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 solution Initial U.S. Approval: 1999
Approved
Approval ID
5c4877cc-52bc-4f98-a995-0aa9439da742
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 10, 2023
Manufacturers
FDA
Amneal Pharmaceuticals LLC
DUNS: 123797875
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Levetiracetam
PRODUCT DETAILS
NDC Product Code65162-685
Application NumberANDA090992
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 11, 2024
Generic NameLevetiracetam
INGREDIENTS (8)
LEVETIRACETAMActive
Quantity: 100 mg in 1 mL
Code: 44YRR34555
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
MALTITOLInactive
Code: D65DG142WK
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT