Amphetamine Sulfate
Amphetamine Sulfate Tablets, USP CII
Approved
Approval ID
432db708-91b7-4802-88c3-ceef597b91da
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 26, 2023
Manufacturers
FDA
Epic Pharma LLC
DUNS: 827915443
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Amphetamine Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42806-029
Application NumberANDA213980
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amphetamine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateJune 6, 2023
FDA Product Classification
INGREDIENTS (5)
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
AMPHETAMINE SULFATEActive
Quantity: 5 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
Amphetamine Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42806-030
Application NumberANDA213980
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amphetamine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateJune 6, 2023
FDA Product Classification
INGREDIENTS (6)
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
AMPHETAMINE SULFATEActive
Quantity: 10 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT