Sancuso (Page 4 of 4)

PRINCIPAL DISPLAY PANEL


NDC 54868-5985-0

Sancuso®
(Granisetron Transdermal System)
3.1 mg/24 hours

Rx Only

7 day patchEach 52 cm2 patch contains 34.3 mg of granisetron in an acrylate-vinylacetate copolymer adhesive

1 patch

www.sancuso.com

image of package label
(click image for full-size original)
SANCUSO granisetron patch
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5985(NDC:42747-726)
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GRANISETRON (GRANISETRON) GRANISETRON 3.1 mg in 24 h
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5985-0 1 POUCH (POUCH) in 1 CARTON contains a POUCH
1 1 PATCH (PATCH) in 1 POUCH This package is contained within the CARTON (54868-5985-0) and contains a PATCH
1 168 h in 1 PATCH This package is contained within a POUCH and a CARTON (54868-5985-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022198 02/16/2009
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel

Revised: 09/2009 Physicians Total Care, Inc.

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