MedPath

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

a70be430-21fa-49a4-84c1-134621ee2f4f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 16, 2019

Manufacturers
FDA

Atlantic Biologicals Corps

DUNS: 047437707

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 Code17856-0685
Application NumberANDA090992
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levetiracetam
Product Specifications
Route of AdministrationORAL
Effective DateOctober 14, 2019
FDA Product Classification

INGREDIENTS (8)

LEVETIRACETAMActive
Quantity: 100 mg in 1 mL
Code: 44YRR34555
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
MALTITOLInactive
Code: D65DG142WK
Classification: IACT
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT

Drug Labeling Information

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 3/27/2014

Manufactured by: Branchburg, NJ 08876
Amneal Pharmaceuticals


Distributed by: Glasgow, KY 42141
Amneal Pharmaceuticals


Rev. 03-2014

DOSAGE FORMS & STRENGTHS SECTION

LOINC: 43678-2Updated: 11/26/2012

3 DOSAGE FORMS AND STRENGTHS

Levetiracetam 100 mg/mL oral solution is a clear, colorless, grape-flavored liquid.

Key Highlight
  • 100 mg/mL solution (3)

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Levetiracetam - FDA Drug Approval Details