RELENZA (Page 6 of 6)

Principal Display Panel

NDC 68258-3030-1

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 label
(click image for full-size original)
RELENZA
zanamivir powder
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68258-3030(NDC:0173-0681-01)
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:68258-3030-1 5 PACKAGE (PACKAGE) in 1 CARTON contains a PACKAGE
1 4 POWDER (BLISTER) in 1 PACKAGE This package is contained within the CARTON (68258-3030-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021036 12/22/2002
Labeler — Dispensing Solutions Inc. (066070785)
Establishment
Name Address ID/FEI Operations
Dispensing Solutions Inc. 066070785 repack, relabel

Revised: 03/2010 Dispensing Solutions Inc.

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