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, for oral useInitial U.S. Approval: 1999
Approved
Approval ID
e5939df6-0b5f-4772-b2aa-2db92a1e8814
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 17, 2023
Manufacturers
FDA
ACI Healthcare USA, Inc.
DUNS: 080430318
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 Code71093-144
Application NumberANDA078582
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levetiracetam
Product Specifications
Route of AdministrationORAL
Effective DateAugust 13, 2020
FDA Product Classification
INGREDIENTS (10)
LEVETIRACETAMActive
Quantity: 100 mg in 1 mL
Code: 44YRR34555
Classification: ACTIB
CHERRYInactive
Code: BUC5I9595W
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT