DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Amphetamine Product) CII
Approved
Approval ID
ac102599-3a5b-4154-899e-6ff262be7ff7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 16, 2023
Manufacturers
FDA
SUNRISE PHARMACEUTICAL, INC.
DUNS: 168522378
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 Code11534-190
Application NumberANDA209799
Product Classification
M
Marketing Category
C73584
G
Generic Name
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate
Product Specifications
Route of AdministrationORAL
Effective DateJuly 24, 2017
FDA Product Classification
INGREDIENTS (9)
DEXTROAMPHETAMINE SULFATEActive
Quantity: 1.25 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
AMPHETAMINE SULFATEActive
Quantity: 1.25 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
DEXTROAMPHETAMINE SACCHARATEActive
Quantity: 1.25 mg in 1 1
Code: G83415V073
Classification: ACTIB
AMPHETAMINE ASPARTATE MONOHYDRATEActive
Quantity: 1.25 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 Code11534-194
Application NumberANDA209799
Product Classification
M
Marketing Category
C73584
G
Generic Name
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate
Product Specifications
Route of AdministrationORAL
Effective DateJuly 24, 2017
FDA Product Classification
INGREDIENTS (9)
DEXTROAMPHETAMINE SULFATEActive
Quantity: 3.75 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
AMPHETAMINE SULFATEActive
Quantity: 3.75 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
DEXTROAMPHETAMINE SACCHARATEActive
Quantity: 3.75 mg in 1 1
Code: G83415V073
Classification: ACTIB
AMPHETAMINE ASPARTATE MONOHYDRATEActive
Quantity: 3.75 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 Code11534-191
Application NumberANDA209799
Product Classification
M
Marketing Category
C73584
G
Generic Name
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate
Product Specifications
Route of AdministrationORAL
Effective DateJuly 24, 2017
FDA Product Classification
INGREDIENTS (9)
AMPHETAMINE SULFATEActive
Quantity: 1.875 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
DEXTROAMPHETAMINE SULFATEActive
Quantity: 1.875 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
AMPHETAMINE ASPARTATE MONOHYDRATEActive
Quantity: 1.875 mg in 1 1
Code: O1ZPV620O4
Classification: ACTIB
DEXTROAMPHETAMINE SACCHARATEActive
Quantity: 1.875 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 Code11534-192
Application NumberANDA209799
Product Classification
M
Marketing Category
C73584
G
Generic Name
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate
Product Specifications
Route of AdministrationORAL
Effective DateJuly 24, 2017
FDA Product Classification
INGREDIENTS (9)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DEXTROAMPHETAMINE SULFATEActive
Quantity: 2.5 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
AMPHETAMINE SULFATEActive
Quantity: 2.5 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
DEXTROAMPHETAMINE SACCHARATEActive
Quantity: 2.5 mg in 1 1
Code: G83415V073
Classification: ACTIB
AMPHETAMINE ASPARTATE MONOHYDRATEActive
Quantity: 2.5 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 Code11534-196
Application NumberANDA209799
Product Classification
M
Marketing Category
C73584
G
Generic Name
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate
Product Specifications
Route of AdministrationORAL
Effective DateJuly 24, 2017
FDA Product Classification
INGREDIENTS (9)
DEXTROAMPHETAMINE SULFATEActive
Quantity: 7.5 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
AMPHETAMINE SULFATEActive
Quantity: 7.5 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
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
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code11534-195
Application NumberANDA209799
Product Classification
M
Marketing Category
C73584
G
Generic Name
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate
Product Specifications
Route of AdministrationORAL
Effective DateJuly 24, 2017
FDA Product Classification
INGREDIENTS (9)
DEXTROAMPHETAMINE SULFATEActive
Quantity: 5 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
AMPHETAMINE SULFATEActive
Quantity: 5 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
DEXTROAMPHETAMINE SACCHARATEActive
Quantity: 5 mg in 1 1
Code: G83415V073
Classification: ACTIB
AMPHETAMINE ASPARTATE MONOHYDRATEActive
Quantity: 5 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 Code11534-193
Application NumberANDA209799
Product Classification
M
Marketing Category
C73584
G
Generic Name
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate
Product Specifications
Route of AdministrationORAL
Effective DateJuly 24, 2017
FDA Product Classification
INGREDIENTS (9)
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
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
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