Lisdexamfetamine Dimesylate

These highlights do not include all the information needed to use LISDEXAMFETAMINE DIMESYLATE CAPSULES safely and effectively. See full prescribing information for LISDEXAMFETAMINE DIMESYLATE CAPSULES. LISDEXAMFETAMINE DIMESYLATE capsules, for oral use, CII Initial U.S. Approval: 2007

Approved

Approval ID

806a1c15-0842-4787-b2ad-09a21fd96b37

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 24, 2022

Manufacturers

FDA

SpecGx LLC

DUNS: 080679498

Products 7

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Lisdexamfetamine Dimesylate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0406-5115

Application NumberANDA211840

Product Classification

Marketing Category

C73584

Generic Name

Lisdexamfetamine Dimesylate

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 24, 2022

FDA Product Classification

INGREDIENTS (13)

SHELLACInactive

Code: 46N107B71O

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

LISDEXAMFETAMINE DIMESYLATEActive

Quantity: 50 mg in 1 1

Code: SJT761GEGS

Classification: ACTIB

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

Lisdexamfetamine Dimesylate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0406-5112

Application NumberANDA211840

Product Classification

Marketing Category

C73584

Generic Name

Lisdexamfetamine Dimesylate

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 24, 2022

FDA Product Classification

INGREDIENTS (13)

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

LISDEXAMFETAMINE DIMESYLATEActive

Quantity: 20 mg in 1 1

Code: SJT761GEGS

Classification: ACTIB

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

Lisdexamfetamine Dimesylate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0406-5111

Application NumberANDA211840

Product Classification

Marketing Category

C73584

Generic Name

Lisdexamfetamine Dimesylate

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 24, 2022

FDA Product Classification

INGREDIENTS (14)

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

LISDEXAMFETAMINE DIMESYLATEActive

Quantity: 10 mg in 1 1

Code: SJT761GEGS

Classification: ACTIB

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

FD&C RED NO. 3Inactive

Code: PN2ZH5LOQY

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

Lisdexamfetamine Dimesylate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0406-5116

Application NumberANDA211840

Product Classification

Marketing Category

C73584

Generic Name

Lisdexamfetamine Dimesylate

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 24, 2022

FDA Product Classification

INGREDIENTS (13)

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

LISDEXAMFETAMINE DIMESYLATEActive

Quantity: 60 mg in 1 1

Code: SJT761GEGS

Classification: ACTIB

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

Lisdexamfetamine Dimesylate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0406-5114

Application NumberANDA211840

Product Classification

Marketing Category

C73584

Generic Name

Lisdexamfetamine Dimesylate

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 24, 2022

FDA Product Classification

INGREDIENTS (14)

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

LISDEXAMFETAMINE DIMESYLATEActive

Quantity: 40 mg in 1 1

Code: SJT761GEGS

Classification: ACTIB

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

Lisdexamfetamine Dimesylate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0406-5117

Application NumberANDA211840

Product Classification

Marketing Category

C73584

Generic Name

Lisdexamfetamine Dimesylate

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 24, 2022

FDA Product Classification

INGREDIENTS (15)

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

LISDEXAMFETAMINE DIMESYLATEActive

Quantity: 70 mg in 1 1

Code: SJT761GEGS

Classification: ACTIB

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

FD&C RED NO. 3Inactive

Code: PN2ZH5LOQY

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

Lisdexamfetamine Dimesylate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0406-5113

Application NumberANDA211840

Product Classification

Marketing Category

C73584

Generic Name

Lisdexamfetamine Dimesylate

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 24, 2022

FDA Product Classification

INGREDIENTS (14)

LISDEXAMFETAMINE DIMESYLATEActive

Quantity: 30 mg in 1 1

Code: SJT761GEGS

Classification: ACTIB

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

FD&C RED NO. 3Inactive

Code: PN2ZH5LOQY

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

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Lisdexamfetamine Dimesylate

Products 7

Lisdexamfetamine Dimesylate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

Lisdexamfetamine Dimesylate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

Lisdexamfetamine Dimesylate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

Lisdexamfetamine Dimesylate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

Lisdexamfetamine Dimesylate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

Lisdexamfetamine Dimesylate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

Lisdexamfetamine Dimesylate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

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