Lisdexamfetamine Dimesylate

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

Approved

Approval ID

2cedb4c2-1e40-4bc4-b9f4-127150c4afbd

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 20, 2023

Manufacturers

FDA

Lannett Company, Inc.

DUNS: 002277481

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 Code0527-4664

Application NumberANDA215802

Product Classification

Marketing Category

C73584

Generic Name

Lisdexamfetamine Dimesylate

Product Specifications

Route of AdministrationORAL

Effective DateOctober 20, 2023

FDA Product Classification

INGREDIENTS (16)

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

MICROCRYSTALLINE CELLULOSE 102Inactive

Code: PNR0YF693Y

Classification: IACT

MICROCRYSTALLINE CELLULOSE 302Inactive

Code: 91B875MM4H

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

D&C YELLOW NO. 10 ALUMINUM LAKEInactive

Code: CQ3XH3DET6

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

FD&C BLUE NO. 2--ALUMINUM LAKEInactive

Code: 4AQJ3LG584

Classification: IACT

LISDEXAMFETAMINE DIMESYLATEActive

Quantity: 40 mg in 1 1

Code: SJT761GEGS

Classification: ACTIB

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

FD&C BLUE NO. 1 ALUMINUM LAKEInactive

Code: J9EQA3S2JM

Classification: IACT

Lisdexamfetamine Dimesylate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0527-4667

Application NumberANDA215802

Product Classification

Marketing Category

C73584

Generic Name

Lisdexamfetamine Dimesylate

Product Specifications

Route of AdministrationORAL

Effective DateOctober 20, 2023

FDA Product Classification

INGREDIENTS (17)

LISDEXAMFETAMINE DIMESYLATEActive

Quantity: 70 mg in 1 1

Code: SJT761GEGS

Classification: ACTIB

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MICROCRYSTALLINE CELLULOSE 302Inactive

Code: 91B875MM4H

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

D&C YELLOW NO. 10 ALUMINUM LAKEInactive

Code: CQ3XH3DET6

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

FD&C BLUE NO. 1 ALUMINUM LAKEInactive

Code: J9EQA3S2JM

Classification: IACT

FD&C BLUE NO. 2--ALUMINUM LAKEInactive

Code: 4AQJ3LG584

Classification: IACT

MICROCRYSTALLINE CELLULOSE 102Inactive

Code: PNR0YF693Y

Classification: IACT

Lisdexamfetamine Dimesylate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0527-4661

Application NumberANDA215802

Product Classification

Marketing Category

C73584

Generic Name

Lisdexamfetamine Dimesylate

Product Specifications

Route of AdministrationORAL

Effective DateOctober 20, 2023

FDA Product Classification

INGREDIENTS (17)

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

LISDEXAMFETAMINE DIMESYLATEActive

Quantity: 10 mg in 1 1

Code: SJT761GEGS

Classification: ACTIB

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MICROCRYSTALLINE CELLULOSE 302Inactive

Code: 91B875MM4H

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

MICROCRYSTALLINE CELLULOSE 102Inactive

Code: PNR0YF693Y

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

FD&C BLUE NO. 2--ALUMINUM LAKEInactive

Code: 4AQJ3LG584

Classification: IACT

D&C YELLOW NO. 10 ALUMINUM LAKEInactive

Code: CQ3XH3DET6

Classification: IACT

FD&C BLUE NO. 1 ALUMINUM LAKEInactive

Code: J9EQA3S2JM

Classification: IACT

Lisdexamfetamine Dimesylate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0527-4663

Application NumberANDA215802

Product Classification

Marketing Category

C73584

Generic Name

Lisdexamfetamine Dimesylate

Product Specifications

Route of AdministrationORAL

Effective DateOctober 20, 2023

FDA Product Classification

INGREDIENTS (16)

