Operations UK Ltd