NDC Code(s) : 0173-0869-10, 0173-0869-06, 0173-0869-61
Packager : GlaxoSmithKline LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Anoro Elliptaumeclidinium bromide and vilanterol trifenatate POWDER
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0173-0869
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
UMECLIDINIUM BROMIDE(UNII: 7AN603V4JV)
(UMECLIDINIUM - UNII:GE2T1418SV) 		UMECLIDINIUM62.5 ug
VILANTEROL TRIFENATATE(UNII: 40AHO2C6DG)
(VILANTEROL - UNII:028LZY775B) 		VILANTEROL25 ug
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE(UNII: 70097M6I30)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0173-0869-101 in 1 CARTON 31/01/2014
11 in 1 TRAY
130 in 1 INHALER Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:0173-0869-061 in 1 CARTON 31/01/2014
21 in 1 TRAY
27 in 1 INHALER Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3NDC:0173-0869-611 in 1 CARTON 31/01/2014
31 in 1 TRAY
37 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 NDA203975 01/31/2014

LABELER - GlaxoSmithKline LLC(167380711)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 0173-0869-10

ANORO ELLIPTA

(umeclidinium and vilanterol inhalation powder)

62.5 mcg/25 mcg

Rx Only

FOR ORAL INHALATION ONLY

Each blister on one strip contains 62.5 mcg of umeclidinium, magnesium stearate, and lactose monohydrate. Each blister on the other strip contains 25 mcg of vilanterol, magnesium stearate, and lactose monohydrate.

1 ELLIPTA Inhaler containing 30 doses (60 blisters total)

GSK

©2023 GSK group of companies or its licensor.

  •  62000000084535 Rev.1/23
  •   Anoro Ellipta 30 dose carton