Levetiracetam

Product NDC
63187-360
11-digit product format
631870360
Labeler code
63187
Product ID
63187-360_e47bfa3c-961e-45d8-a06a-d2d2a91fe115
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078154
Marketing category
ANDA
Marketing start
2009-01-01
Substance
LEVETIRACETAM
Active strength
500 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
63187-360-306318703603030 TABLET, FILM COATED in 1 BOTTLE (63187-360-30) 2016-08-01NoNoHistorical
63187-360-606318703606060 TABLET, FILM COATED in 1 BOTTLE (63187-360-60) 2016-08-01NoNoHistorical
63187-360-906318703609090 TABLET, FILM COATED in 1 BOTTLE (63187-360-90) 2016-08-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
LevetiracetamProficient Rx LP2024-03-01HUMAN PRESCRIPTION DRUG LABEL4