Packaging

Item Code

Package Description

Marketing Start Date

Marketing End Date

1
NDC:59572-415-21 21 in 1 BOTTLE; Type 0: Not a Combination Product 07/07/2006 

2
NDC:59572-415-00 100 in 1 BOTTLE; Type 0: Not a Combination Product 07/07/2006 

Marketing Information

Marketing Category

Application Number or Monograph Citation

Marketing Start Date

Marketing End Date

NDA NDA021880 06/29/2006 

REVLIMID 
lenalidomide capsule

Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59572-420
Route of Administration ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Strength

LENALIDOMIDE (UNII: F0P408N6V4) (LENALIDOMIDE - UNII:F0P408N6V4) LENALIDOMIDE 20 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, BLUE Score no score
Shape CAPSULE Size 22mm
Flavor  Imprint Code REV;20;mg
Contains     
 

Packaging

Item Code

Package Description

Marketing Start Date

Marketing End Date

1
NDC:59572-420-21 21 in 1 BOTTLE; Type 0: Not a Combination Product 06/10/2013 

2
NDC:59572-420-00 100 in 1 BOTTLE; Type 0: Not a Combination Product 06/10/2013 
 
Marketing Information

Marketing Category

Application Number or Monograph Citation

Marketing Start Date

Marketing End Date

NDA NDA021880 06/06/2013 
 
REVLIMID 
lenalidomide capsule

Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59572-425
Route of Administration ORAL
 

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Strength

LENALIDOMIDE (UNII: F0P408N6V4) (LENALIDOMIDE - UNII:F0P408N6V4) LENALIDOMIDE 25 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 22mm
Flavor  Imprint Code REV;25;mg
Contains     

Packaging

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1
NDC:59572-425-21 21 in 1 BOTTLE; Type 0: Not a Combination Product 03/03/2009 

2
NDC:59572-425-00 100 in 1 BOTTLE; Type 0: Not a Combination Product 07/07/2006 
 
Marketing Information

Marketing Category

Application Number or Monograph Citation

Marketing Start Date

Marketing End Date

NDA NDA021880 06/29/2006