Levetiracetam
These highlights do not include all the information needed to use LEVETIRACETAM ORAL SOLUTION safely and effectively. See full prescribing information for LEVETIRACETAM ORAL SOLUTION.LEVETIRACETAM oral solutionInitial U.S. Approval: 1999
Approved
Approval ID
cb8aed34-2f3b-48b1-86ea-84b0d9e2b618
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 5, 2023
Manufacturers
FDA
Akorn
DUNS: 117696873
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 Code50383-241
Application NumberANDA090601
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levetiracetam
Product Specifications
Route of AdministrationORAL
Effective DateMay 26, 2022
FDA Product Classification
INGREDIENTS (10)
LEVETIRACETAMActive
Quantity: 100 mg in 1 mL
Code: 44YRR34555
Classification: ACTIB
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
AMMONIUM GLYCYRRHIZATEInactive
Code: 3VRD35U26C
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MALTITOLInactive
Code: D65DG142WK
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT