Levetiracetam
These highlights do not include all the information needed to use LEVETIRACETAM safely and effectively. See full prescribing information for LEVETIRACETAM. Levetiracetam Injection for intravenous use. Initial U.S. Approval : 1999
Approved
Approval ID
a92107d6-5006-4f6a-ace8-6e18ab14677c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 9, 2011
Manufacturers
FDA
Nexus Pharmaceuticals Inc
DUNS: 620714787
Products 1
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 Code14789-400
Application NumberANDA090813
Product Classification
M
Marketing Category
C73584
G
Generic Name
LEVETIRACETAM
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 7, 2010
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
LEVETIRACETAMActive
Quantity: 100 mg in 1 mL
Code: 44YRR34555
Classification: ACTIM
SODIUM ACETATEInactive
Quantity: 1.6 mg in 1 mL
Code: 4550K0SC9B
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT