lenalidomide
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 useInitial U.S. Approval: 2005
Approved
Approval ID
682e8a86-9f49-45db-a2ea-403ee1dc62d2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 13, 2022
Manufacturers
FDA
Exelan Pharmaceuticals, Inc.
DUNS: 967795266
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
lenalidomide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76282-698
Application NumberANDA210435
Product Classification
M
Marketing Category
C73584
G
Generic Name
lenalidomide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2022
FDA Product Classification
INGREDIENTS (13)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LENALIDOMIDEActive
Quantity: 10 mg in 1 1
Code: F0P408N6V4
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
lenalidomide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76282-697
Application NumberANDA210435
Product Classification
M
Marketing Category
C73584
G
Generic Name
lenalidomide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2022
FDA Product Classification
INGREDIENTS (11)
LENALIDOMIDEActive
Quantity: 5 mg in 1 1
Code: F0P408N6V4
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
lenalidomide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76282-699
Application NumberANDA210435
Product Classification
M
Marketing Category
C73584
G
Generic Name
lenalidomide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2022
FDA Product Classification
INGREDIENTS (12)
LENALIDOMIDEActive
Quantity: 15 mg in 1 1
Code: F0P408N6V4
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
lenalidomide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76282-701
Application NumberANDA210435
Product Classification
M
Marketing Category
C73584
G
Generic Name
lenalidomide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2022
FDA Product Classification
INGREDIENTS (11)
LENALIDOMIDEActive
Quantity: 25 mg in 1 1
Code: F0P408N6V4
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT