LENALIDOMIDE

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

Approved

Approval ID

adee5af1-c9ab-c0c7-e400-dea7d2a0d4be

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 6, 2023

Manufacturers

FDA

Alvogen, Inc.

DUNS: 008057330

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 Code47781-488

Application NumberANDA210480

Product Classification

Marketing Category

C73584

Generic Name

Lenalidomide

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 12, 2019

FDA Product Classification

INGREDIENTS (10)

LENALIDOMIDEActive

Quantity: 25 mg in 1 1

Code: F0P408N6V4

Classification: ACTIB

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMK

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

Lenalidomide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code47781-485

Application NumberANDA210480

Product Classification

Marketing Category

C73584

Generic Name

Lenalidomide

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 12, 2019

FDA Product Classification

INGREDIENTS (14)

LENALIDOMIDEActive

Quantity: 10 mg in 1 1

Code: F0P408N6V4

Classification: ACTIB

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMK

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

FD&C YELLOW NO. 5Inactive

Code: I753WB2F1M

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

Lenalidomide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code47781-484

Application NumberANDA210480

Product Classification

Marketing Category

C73584

Generic Name

Lenalidomide

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 12, 2019

FDA Product Classification

INGREDIENTS (14)

LENALIDOMIDEActive

Quantity: 5 mg in 1 1

Code: F0P408N6V4

Classification: ACTIB

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMK

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

Lenalidomide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code47781-483

Application NumberANDA210480

Product Classification

Marketing Category

C73584

Generic Name

Lenalidomide

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 12, 2019

FDA Product Classification

INGREDIENTS (15)

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

LENALIDOMIDEActive

Quantity: 2.5 mg in 1 1

Code: F0P408N6V4

Classification: ACTIB

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMK

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

FD&C RED NO. 3Inactive

Code: PN2ZH5LOQY

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

Lenalidomide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code47781-487

Application NumberANDA210480

Product Classification

Marketing Category

C73584

Generic Name

Lenalidomide

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 12, 2019

FDA Product Classification

INGREDIENTS (14)

LENALIDOMIDEActive

Quantity: 20 mg in 1 1

Code: F0P408N6V4

Classification: ACTIB

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMK

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

Lenalidomide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code47781-486

Application NumberANDA210480

Product Classification

Marketing Category

C73584

Generic Name

Lenalidomide

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 12, 2019

FDA Product Classification

INGREDIENTS (15)

LENALIDOMIDEActive

Quantity: 15 mg in 1 1

Code: F0P408N6V4

Classification: ACTIB

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMK

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C YELLOW NO. 5Inactive

Code: I753WB2F1M

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

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LENALIDOMIDE

Products 6

Lenalidomide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (10)

Lenalidomide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

Lenalidomide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

Lenalidomide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

Lenalidomide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

Lenalidomide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

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