Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS Rx only
Approved
Approval ID
e677690f-790f-4626-ad78-097cdb6ea540
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 26, 2019
Manufacturers
FDA
Elite Laboratories, Inc.
DUNS: 785398728
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 Code64850-502
Application NumberANDA211352
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 29, 2022
FDA Product Classification
INGREDIENTS (11)
AMPHETAMINE SULFATEActive
Quantity: 2.50 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
DEXTROAMPHETAMINE SULFATEActive
Quantity: 2.50 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
DEXTROAMPHETAMINE SACCHARATEActive
Quantity: 2.50 mg in 1 1
Code: G83415V073
Classification: ACTIB
AMPHETAMINE ASPARTATE MONOHYDRATEActive
Quantity: 2.50 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 Code64850-505
Application NumberANDA211352
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 29, 2022
FDA Product Classification
INGREDIENTS (11)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
DEXTROAMPHETAMINE SULFATEActive
Quantity: 5.00 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
AMPHETAMINE SULFATEActive
Quantity: 5.00 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
DEXTROAMPHETAMINE SACCHARATEActive
Quantity: 5.00 mg in 1 1
Code: G83415V073
Classification: ACTIB
AMPHETAMINE ASPARTATE MONOHYDRATEActive
Quantity: 5.00 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 Code64850-504
Application NumberANDA211352
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 29, 2022
FDA Product Classification
INGREDIENTS (11)
DEXTROAMPHETAMINE SULFATEActive
Quantity: 3.750 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
AMPHETAMINE SULFATEActive
Quantity: 3.750 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
DEXTROAMPHETAMINE SACCHARATEActive
Quantity: 3.750 mg in 1 1
Code: G83415V073
Classification: ACTIB
AMPHETAMINE ASPARTATE MONOHYDRATEActive
Quantity: 3.750 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 Code64850-506
Application NumberANDA211352
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 29, 2022
FDA Product Classification
INGREDIENTS (11)
DEXTROAMPHETAMINE SULFATEActive
Quantity: 7.50 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
AMPHETAMINE SULFATEActive
Quantity: 7.50 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
DEXTROAMPHETAMINE SACCHARATEActive
Quantity: 7.50 mg in 1 1
Code: G83415V073
Classification: ACTIB
AMPHETAMINE ASPARTATE MONOHYDRATEActive
Quantity: 7.50 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 Code64850-501
Application NumberANDA211352
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 29, 2022
FDA Product Classification
INGREDIENTS (11)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
DEXTROAMPHETAMINE SULFATEActive
Quantity: 1.875 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
AMPHETAMINE SULFATEActive
Quantity: 1.875 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
DEXTROAMPHETAMINE SACCHARATEActive
Quantity: 1.875 mg in 1 1
Code: G83415V073
Classification: ACTIB
AMPHETAMINE ASPARTATE MONOHYDRATEActive
Quantity: 1.875 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 Code64850-500
Application NumberANDA211352
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 29, 2022
FDA Product Classification
INGREDIENTS (11)
DEXTROAMPHETAMINE SULFATEActive
Quantity: 1.25 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
AMPHETAMINE SULFATEActive
Quantity: 1.25 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
AMPHETAMINE ASPARTATE MONOHYDRATEActive
Quantity: 1.25 mg in 1 1
Code: O1ZPV620O4
Classification: ACTIB
DEXTROAMPHETAMINE SACCHARATEActive
Quantity: 1.25 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 Code64850-503
Application NumberANDA211352
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 29, 2022
FDA Product Classification
INGREDIENTS (11)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
DEXTROAMPHETAMINE SULFATEActive
Quantity: 3.125 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
AMPHETAMINE SULFATEActive
Quantity: 3.125 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
DEXTROAMPHETAMINE SACCHARATEActive
Quantity: 3.125 mg in 1 1
Code: G83415V073
Classification: ACTIB
AMPHETAMINE ASPARTATE MONOHYDRATEActive
Quantity: 3.125 mg in 1 1
Code: O1ZPV620O4
Classification: ACTIB