Lenalidomide
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 2005
Approved
Approval ID
76f6c1e7-985b-43d9-892c-849df50ae80e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 31, 2023
Manufacturers
FDA
Mylan Pharmaceuticals Inc.
DUNS: 059295980
Products 6
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 Code0378-1936
Application NumberANDA213912
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lenalidomide
Product Specifications
Route of AdministrationORAL
Effective DateMay 15, 2022
FDA Product Classification
INGREDIENTS (13)
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
LENALIDOMIDEActive
Quantity: 5 mg in 1 1
Code: F0P408N6V4
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Lenalidomide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-1941
Application NumberANDA213912
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lenalidomide
Product Specifications
Route of AdministrationORAL
Effective DateMay 15, 2022
FDA Product Classification
INGREDIENTS (13)
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
LENALIDOMIDEActive
Quantity: 15 mg in 1 1
Code: F0P408N6V4
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
Lenalidomide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-1940
Application NumberANDA213912
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lenalidomide
Product Specifications
Route of AdministrationORAL
Effective DateMay 15, 2022
FDA Product Classification
INGREDIENTS (13)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LENALIDOMIDEActive
Quantity: 25 mg in 1 1
Code: F0P408N6V4
Classification: ACTIB
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
Lenalidomide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-1935
Application NumberANDA213912
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lenalidomide
Product Specifications
Route of AdministrationORAL
Effective DateMay 15, 2022
FDA Product Classification
INGREDIENTS (15)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LENALIDOMIDEActive
Quantity: 2.5 mg in 1 1
Code: F0P408N6V4
Classification: ACTIB
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
Lenalidomide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-1942
Application NumberANDA213912
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lenalidomide
Product Specifications
Route of AdministrationORAL
Effective DateMay 15, 2022
FDA Product Classification
INGREDIENTS (15)
LENALIDOMIDEActive
Quantity: 20 mg in 1 1
Code: F0P408N6V4
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
Lenalidomide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-1937
Application NumberANDA213912
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lenalidomide
Product Specifications
Route of AdministrationORAL
Effective DateMay 15, 2022
FDA Product Classification
INGREDIENTS (15)
LENALIDOMIDEActive
Quantity: 10 mg in 1 1
Code: F0P408N6V4
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT