NDC Code(s) : 66993-135-97, 66993-136-97
Packager : Prasco Laboratories

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Fluticasone Furoate and Vilanterolfluticasone furoate and vilanterol POWDER
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66993-135
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUTICASONE FUROATE(UNII: JS86977WNV)
(FLUTICASONE - UNII:CUT2W21N7U) 		FLUTICASONE FUROATE100 ug
VILANTEROL TRIFENATATE(UNII: 40AHO2C6DG)
(VILANTEROL - UNII:028LZY775B) 		VILANTEROL25 ug
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:66993-135-971 in 1 CARTON 23/05/2022
11 in 1 TRAY
130 in 1 INHALER Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA204275 05/23/2022
Fluticasone Furoate and Vilanterolfluticasone furoate and vilanterol POWDER
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66993-136
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUTICASONE FUROATE(UNII: JS86977WNV)
(FLUTICASONE - UNII:CUT2W21N7U) 		FLUTICASONE FUROATE200 ug
VILANTEROL TRIFENATATE(UNII: 40AHO2C6DG)
(VILANTEROL - UNII:028LZY775B) 		VILANTEROL25 ug
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:66993-136-971 in 1 CARTON 23/05/2022
11 in 1 TRAY
130 in 1 INHALER Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA204275 05/23/2022

LABELER - Prasco Laboratories(065969375)

REGISTRANT - GlaxoSmithKline LLC(167380711)

PRINCIPAL DISPLAY PANEL

Principal Display Panel

NDC 66993-135-97

Fluticasone Furoate/Vilanterol

ELLIPTA Inhalation Powder

100 mcg/25 mcg

PRASCO

FOR ORAL INHALATION ONLY

Fluticasone Furoate/Vilanterol ELLIPTA Inhalation Powder contains 2 foil strips of 30 blisters each. Each blister on one strip contains 100 mcg of fluticasone furoate and lactose monohydrate. Each blister on the other strip contains 25 mcg of vilanterol, magnesium stearate, and lactose monohydrate.

Rx Only

1 ELLIPTA Inhaler containing 30 doses

(60 blisters total)

62000000074871

Fluticasone Furoate-Vilanterol Ellipta 100 mcg-25mcg carton

PRINCIPAL DISPLAY PANEL

Principal Display Panel

NDC 66993-136-97

Fluticasone Furoate/Vilanterol

ELLIPTA Inhalation Powder

200 mcg/25 mcg

PRASCO

FOR ORAL INHALATION ONLY

Fluticasone Furoate/Vilanterol ELLIPTA Inhalation Powder 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.

Rx Only

1 ELLIPTA Inhaler containing 30 doses

(60 blisters total)

62000000074875

Fluticasone Furoate-Vilanterol Ellipta 200mcg-25mcg carton