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 use Initial U.S. Approval: 2005

Approved

Approval ID

f27092f3-3977-4f4a-b214-45309e136e46

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 13, 2023

Manufacturers

FDA

Camber Pharmaceuticals, Inc.

DUNS: 826774775

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 Code31722-261

Application NumberANDA212414

Product Classification

Marketing Category

C73584

Generic Name

LENALIDOMIDE

Product Specifications

Route of AdministrationORAL

Effective DateJuly 13, 2023

FDA Product Classification

INGREDIENTS (14)

LENALIDOMIDEActive

Quantity: 20 mg in 1 1

Code: F0P408N6V4

Classification: ACTIB

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMK

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

SHELLACInactive

Code: MB5IUD6JUA

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

LENALIDOMIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code31722-259

Application NumberANDA212414

Product Classification

Marketing Category

C73584

Generic Name

LENALIDOMIDE

Product Specifications

Route of AdministrationORAL

Effective DateJuly 13, 2023

FDA Product Classification

INGREDIENTS (13)

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SHELLACInactive

Code: MB5IUD6JUA

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

LENALIDOMIDEActive

Quantity: 10 mg in 1 1

Code: F0P408N6V4

Classification: ACTIB

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMK

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

LENALIDOMIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code31722-257

Application NumberANDA212414

Product Classification

Marketing Category

C73584

Generic Name

LENALIDOMIDE

Product Specifications

Route of AdministrationORAL

Effective DateJuly 13, 2023

FDA Product Classification

INGREDIENTS (13)

SHELLACInactive

Code: MB5IUD6JUA

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMK

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

LENALIDOMIDEActive

Quantity: 2.5 mg in 1 1

Code: F0P408N6V4

Classification: ACTIB

LENALIDOMIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code31722-258

Application NumberANDA212414

Product Classification

Marketing Category

C73584

Generic Name

LENALIDOMIDE

Product Specifications

Route of AdministrationORAL

Effective DateJuly 13, 2023

FDA Product Classification

INGREDIENTS (12)

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMK

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

SHELLACInactive

Code: MB5IUD6JUA

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

LENALIDOMIDEActive

Quantity: 5 mg in 1 1

Code: F0P408N6V4

Classification: ACTIB

LENALIDOMIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code31722-260

Application NumberANDA212414

Product Classification

Marketing Category

C73584

Generic Name

LENALIDOMIDE

Product Specifications

Route of AdministrationORAL

Effective DateJuly 13, 2023

FDA Product Classification

INGREDIENTS (13)

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMK

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

SHELLACInactive

Code: MB5IUD6JUA

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

LENALIDOMIDEActive

Quantity: 15 mg in 1 1

Code: F0P408N6V4

Classification: ACTIB

LENALIDOMIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code31722-262

Application NumberANDA212414

Product Classification

Marketing Category

C73584

Generic Name

LENALIDOMIDE

Product Specifications

Route of AdministrationORAL

Effective DateJuly 13, 2023

FDA Product Classification

INGREDIENTS (12)

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMK

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

SHELLACInactive

Code: MB5IUD6JUA

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

LENALIDOMIDEActive

Quantity: 25 mg in 1 1

Code: F0P408N6V4

Classification: ACTIB

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LENALIDOMIDE

Products 6

LENALIDOMIDE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

LENALIDOMIDE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

LENALIDOMIDE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

LENALIDOMIDE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (12)

LENALIDOMIDE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

LENALIDOMIDE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (12)

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