ype HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:59572-503
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POMALIDOMIDE (POMALIDOMIDE) POMALIDOMIDE 3.00 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL 75.75 mg
STARCH, CORN 100.80 mg
SODIUM STEARYL FUMARATE 0.45 mg
Product Characteristics
Color GREEN, BLUE Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code POML;3;mg
Contains
Packaging
Item Code Package Description
1 NDC:59572-503-21 21 CAPSULE in 1 BOTTLE
2 NDC:59572-503-00 100 CAPSULE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA204026 02/18/2013
Pomalyst
pomalidomide capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:59572-504
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POMALIDOMIDE (POMALIDOMIDE) POMALIDOMIDE 4.00 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL 101.00 mg
STARCH, CORN 134.40 mg
SODIUM STEARYL FUMARATE 0.60 mg
Product Characteristics
Color BLUE, BLUE Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code POML;4;mg
Contains
Packaging
Item Code Package Description
1 NDC:59572-504-21 21 CAPSULE in 1 BOTTLE
2 NDC:59572-504-00 100 CAPSULE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA204026 02/18/2013
Labeler - Celgene Corporation (174201137)
Registrant - Celgene Corporation (174201137)
Revised: 02/2013
