Vyvanse
These highlights do not include all the information needed to use VYVANSE safely and effectively. See full prescribing information for VYVANSE. VYVANSE (lisdexamfetamine dimesylate) capsules, for oral use, CII VYVANSE (lisdexamfetamine dimesylate) chewable tablets, for oral use, CII Initial U.S. Approval: 2007
Approved
Approval ID
704e4378-ca83-445c-8b45-3cfa51c1ecad
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 13, 2023
Manufacturers
FDA
Takeda Pharmaceuticals America, Inc.
DUNS: 039997266
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 Code59417-118
Application NumberNDA208510
Product Classification
M
Marketing Category
C73594
G
Generic Name
LISDEXAMFETAMINE DIMESYLATE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2023
FDA Product Classification
INGREDIENTS (8)
LISDEXAMFETAMINE DIMESYLATEActive
Quantity: 40 mg in 1 1
Code: SJT761GEGS
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
GUAR GUMInactive
Code: E89I1637KE
Classification: IACT
lisdexamfetamine dimesylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59417-103
Application NumberNDA021977
Product Classification
M
Marketing Category
C73594
G
Generic Name
lisdexamfetamine dimesylate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2023
FDA Product Classification
INGREDIENTS (8)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
LISDEXAMFETAMINE DIMESYLATEActive
Quantity: 30 mg in 1 1
Code: SJT761GEGS
Classification: ACTIB
LISDEXAMFETAMINE DIMESYLATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59417-115
Application NumberNDA208510
Product Classification
M
Marketing Category
C73594
G
Generic Name
LISDEXAMFETAMINE DIMESYLATE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2023
FDA Product Classification
INGREDIENTS (8)
LISDEXAMFETAMINE DIMESYLATEActive
Quantity: 10 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
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
GUAR GUMInactive
Code: E89I1637KE
Classification: IACT
LISDEXAMFETAMINE DIMESYLATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59417-119
Application NumberNDA208510
Product Classification
M
Marketing Category
C73594
G
Generic Name
LISDEXAMFETAMINE DIMESYLATE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2023
FDA Product Classification
INGREDIENTS (8)
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
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
GUAR GUMInactive
Code: E89I1637KE
Classification: IACT
lisdexamfetamine dimesylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59417-104
Application NumberNDA021977
Product Classification
M
Marketing Category
C73594
G
Generic Name
lisdexamfetamine dimesylate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2023
FDA Product Classification
INGREDIENTS (9)
LISDEXAMFETAMINE DIMESYLATEActive
Quantity: 40 mg in 1 1
Code: SJT761GEGS
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
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 Code59417-105
Application NumberNDA021977
Product Classification
M
Marketing Category
C73594
G
Generic Name
lisdexamfetamine dimesylate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2023
FDA Product Classification
INGREDIENTS (7)
LISDEXAMFETAMINE DIMESYLATEActive
Quantity: 50 mg in 1 1
Code: SJT761GEGS
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
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
lisdexamfetamine dimesylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59417-102
Application NumberNDA021977
Product Classification
M
Marketing Category
C73594
G
Generic Name
lisdexamfetamine dimesylate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2023
FDA Product Classification
INGREDIENTS (7)
LISDEXAMFETAMINE DIMESYLATEActive
Quantity: 20 mg in 1 1
Code: SJT761GEGS
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
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
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LISDEXAMFETAMINE DIMESYLATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59417-116
Application NumberNDA208510
Product Classification
M
Marketing Category
C73594
G
Generic Name
LISDEXAMFETAMINE DIMESYLATE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2023
FDA Product Classification
INGREDIENTS (8)
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
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
GUAR GUMInactive
Code: E89I1637KE
Classification: IACT
lisdexamfetamine dimesylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59417-101
Application NumberNDA021977
Product Classification
M
Marketing Category
C73594
G
Generic Name
lisdexamfetamine dimesylate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2023
FDA Product Classification
INGREDIENTS (7)
LISDEXAMFETAMINE DIMESYLATEActive
Quantity: 10 mg in 1 1
Code: SJT761GEGS
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
LISDEXAMFETAMINE DIMESYLATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59417-117
Application NumberNDA208510
Product Classification
M
Marketing Category
C73594
G
Generic Name
LISDEXAMFETAMINE DIMESYLATE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2023
FDA Product Classification
INGREDIENTS (8)
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
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
GUAR GUMInactive
Code: E89I1637KE
Classification: IACT