LISDEXAMFETAMINE DIMESYLATE

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

Approved

Approval ID

2653e72f-ebde-4245-9462-8b671b5d8a92

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 25, 2023

Manufacturers

FDA

Ascent Pharmaceuticals, Inc

DUNS: 080938961

Products 6

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 Code43602-553

Application NumberANDA217068

Product Classification

Marketing Category

C73584

Generic Name

lisdexamfetamine dimesylate

Product Specifications

Route of AdministrationORAL

Effective DateAugust 29, 2023

FDA Product Classification

INGREDIENTS (14)

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

LISDEXAMFETAMINE DIMESYLATEActive

Quantity: 30 mg in 1 1

Code: SJT761GEGS

Classification: ACTIB

GUAR GUMInactive

Code: E89I1637KE

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

SUCRALOSEInactive

Code: 96K6UQ3ZD4

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

STARCH, TAPIOCAInactive

Code: 24SC3U704I

Classification: IACT

MEDIUM-CHAIN TRIGLYCERIDESInactive

Code: C9H2L21V7U

Classification: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSL

Classification: IACT

MALTODEXTRINInactive

Code: 7CVR7L4A2D

Classification: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EU

Classification: IACT

TARTARIC ACIDInactive

Code: W4888I119H

Classification: IACT

lisdexamfetamine dimesylate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code43602-556

Application NumberANDA217068

Product Classification

Marketing Category

C73584

Generic Name

lisdexamfetamine dimesylate

Product Specifications

Route of AdministrationORAL

Effective DateAugust 29, 2023

FDA Product Classification

INGREDIENTS (14)

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MALTODEXTRINInactive

Code: 7CVR7L4A2D

Classification: IACT

SUCRALOSEInactive

Code: 96K6UQ3ZD4

Classification: IACT

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

STARCH, TAPIOCAInactive

Code: 24SC3U704I

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

MEDIUM-CHAIN TRIGLYCERIDESInactive

Code: C9H2L21V7U

Classification: IACT

TARTARIC ACIDInactive

Code: W4888I119H

Classification: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSL

Classification: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EU

Classification: IACT

LISDEXAMFETAMINE DIMESYLATEActive

Quantity: 60 mg in 1 1

Code: SJT761GEGS

Classification: ACTIB

GUAR GUMInactive

Code: E89I1637KE

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

lisdexamfetamine dimesylate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code43602-551

Application NumberANDA217068

Product Classification

Marketing Category

C73584

Generic Name

lisdexamfetamine dimesylate

Product Specifications

Route of AdministrationORAL

Effective DateAugust 29, 2023

FDA Product Classification

INGREDIENTS (14)

MALTODEXTRINInactive

Code: 7CVR7L4A2D

Classification: IACT

MEDIUM-CHAIN TRIGLYCERIDESInactive

Code: C9H2L21V7U

Classification: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EU

Classification: IACT

LISDEXAMFETAMINE DIMESYLATEActive

Quantity: 10 mg in 1 1

Code: SJT761GEGS

Classification: ACTIB

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

GUAR GUMInactive

Code: E89I1637KE

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

SUCRALOSEInactive

Code: 96K6UQ3ZD4

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

STARCH, TAPIOCAInactive

Code: 24SC3U704I

Classification: IACT

TARTARIC ACIDInactive

Code: W4888I119H

Classification: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSL

Classification: IACT

lisdexamfetamine dimesylate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code43602-554

Application NumberANDA217068

Product Classification

Marketing Category

C73584

Generic Name

lisdexamfetamine dimesylate

Product Specifications

Route of AdministrationORAL

Effective DateAugust 29, 2023

FDA Product Classification

INGREDIENTS (14)

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

LISDEXAMFETAMINE DIMESYLATEActive

Quantity: 40 mg in 1 1

Code: SJT761GEGS

Classification: ACTIB

GUAR GUMInactive

Code: E89I1637KE

Classification: IACT

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

SUCRALOSEInactive

Code: 96K6UQ3ZD4

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EU

Classification: IACT

MALTODEXTRINInactive

Code: 7CVR7L4A2D

Classification: IACT

STARCH, TAPIOCAInactive

Code: 24SC3U704I

Classification: IACT

MEDIUM-CHAIN TRIGLYCERIDESInactive

Code: C9H2L21V7U

Classification: IACT

TARTARIC ACIDInactive

Code: W4888I119H

Classification: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSL

Classification: IACT

lisdexamfetamine dimesylate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code43602-552

Application NumberANDA217068

Product Classification

Marketing Category

C73584

Generic Name

lisdexamfetamine dimesylate

Product Specifications

Route of AdministrationORAL

Effective DateAugust 29, 2023

FDA Product Classification

INGREDIENTS (14)

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

SUCRALOSEInactive

Code: 96K6UQ3ZD4

Classification: IACT

MALTODEXTRINInactive

Code: 7CVR7L4A2D

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

STARCH, TAPIOCAInactive

Code: 24SC3U704I

Classification: IACT

LISDEXAMFETAMINE DIMESYLATEActive

Quantity: 20 mg in 1 1

Code: SJT761GEGS

Classification: ACTIB

GUAR GUMInactive

Code: E89I1637KE

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MEDIUM-CHAIN TRIGLYCERIDESInactive

Code: C9H2L21V7U

Classification: IACT

TARTARIC ACIDInactive

Code: W4888I119H

Classification: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EU

Classification: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSL

Classification: IACT

lisdexamfetamine dimesylate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code43602-555

Application NumberANDA217068

Product Classification

Marketing Category

C73584

Generic Name

lisdexamfetamine dimesylate

Product Specifications

Route of AdministrationORAL

Effective DateAugust 29, 2023

FDA Product Classification

INGREDIENTS (14)

LISDEXAMFETAMINE DIMESYLATEActive

Quantity: 50 mg in 1 1

Code: SJT761GEGS

Classification: ACTIB

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

GUAR GUMInactive

Code: E89I1637KE

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

SUCRALOSEInactive

Code: 96K6UQ3ZD4

Classification: IACT

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

STARCH, TAPIOCAInactive

Code: 24SC3U704I

Classification: IACT

MEDIUM-CHAIN TRIGLYCERIDESInactive

Code: C9H2L21V7U

Classification: IACT

MALTODEXTRINInactive

Code: 7CVR7L4A2D

Classification: IACT

TARTARIC ACIDInactive

Code: W4888I119H

Classification: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EU

Classification: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSL

Classification: IACT

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LISDEXAMFETAMINE DIMESYLATE

Products 6

lisdexamfetamine dimesylate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

lisdexamfetamine dimesylate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

lisdexamfetamine dimesylate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

lisdexamfetamine dimesylate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

lisdexamfetamine dimesylate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

lisdexamfetamine dimesylate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

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