Levetiracetam
These highlights do not include all the information needed to use LEVETIRACETAM INJECTION safely and effectively. See full prescribing information for LEVETIRACETAM INJECTION. LEVETIRACETAM injection, for intravenous use Initial U.S. Approval: 1999
Approved
Approval ID
72f7ddd9-1b2c-4e26-8060-20e10c1c5d1c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 17, 2021
Manufacturers
FDA
TAGI Pharma, Inc.
DUNS: 963322560
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 Code51224-013
Application NumberANDA209781
Product Classification
M
Marketing Category
C73584
G
Generic Name
levetiracetam
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 26, 2021
FDA Product Classification
INGREDIENTS (5)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
LEVETIRACETAMActive
Quantity: 100 mg in 1 mL
Code: 44YRR34555
Classification: ACTIB