Size 9mm
Flavor Imprint Code NVR;SA
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 54868-5289-0 30TABLETIn1BOTTLE None
2 54868-5289-1 10TABLETIn1BOTTLE None
3 54868-5289-2 90TABLETIn1BOTTLE None
4 54868-5289-3 100TABLETIn1BOTTLE None
5 54868-5289-4 60TABLETIn1BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021588 10/07/2005
GLEEVEC
imatinib mesylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 54868-5427(0078-0438)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IMATINIB MESYLATE(IMATINIB) IMATINIB 400mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE
FERRIC OXIDE RED
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
TALC
FERRIC OXIDE YELLOW
HYPROMELLOSE
Product Characteristics
Color yellow (Very dark yellow to brownish orange) Score 2pieces
Shape OVAL (biconvex with bevelled edges) Size 19mm
Flavor Imprint Code 400;SL
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 54868-5427-0 30TABLETIn1BOTTLE None
2 54868-5427-1 15TABLETIn1BOTTLE None
3 54868-5427-2 45TABLETIn1BOTTLE None
4 54868-5427-3 60TABLETIn1BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021588 11/09/2005
Labeler -Physicians Total Care, Inc.(194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 label,repack
