Levetiracetam
These highlights do not include all the information needed to use LEVETIRACETAM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM EXTENDED-RELEASE TABLETS.LEVETIRACETAM extended-release tablets, for oral use Initial U.S. Approval: 1999
Approved
Approval ID
02727941-c5ea-4f85-beb4-2a00eec73dd0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 6, 2017
Manufacturers
FDA
IntelliPharmaCeutics Corp.
DUNS: 255128878
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Levetiracetam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code35208-032
Application NumberANDA204511
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levetiracetam
Product Specifications
Route of AdministrationORAL
Effective DateMay 28, 2015
FDA Product Classification
INGREDIENTS (6)
LEVETIRACETAMActive
Quantity: 750 mg in 1 1
Code: 44YRR34555
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
Levetiracetam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code35208-031
Application NumberANDA204511
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levetiracetam
Product Specifications
Route of AdministrationORAL
Effective DateMay 28, 2015
FDA Product Classification
INGREDIENTS (6)
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LEVETIRACETAMActive
Quantity: 500 mg in 1 1
Code: 44YRR34555
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT