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

d918b40d-a461-41bc-b6c0-83dc76c28e32

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 29, 2024

Manufacturers

FDA

Rhodes Pharmaceuticals

DUNS: 831928986

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 Code42858-162

Application NumberANDA215330

Product Classification

Marketing Category

C73584

Generic Name

LISDEXAMFETAMINE DIMESYLATE

Product Specifications

Route of AdministrationORAL

Effective DateOctober 31, 2023

FDA Product Classification

INGREDIENTS (12)

LISDEXAMFETAMINE DIMESYLATEActive

Quantity: 20 mg in 1 1

Code: SJT761GEGS

Classification: ACTIB

MICROCRYSTALLINE CELLULOSE 102Inactive

Code: PNR0YF693Y

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

LISDEXAMFETAMINE DIMESYLATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code42858-164

Application NumberANDA215330

Product Classification

Marketing Category

C73584

Generic Name

LISDEXAMFETAMINE DIMESYLATE

Product Specifications

Route of AdministrationORAL

Effective DateOctober 31, 2023

FDA Product Classification

INGREDIENTS (13)

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

LISDEXAMFETAMINE DIMESYLATEActive

Quantity: 40 mg in 1 1

Code: SJT761GEGS

Classification: ACTIB

MICROCRYSTALLINE CELLULOSE 102Inactive

Code: PNR0YF693Y

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C RED NO. 3Inactive

Code: PN2ZH5LOQY

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

LISDEXAMFETAMINE DIMESYLATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code42858-166

Application NumberANDA215330

Product Classification

Marketing Category

C73584

Generic Name

LISDEXAMFETAMINE DIMESYLATE

Product Specifications

Route of AdministrationORAL

Effective DateOctober 31, 2023

FDA Product Classification

INGREDIENTS (11)

LISDEXAMFETAMINE DIMESYLATEActive

Quantity: 60 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

MICROCRYSTALLINE CELLULOSE 102Inactive

Code: PNR0YF693Y

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

LISDEXAMFETAMINE DIMESYLATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code42858-165

Application NumberANDA215330

Product Classification

Marketing Category

C73584

Generic Name

LISDEXAMFETAMINE DIMESYLATE

Product Specifications

Route of AdministrationORAL

Effective DateOctober 31, 2023

FDA Product Classification

INGREDIENTS (11)

LISDEXAMFETAMINE DIMESYLATEActive

Quantity: 50 mg in 1 1

Code: SJT761GEGS

Classification: ACTIB

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MICROCRYSTALLINE CELLULOSE 102Inactive

Code: PNR0YF693Y

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

LISDEXAMFETAMINE DIMESYLATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code42858-167

Application NumberANDA215330

Product Classification

Marketing Category

C73584

Generic Name

LISDEXAMFETAMINE DIMESYLATE

Product Specifications

Route of AdministrationORAL

Effective DateOctober 31, 2023

FDA Product Classification

INGREDIENTS (13)

LISDEXAMFETAMINE DIMESYLATEActive

Quantity: 70 mg in 1 1

Code: SJT761GEGS

Classification: ACTIB

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MICROCRYSTALLINE CELLULOSE 102Inactive

Code: PNR0YF693Y

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

LISDEXAMFETAMINE DIMESYLATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code42858-163

Application NumberANDA215330

Product Classification

Marketing Category

C73584

Generic Name

LISDEXAMFETAMINE DIMESYLATE

Product Specifications

Route of AdministrationORAL

Effective DateOctober 31, 2023

FDA Product Classification

INGREDIENTS (12)

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

LISDEXAMFETAMINE DIMESYLATEActive

Quantity: 30 mg in 1 1

Code: SJT761GEGS

Classification: ACTIB

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

MICROCRYSTALLINE CELLULOSE 102Inactive

Code: PNR0YF693Y

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

LISDEXAMFETAMINE DIMESYLATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code42858-161

Application NumberANDA215330

Product Classification

Marketing Category

C73584

Generic Name

LISDEXAMFETAMINE DIMESYLATE

Product Specifications

Route of AdministrationORAL

Effective DateOctober 31, 2023

FDA Product Classification

INGREDIENTS (13)

LISDEXAMFETAMINE DIMESYLATEActive

Quantity: 10 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

MICROCRYSTALLINE CELLULOSE 102Inactive

Code: PNR0YF693Y

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NH

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

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LISDEXAMFETAMINE DIMESYLATE

Products 7

LISDEXAMFETAMINE DIMESYLATE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (12)

LISDEXAMFETAMINE DIMESYLATE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

LISDEXAMFETAMINE DIMESYLATE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (11)

LISDEXAMFETAMINE DIMESYLATE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (11)

LISDEXAMFETAMINE DIMESYLATE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

LISDEXAMFETAMINE DIMESYLATE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (12)

LISDEXAMFETAMINE DIMESYLATE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

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