REVLIMID
lenalidomide capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59572-405
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
LENALIDOMIDE (UNII: F0P408N6V4) (LENALIDOMIDE - UNII:F0P408N6V4) LENALIDOMIDE 5 mg
Inactive Ingredients
Ingredient Name
Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code REV;5;mg
Contains
Packaging
Item Code
Package Description
Marketing Start Date
Marketing End Date
1
NDC:59572-405-28 28 in 1 BOTTLE; Type 0: Not a Combination Product 03/03/2009
2
NDC:59572-405-00 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/27/2005
Marketing Information
Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
NDA NDA021880 12/27/2005
REVLIMID
lenalidomide capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59572-410
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
LENALIDOMIDE (UNII: F0P408N6V4) (LENALIDOMIDE - UNII:F0P408N6V4) LENALIDOMIDE 10 mg
Inactive Ingredients
Ingredient Name
Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
Product Characteristics
Color GREEN, YELLOW Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code REV;10;mg
Contains
Packaging
Item Code
Package Description
Marketing Start Date
Marketing End Date
1
NDC:59572-410-28 28 in 1 BOTTLE; Type 0: Not a Combination Product 03/03/2009
2
NDC:59572-410-00 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/27/2005
Marketing Information
Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
NDA NDA021880 12/27/2005
REVLIMID
lenalidomide capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59572-415
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
LENALIDOMIDE (UNII: F0P408N6V4) (LENALIDOMIDE - UNII:F0P408N6V4) LENALIDOMIDE 15 mg
Inactive Ingredients
Ingredient Name
Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
Product Characteristics
Color BLUE, WHITE Scor
