Levetiracetam

Product NDC
53041-660
11-digit product format
530410660
Labeler code
53041
Product ID
53041-660_afb5dc0d-459c-441a-bc79-d6a9b5428e10
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
SOLUTION
Route
ORAL
Labeler
Guardian Drug Company
Application
ANDA218080
Marketing category
ANDA
Marketing start
2025-12-02
Substance
LEVETIRACETAM
Active strength
100 mg/mL
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
44YRR34555LEVETIRACETAM102767-28-2LEVETIRACETAM

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53041-660-0653041066006473 mL in 1 BOTTLE (53041-660-06) 473 ml2025-12-02NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
LevetiracetamGuardian Drug Company2025-12-02Human Prescription Drug Label5