Dextroamphetamine Sulfate
DEXTROAMPHETAMINE SULFATE TABLETS USP, CII
Approved
Approval ID
ca1a8890-0675-4c9c-9716-6c28f975d827
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 21, 2022
Manufacturers
FDA
Winder Laboratories LLC
DUNS: 965195170
Products 7
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dextroamphetamine Sulfate
PRODUCT DETAILS
NDC Product Code75826-121
Application NumberANDA212160
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMarch 21, 2022
Generic NameDextroamphetamine Sulfate
INGREDIENTS (7)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
DEXTROAMPHETAMINE SULFATEActive
Quantity: 5 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
Dextroamphetamine Sulfate
PRODUCT DETAILS
NDC Product Code75826-125
Application NumberANDA212160
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMarch 21, 2022
Generic NameDextroamphetamine Sulfate
INGREDIENTS (7)
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
DEXTROAMPHETAMINE SULFATEActive
Quantity: 20 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
Dextroamphetamine Sulfate
PRODUCT DETAILS
NDC Product Code75826-123
Application NumberANDA212160
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMarch 21, 2022
Generic NameDextroamphetamine Sulfate
INGREDIENTS (8)
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
DEXTROAMPHETAMINE SULFATEActive
Quantity: 10 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
Dextroamphetamine Sulfate
PRODUCT DETAILS
NDC Product Code75826-120
Application NumberANDA212160
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMarch 21, 2022
Generic NameDextroamphetamine Sulfate
INGREDIENTS (5)
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
DEXTROAMPHETAMINE SULFATEActive
Quantity: 2.5 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
Dextroamphetamine Sulfate
PRODUCT DETAILS
NDC Product Code75826-126
Application NumberANDA212160
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMarch 21, 2022
Generic NameDextroamphetamine Sulfate
INGREDIENTS (6)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
DEXTROAMPHETAMINE SULFATEActive
Quantity: 30 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
Dextroamphetamine Sulfate
PRODUCT DETAILS
NDC Product Code75826-124
Application NumberANDA212160
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMarch 21, 2022
Generic NameDextroamphetamine Sulfate
INGREDIENTS (8)
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
DEXTROAMPHETAMINE SULFATEActive
Quantity: 15 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
Dextroamphetamine Sulfate
PRODUCT DETAILS
NDC Product Code75826-122
Application NumberANDA212160
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMarch 21, 2022
Generic NameDextroamphetamine Sulfate
INGREDIENTS (7)
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DEXTROAMPHETAMINE SULFATEActive
Quantity: 7.5 mg in 1 1
Code: JJ768O327N
Classification: ACTIB