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 useInitial U.S. Approval: 1999
Approved
Approval ID
f00d8f59-c333-48ad-aca3-98a49bcd228e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 30, 2020
Manufacturers
FDA
Sagent Pharmaceuticals
DUNS: 796852890
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 Code25021-780
Application NumberANDA091627
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levetiracetam
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 30, 2020
FDA Product Classification
INGREDIENTS (5)
waterInactive
Code: 059QF0KO0R
Classification: IACT
acetic acidInactive
Code: Q40Q9N063P
Classification: IACT
LevetiracetamActive
Quantity: 500 mg in 5 mL
Code: 44YRR34555
Classification: ACTIB
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
sodium acetateInactive
Code: 4550K0SC9B
Classification: IACT