Levetiracetam

Basic Information

Product Name

Levetiracetam

FDA Product Code

17856-0685

Regulatory Information

NDC Product Code

17856-0685

Application Number

ANDA090992

Marketing Category

C73584

Effective Date

October 14, 2019

Territorial Authority

USA

FDA Title

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

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

LEVETIRACETAM

Quantity: 100 mg in 1 mL

Code: 44YRR34555

Class Code: ACTIB

ANHYDROUS CITRIC ACID

Code: XF417D3PSL

Class Code: IACT

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

MALTITOL

Code: D65DG142WK

Class Code: IACT

ACESULFAME POTASSIUM

Code: 23OV73Q5G9

Class Code: IACT

METHYLPARABEN

Code: A2I8C7HI9T

Class Code: IACT

PROPYLPARABEN

Code: Z8IX2SC1OH

Class Code: IACT

SODIUM CITRATE

Code: 1Q73Q2JULR

Class Code: IACT

Active Moieties

Code: 44YRR34555

Levetiracetam

Basic Information

Regulatory Information

Company Information

Active Ingredients

ANHYDROUS CITRIC ACID

GLYCERIN

MALTITOL

ACESULFAME POTASSIUM

METHYLPARABEN

PROPYLPARABEN

SODIUM CITRATE

Active Moieties

LEVETIRACETAM