not prescribed. Do not give REVLIMID to other people, even if they have the same symptoms you have. It may harm them and may cause birth defects. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about REVLIMID that is written for health professionals.
What are the ingredients in REVLIMID?
Active ingredient: lenalidomide
Inactive ingredients: lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate.
The 5 mg and 25 mg capsule shell contains gelatin, titanium dioxide and black ink.
The 2.5 and 10 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide and black ink.
The 15 mg capsule shell contains gelatin, FD&C blue #2, titanium dioxide and black ink.
The 20 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide and black ink.
Manufactured for: Celgene Corporation, Summit, NJ 07901
REVLIMID®, REVLIMID REMS®, and THALOMID® are registered trademarks of Celgene Corporation.
Pat. http://www.celgene.com/therapies © 2005-2017 Celgene Corporation All rights reserved. REVPlyMG.021 02/2017
For more information, call 1-888-423-5436 or go to www.CelgeneRiskManagement.com.
PRINCIPAL DISPLAY PANEL
Revlimid (lenalidomide) Capsules, 2.5 mg - 28 Count Bottle
2.5 mg - 28 Count Bottle
PRINCIPAL DISPLAY PANEL
Revlimid (lenalidomide) Capsules, 5 mg - 28 Count Bottle
5 mg - 28 Count Bottle
PRINCIPAL DISPLAY PANEL
Revlimid (lenalidomide) Capsules, 10 mg - 28 Count Bottle
10 mg - 28 Count Bottle
PRINCIPAL DISPLAY PANEL
Revlimid (lenalidomide) Capsules, 15 mg - 21 Count Bottle
15 mg - 21 Count Bottle
PRINCIPAL DISPLAY PANEL
Revlimid (lenalidomide) Capsules, 20 mg - 21 Count Bottle
20 mg - 21 Count Bottle
PRINCIPAL DISPLAY PANEL
Revlimid (lenalidomide) Capsules, 25 mg - 21 Count Bottle
25 mg - 21 Count Bottle
INGREDIENTS AND APPEARANCE
REVLIMID
lenalidomide capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59572-402
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
LENALIDOMIDE (UNII: F0P408N6V4) (LENALIDOMIDE - UNII:F0P408N6V4) LENALIDOMIDE 2.5 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 GREEN, WHITE Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code REV;2;5;mg
Contains
Packaging
Item Code
Package Description
Marketing Start Date
Marketing End Date
1
NDC:59572-402-28 28 in 1 BOTTLE; Type 0: Not a Combination Product 05/09/2012
2
NDC:59572-402-00 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/09/2012
Marketing Information
Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
NDA NDA021880 04/16/2012