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

LISDEXAMFETAMINE DIMESYLATEActive

Quantity: 30 mg in 1 1

Code: SJT761GEGS

Classification: ACTIB

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

MICROCRYSTALLINE CELLULOSE 302Inactive

Code: 91B875MM4H

Classification: IACT

MICROCRYSTALLINE CELLULOSE 102Inactive

Code: PNR0YF693Y

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

D&C YELLOW NO. 10 ALUMINUM LAKEInactive

Code: CQ3XH3DET6

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

FD&C BLUE NO. 1 ALUMINUM LAKEInactive

Code: J9EQA3S2JM

Classification: IACT

FD&C BLUE NO. 2--ALUMINUM LAKEInactive

Code: 4AQJ3LG584

Classification: IACT

Lisdexamfetamine Dimesylate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0527-4666

Application NumberANDA215802

Product Classification

Marketing Category

C73584

Generic Name

Lisdexamfetamine Dimesylate

Product Specifications

Route of AdministrationORAL

Effective DateOctober 20, 2023

FDA Product Classification

INGREDIENTS (17)

LISDEXAMFETAMINE DIMESYLATEActive

Quantity: 60 mg in 1 1

Code: SJT761GEGS

Classification: ACTIB

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

MICROCRYSTALLINE CELLULOSE 302Inactive

Code: 91B875MM4H

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MICROCRYSTALLINE CELLULOSE 102Inactive

Code: PNR0YF693Y

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

FD&C BLUE NO. 2--ALUMINUM LAKEInactive

Code: 4AQJ3LG584

Classification: IACT

D&C YELLOW NO. 10 ALUMINUM LAKEInactive

Code: CQ3XH3DET6

Classification: IACT

FD&C BLUE NO. 1 ALUMINUM LAKEInactive

Code: J9EQA3S2JM

Classification: IACT

Lisdexamfetamine Dimesylate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0527-4665

Application NumberANDA215802

Product Classification

Marketing Category

C73584

Generic Name

Lisdexamfetamine Dimesylate

Product Specifications

Route of AdministrationORAL

Effective DateOctober 20, 2023

FDA Product Classification

INGREDIENTS (16)

FD&C BLUE NO. 1 ALUMINUM LAKEInactive

Code: J9EQA3S2JM

Classification: IACT

D&C YELLOW NO. 10 ALUMINUM LAKEInactive

Code: CQ3XH3DET6

Classification: IACT

LISDEXAMFETAMINE DIMESYLATEActive

Quantity: 50 mg in 1 1

Code: SJT761GEGS

Classification: ACTIB

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MICROCRYSTALLINE CELLULOSE 302Inactive

Code: 91B875MM4H

Classification: IACT

MICROCRYSTALLINE CELLULOSE 102Inactive

Code: PNR0YF693Y

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

FD&C BLUE NO. 2--ALUMINUM LAKEInactive

Code: 4AQJ3LG584

Classification: IACT

Lisdexamfetamine Dimesylate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0527-4662

Application NumberANDA215802

Product Classification

Marketing Category

C73584

Generic Name

Lisdexamfetamine Dimesylate

Product Specifications

Route of AdministrationORAL

Effective DateOctober 20, 2023

FDA Product Classification

INGREDIENTS (17)

LISDEXAMFETAMINE DIMESYLATEActive

Quantity: 20 mg in 1 1

Code: SJT761GEGS

Classification: ACTIB

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

FD&C BLUE NO. 2--ALUMINUM LAKEInactive

Code: 4AQJ3LG584

Classification: IACT

FD&C BLUE NO. 1 ALUMINUM LAKEInactive

Code: J9EQA3S2JM

Classification: IACT

MICROCRYSTALLINE CELLULOSE 302Inactive

Code: 91B875MM4H

Classification: IACT

MICROCRYSTALLINE CELLULOSE 102Inactive

Code: PNR0YF693Y

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

D&C YELLOW NO. 10 ALUMINUM LAKEInactive

Code: CQ3XH3DET6

Classification: IACT

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Lisdexamfetamine Dimesylate

Products 7

Lisdexamfetamine Dimesylate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

Lisdexamfetamine Dimesylate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

Lisdexamfetamine Dimesylate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

Lisdexamfetamine Dimesylate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

Lisdexamfetamine Dimesylate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

Lisdexamfetamine Dimesylate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

Lisdexamfetamine Dimesylate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

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