Levetiracetam
These highlights do not include all the information needed to use LEVETIRACETAM oral solution USP safely and effectively. See full prescribing information for Levetiracetam Oral Solution USP. Levetiracetam Oral Solution USP Initial U.S. Approval: 1999
Approved
Approval ID
3a472ddb-ecde-4d51-adbc-d95a96cf85d3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 14, 2021
Manufacturers
FDA
PINNACLE PHARMA LLC
DUNS: 081126970
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 Code81646-116
Application NumberANDA201157
Product Classification
M
Marketing Category
C73584
G
Generic Name
LEVETIRACETAM
Product Specifications
Route of AdministrationORAL
Effective DateMay 13, 2021
FDA Product Classification
INGREDIENTS (9)
LEVETIRACETAMActive
Quantity: 500 mg in 5 mL
Code: 44YRR34555
Classification: ACTIB
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
MALTITOLInactive
Code: D65DG142WK
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT