Lenalidomide

Basic Information

Product Name

Lenalidomide

FDA Product Code

60505-4533

Regulatory Information

NDC Product Code

60505-4533

Application Number

ANDA211022

Marketing Category

C73584

Effective Date

April 15, 2023

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use LENALIDOMIDE CAPSULES safely and effectively. See full prescribing information for LENALIDOMIDE CAPSULES. LENALIDOMIDE capsules, for oral use Initial U.S. Approval: 2005

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

ANHYDROUS LACTOSE

Code: 3SY5LH9PMK

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

LENALIDOMIDE

Quantity: 5 mg in 1 1

Code: F0P408N6V4

Class Code: ACTIB

AMMONIA

Code: 5138Q19F1X

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

GELATIN, UNSPECIFIED

Code: 2G86QN327L

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

Active Moieties

Code: F0P408N6V4

Lenalidomide

Basic Information

Regulatory Information

Company Information

Active Ingredients

ANHYDROUS LACTOSE

CROSCARMELLOSE SODIUM

AMMONIA

MICROCRYSTALLINE CELLULOSE

MAGNESIUM STEARATE

TITANIUM DIOXIDE

GELATIN, UNSPECIFIED

FERROSOFERRIC OXIDE

SHELLAC

PROPYLENE GLYCOL

Active Moieties

Lenalidomide