Dextroamphetamine Sulfate
DEXTROAMPHETAMINE SULFATE TABLETS USP, CII Rx only
Approved
Approval ID
863d66fe-9c38-463a-afa1-552647494c5a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 17, 2024
Manufacturers
FDA
KVK-Tech, Inc.
DUNS: 173360061
Products 2
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 Code10702-065
Application NumberANDA203548
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dextroamphetamine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 17, 2024
FDA Product Classification
INGREDIENTS (6)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
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 Code10702-066
Application NumberANDA203548
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dextroamphetamine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 17, 2024
FDA Product Classification
INGREDIENTS (6)
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DEXTROAMPHETAMINE SULFATEActive
Quantity: 10 mg in 1 1
Code: JJ768O327N
Classification: ACTIB