dextroamphetamine sulfate
Dextroamphetamine Sulfate Tablets, USP, 5 mg and 10 mg
Approved
Approval ID
b2ad8d2b-ed94-43cd-95ea-85e91d997f26
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 7, 2007
Manufacturers
FDA
Ethex Corporation
DUNS: 615424686
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 Code58177-311
Application NumberANDA040365
Product Classification
M
Marketing Category
C73584
G
Generic Name
dextroamphetamine sulfate
Product Specifications
Route of AdministrationORAL
Effective DateApril 7, 2007
FDA Product Classification
INGREDIENTS (10)
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
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 Code58177-312
Application NumberANDA040367
Product Classification
M
Marketing Category
C73584
G
Generic Name
dextroamphetamine sulfate
Product Specifications
Route of AdministrationORAL
Effective DateApril 7, 2007
FDA Product Classification
INGREDIENTS (12)
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
dextroamphetamine sulfateActive
Quantity: 10 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT