Levetiracetam

Product NDC
65162-538
11-digit product format
651620538
Labeler code
65162
Product ID
65162-538_3a499e5a-b4c5-46b8-b667-ee79134e488a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA090767
Marketing category
ANDA
Marketing start
2013-02-28
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
65162-538-1665162053816120 TABLET, FILM COATED in 1 BOTTLE (65162-538-16) 2013-02-28NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
LevetiracetamAmneal Pharmaceuticals LLC2017-11-28HUMAN PRESCRIPTION DRUG LABEL26