SPRYCEL (Page 9 of 9)


NDC 54868-5759-0

60 tablets

image of 70 mg package label
(click image for full-size original)

70 mg
Rx only
Do not crush or cut tablet

SPRYCEL dasatinib tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5759(NDC:0003-0524)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
dasatinib (dasatinib) dasatinib 70 mg
Inactive Ingredients
Ingredient Name Strength
croscarmellose sodium
hydroxypropyl cellulose
polyethylene glycols
lactose monohydrate
cellulose, microcrystalline
hydroxypropyl cellulose
magnesium stearate
titanium dioxide
Product Characteristics
Color WHITE Score no score
Shape ROUND (biconvex) Size 9mm
Flavor Imprint Code BMS;524
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5759-0 1 BOTTLE (BOTTLE) in 1 CARTON contains a BOTTLE
1 60 TABLET (TABLET) in 1 BOTTLE This package is contained within the CARTON (54868-5759-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021986 02/12/2007
Labeler — Physicians Total Care, Inc. (194123980)
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel

Revised: 06/2012 Physicians Total Care, Inc.

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