DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE
Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets CII Rx only
Approved
Approval ID
6cc3d53e-e5f4-42bb-93f3-5e10bc227ebc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 28, 2021
Manufacturers
FDA
Ascent Pharmaceuticals, Inc
DUNS: 080938961
Products 7
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43602-376
Application NumberANDA213709
Product Classification
M
Marketing Category
C73584
G
Generic Name
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate
Product Specifications
Route of AdministrationORAL
Effective DateApril 28, 2021
FDA Product Classification
INGREDIENTS (12)
DEXTROAMPHETAMINE SULFATEActive
Quantity: 30 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
AMPHETAMINE SULFATEActive
Quantity: 30 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
DEXTROAMPHETAMINE SACCHARATEActive
Quantity: 30 mg in 1 1
Code: G83415V073
Classification: ACTIB
AMPHETAMINE ASPARTATE MONOHYDRATEActive
Quantity: 30 mg in 1 1
Code: O1ZPV620O4
Classification: ACTIB
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43602-375
Application NumberANDA213709
Product Classification
M
Marketing Category
C73584
G
Generic Name
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate
Product Specifications
Route of AdministrationORAL
Effective DateApril 28, 2021
FDA Product Classification
INGREDIENTS (12)
AMPHETAMINE SULFATEActive
Quantity: 20 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
DEXTROAMPHETAMINE SULFATEActive
Quantity: 20 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
AMPHETAMINE ASPARTATE MONOHYDRATEActive
Quantity: 20 mg in 1 1
Code: O1ZPV620O4
Classification: ACTIB
DEXTROAMPHETAMINE SACCHARATEActive
Quantity: 20 mg in 1 1
Code: G83415V073
Classification: ACTIB
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43602-374
Application NumberANDA213709
Product Classification
M
Marketing Category
C73584
G
Generic Name
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate
Product Specifications
Route of AdministrationORAL
Effective DateApril 28, 2021
FDA Product Classification
INGREDIENTS (12)
AMPHETAMINE SULFATEActive
Quantity: 15 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
DEXTROAMPHETAMINE SULFATEActive
Quantity: 15 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
AMPHETAMINE ASPARTATE MONOHYDRATEActive
Quantity: 15 mg in 1 1
Code: O1ZPV620O4
Classification: ACTIB
DEXTROAMPHETAMINE SACCHARATEActive
Quantity: 15 mg in 1 1
Code: G83415V073
Classification: ACTIB
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43602-373
Application NumberANDA213709
Product Classification
M
Marketing Category
C73584
G
Generic Name
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate
Product Specifications
Route of AdministrationORAL
Effective DateApril 28, 2021
FDA Product Classification
INGREDIENTS (12)
AMPHETAMINE SULFATEActive
Quantity: 12.5 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
DEXTROAMPHETAMINE SULFATEActive
Quantity: 12.5 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
AMPHETAMINE ASPARTATE MONOHYDRATEActive
Quantity: 12.5 mg in 1 1
Code: O1ZPV620O4
Classification: ACTIB
DEXTROAMPHETAMINE SACCHARATEActive
Quantity: 12.5 mg in 1 1
Code: G83415V073
Classification: ACTIB
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43602-370
Application NumberANDA213709
Product Classification
M
Marketing Category
C73584
G
Generic Name
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate
Product Specifications
Route of AdministrationORAL
Effective DateApril 28, 2021
FDA Product Classification
INGREDIENTS (11)
AMPHETAMINE SULFATEActive
Quantity: 5 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
DEXTROAMPHETAMINE SULFATEActive
Quantity: 5 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
AMPHETAMINE ASPARTATE MONOHYDRATEActive
Quantity: 5 mg in 1 1
Code: O1ZPV620O4
Classification: ACTIB
DEXTROAMPHETAMINE SACCHARATEActive
Quantity: 5 mg in 1 1
Code: G83415V073
Classification: ACTIB
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43602-372
Application NumberANDA213709
Product Classification
M
Marketing Category
C73584
G
Generic Name
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate
Product Specifications
Route of AdministrationORAL
Effective DateApril 28, 2021
FDA Product Classification
INGREDIENTS (12)
AMPHETAMINE SULFATEActive
Quantity: 10 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
DEXTROAMPHETAMINE SULFATEActive
Quantity: 10 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
DEXTROAMPHETAMINE SACCHARATEActive
Quantity: 10 mg in 1 1
Code: G83415V073
Classification: ACTIB
AMPHETAMINE ASPARTATE MONOHYDRATEActive
Quantity: 10 mg in 1 1
Code: O1ZPV620O4
Classification: ACTIB
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43602-371
Application NumberANDA213709
Product Classification
M
Marketing Category
C73584
G
Generic Name
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate
Product Specifications
Route of AdministrationORAL
Effective DateApril 28, 2021
FDA Product Classification
INGREDIENTS (12)
AMPHETAMINE SULFATEActive
Quantity: 7.5 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
DEXTROAMPHETAMINE SULFATEActive
Quantity: 7.5 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
AMPHETAMINE ASPARTATE MONOHYDRATEActive
Quantity: 7.5 mg in 1 1
Code: O1ZPV620O4
Classification: ACTIB
DEXTROAMPHETAMINE SACCHARATEActive
Quantity: 7.5 mg in 1 1
Code: G83415V073
Classification: ACTIB