Levetiracetam

Product NDC
67046-1615
11-digit product format
670461615
Labeler code
67046
Product ID
67046-1615_43df447e-dc5b-dc8f-e063-6294a90a8f9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Coupler LLC
Application
ANDA215069
Marketing category
ANDA
Marketing start
2025-11-18
Substance
LEVETIRACETAM
Active strength
750 mg/1
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 formatDescriptionMarketing startSampleExclude flagStatus
67046-1615-36704616150330 TABLET, FILM COATED in 1 BLISTER PACK (67046-1615-3) 2025-11-18NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
LevetiracetamCoupler LLC2025-11-18HUMAN PRESCRIPTION DRUG LABEL1