RELENZA (Page 6 of 6)

PRINCIPAL DISPLAY PANEL

NDC 54868-4377-0

image of 5 mg package label
(click image for full-size original)

RELENZA®

(ZANAMIVIR) INHALATION POWDER

5 ROTADISKS® each containing 4 blisters

5 mg

FOR ORAL INHALATION ONLY

Each blister contains 5 mg zanamivir with lactose.

Store at 25o C (77o F); excursions permitted to 15o to 30o C (59o to 86o F) (see USP Controlled Room Temperature).

Rx only

See prescribing information for dosage information.

RELENZA
zanamivir powder
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4377(NDC:0173-0681)
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZANAMIVIR (ZANAMIVIR) ZANAMIVIR 5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-4377-0 5 PACKAGE (PACKAGE) in 1 CARTON contains a PACKAGE
1 4 POWDER (BLISTER) in 1 PACKAGE This package is contained within the CARTON (54868-4377-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021036 01/20/2009
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel

Revised: 03/2010 Physicians Total Care, Inc.

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