Fluticasone Propionate and Salmeterol DISKUS (Page 13 of 13)

Medication Guide

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PRINCIPAL DISPLAY PANEL

NDC 71205-262-60

Fluticasone Propionate/Salmeterol*

DISKUS Inhalation Powder

250/50 mcg

FOR ORAL INHALATION ONLY

* Each blister contains 250 mcg of fluticasone propionate and 72.5 mcg of salmeterol xinafoate, equivalent to 50 mcg of salmeterol base, with lactose.

Rx only

1 DISKUS Inhalation Device Containing 1 Foil Strip of 60 Blisters

10000000149139 Rev. 4/18
71205-262-60
(click image for full-size original)
FLUTICASONE PROPIONATE AND SALMETEROL DISKUS fluticasone propionate and salmeterol powder
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71205-262(NDC:66993-585)
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUTICASONE PROPIONATE (FLUTICASONE) FLUTICASONE PROPIONATE 250 ug
SALMETEROL XINAFOATE (SALMETEROL) SALMETEROL 50 ug
Inactive Ingredients
Ingredient Name Strength
LACTOSE, UNSPECIFIED FORM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71205-262-60 1 INHALER in 1 CARTON contains a INHALER
1 60 POWDER in 1 INHALER This package is contained within the CARTON (71205-262-60)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA021077 02/08/2019
Labeler — Proficient Rx LP (079196022)
Establishment
Name Address ID/FEI Operations
Proficient Rx LP 079196022 REPACK (71205-262), RELABEL (71205-262)

Revised: 01/2020 Proficient Rx LP

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