LISDEXAMFETAMINE DIMESYLATE

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

Approved

Approval ID

da3148af-f9b6-4725-adae-3595b4c7dc4b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 1, 2023

Manufacturers

FDA

Sun Pharmaceutical Industries, Inc.

DUNS: 146974886

Products 10

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 Code57664-086

Application NumberANDA214134

Product Classification

Marketing Category

C73584

Generic Name

LISDEXAMFETAMINE DIMESYLATE

Product Specifications

Route of AdministrationORAL

Effective DateDecember 1, 2023

FDA Product Classification

INGREDIENTS (11)

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

MALTODEXTRINInactive

Code: 7CVR7L4A2D

Classification: IACT

GUAR GUMInactive

Code: E89I1637KE

Classification: IACT

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive

Code: 461P5CJN6T

Classification: IACT

SUCRALOSEInactive

Code: 96K6UQ3ZD4

Classification: IACT

LISDEXAMFETAMINE DIMESYLATEActive

Quantity: 40 mg in 1 1

Code: SJT761GEGS

Classification: ACTIB

LISDEXAMFETAMINE DIMESYLATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code57664-051

Application NumberANDA214484

Product Classification

Marketing Category

C73584

Generic Name

LISDEXAMFETAMINE DIMESYLATE

Product Specifications

Route of AdministrationORAL

Effective DateDecember 1, 2023

FDA Product Classification

INGREDIENTS (10)

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

LISDEXAMFETAMINE DIMESYLATEActive

Quantity: 60 mg in 1 1

Code: SJT761GEGS

Classification: ACTIB

LISDEXAMFETAMINE DIMESYLATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code57664-050

Application NumberANDA214484

Product Classification

Marketing Category

C73584

Generic Name

LISDEXAMFETAMINE DIMESYLATE

Product Specifications

Route of AdministrationORAL

Effective DateDecember 1, 2023

FDA Product Classification

INGREDIENTS (11)

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NH

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

LISDEXAMFETAMINE DIMESYLATEActive

Quantity: 50 mg in 1 1

Code: SJT761GEGS

Classification: ACTIB

LISDEXAMFETAMINE DIMESYLATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code57664-047

Application NumberANDA214484

Product Classification

Marketing Category

C73584

Generic Name

LISDEXAMFETAMINE DIMESYLATE

Product Specifications

Route of AdministrationORAL

Effective DateDecember 1, 2023

FDA Product Classification

INGREDIENTS (10)

SHELLACInactive

Code: 46N107B71O

Classification: IACT

LISDEXAMFETAMINE DIMESYLATEActive

Quantity: 20 mg in 1 1

Code: SJT761GEGS

Classification: ACTIB

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

LISDEXAMFETAMINE DIMESYLATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code57664-046

Application NumberANDA214484

Product Classification

Marketing Category

C73584

Generic Name

LISDEXAMFETAMINE DIMESYLATE

Product Specifications

Route of AdministrationORAL

Effective DateDecember 1, 2023

FDA Product Classification

INGREDIENTS (10)

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

FD&C RED NO. 3Inactive

Code: PN2ZH5LOQY

Classification: IACT

LISDEXAMFETAMINE DIMESYLATEActive

Quantity: 10 mg in 1 1

Code: SJT761GEGS

Classification: ACTIB

LISDEXAMFETAMINE DIMESYLATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code57664-049

Application NumberANDA214484

Product Classification

Marketing Category

C73584

Generic Name

LISDEXAMFETAMINE DIMESYLATE

Product Specifications

Route of AdministrationORAL

Effective DateDecember 1, 2023

FDA Product Classification

INGREDIENTS (11)

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

LISDEXAMFETAMINE DIMESYLATEActive

Quantity: 40 mg in 1 1

Code: SJT761GEGS

Classification: ACTIB

LISDEXAMFETAMINE DIMESYLATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code57664-088

Application NumberANDA214134

Product Classification

Marketing Category

C73584

Generic Name

LISDEXAMFETAMINE DIMESYLATE

Product Specifications

Route of AdministrationORAL

Effective DateDecember 1, 2023

FDA Product Classification

INGREDIENTS (11)

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

MALTODEXTRINInactive

Code: 7CVR7L4A2D

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

GUAR GUMInactive

Code: E89I1637KE

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive

Code: 461P5CJN6T

Classification: IACT

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

SUCRALOSEInactive

Code: 96K6UQ3ZD4

Classification: IACT

LISDEXAMFETAMINE DIMESYLATEActive

Quantity: 60 mg in 1 1

Code: SJT761GEGS

Classification: ACTIB

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

LISDEXAMFETAMINE DIMESYLATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code57664-087

Application NumberANDA214134

Product Classification

Marketing Category

C73584

Generic Name

LISDEXAMFETAMINE DIMESYLATE

Product Specifications

Route of AdministrationORAL

Effective DateDecember 1, 2023

FDA Product Classification

INGREDIENTS (11)

MALTODEXTRINInactive

Code: 7CVR7L4A2D

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive

Code: 461P5CJN6T

Classification: IACT

GUAR GUMInactive

Code: E89I1637KE

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SUCRALOSEInactive

Code: 96K6UQ3ZD4

Classification: IACT

LISDEXAMFETAMINE DIMESYLATEActive

Quantity: 50 mg in 1 1

Code: SJT761GEGS

Classification: ACTIB

LISDEXAMFETAMINE DIMESYLATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code57664-085

Application NumberANDA214134

Product Classification

Marketing Category

C73584

Generic Name

LISDEXAMFETAMINE DIMESYLATE

Product Specifications

Route of AdministrationORAL

Effective DateDecember 1, 2023

FDA Product Classification

INGREDIENTS (11)

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

MALTODEXTRINInactive

Code: 7CVR7L4A2D

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

GUAR GUMInactive

Code: E89I1637KE

Classification: IACT

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

LISDEXAMFETAMINE DIMESYLATEActive

Quantity: 30 mg in 1 1

Code: SJT761GEGS

Classification: ACTIB

MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive

Code: 461P5CJN6T

Classification: IACT

SUCRALOSEInactive

Code: 96K6UQ3ZD4

Classification: IACT

LISDEXAMFETAMINE DIMESYLATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code57664-048

Application NumberANDA214484

Product Classification

Marketing Category

C73584

Generic Name

LISDEXAMFETAMINE DIMESYLATE

Product Specifications

Route of AdministrationORAL

Effective DateDecember 1, 2023

FDA Product Classification

INGREDIENTS (12)

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

LISDEXAMFETAMINE DIMESYLATEActive

Quantity: 30 mg in 1 1

Code: SJT761GEGS

Classification: ACTIB

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NH

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

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LISDEXAMFETAMINE DIMESYLATE

Products 10

LISDEXAMFETAMINE DIMESYLATE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (11)

LISDEXAMFETAMINE DIMESYLATE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (10)

LISDEXAMFETAMINE DIMESYLATE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (11)

LISDEXAMFETAMINE DIMESYLATE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (10)

LISDEXAMFETAMINE DIMESYLATE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (10)

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 (11)

LISDEXAMFETAMINE DIMESYLATE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (11)

LISDEXAMFETAMINE DIMESYLATE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (12)

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