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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code75826-121
Application NumberANDA212160
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dextroamphetamine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 21, 2022
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code75826-125
Application NumberANDA212160
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dextroamphetamine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 21, 2022
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code75826-123
Application NumberANDA212160
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dextroamphetamine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 21, 2022
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code75826-120
Application NumberANDA212160
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dextroamphetamine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 21, 2022
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code75826-126
Application NumberANDA212160
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dextroamphetamine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 21, 2022
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code75826-124
Application NumberANDA212160
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dextroamphetamine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 21, 2022
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code75826-122
Application NumberANDA212160
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dextroamphetamine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 21, 2022
FDA Product Classification
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