Levetiracetam

Product NDC
52343-071
11-digit product format
523430071
Labeler code
52343
Product ID
52343-071_b3cc95a0-a119-4799-b6e3-714a07e36efb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ACETRIS HEALTH, LLC
Application
ANDA078993
Marketing category
ANDA
Marketing start
2014-11-06
Marketing end
0000-00-00
Substance
LEVETIRACETAM
Active strength
750 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52343-071-05EA - Each52343-071f470db10-f5cd-4cb5-b3f8-99eec3c9124312015-02-02
52343-071-12EA - Each52343-071999e57ca-0245-45eb-bbc0-a556490440bd12015-02-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52343-071-0552343007105500 TABLET, FILM COATED in 1 BOTTLE (52343-071-05) 2014-11-060000-00-00NoNoCurrent
52343-071-1252343007112120 TABLET, FILM COATED in 1 BOTTLE (52343-071-12) 2014-11-060000-00-00NoNoCurrent