Levetiracetam

Product NDC
42291-388
11-digit product format
422910388
Labeler code
42291
Product ID
42291-388_639ecbfc-5070-680b-e053-2991aa0adb10
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
AvKARE, Inc.
Application
ANDA202167
Marketing category
ANDA
Marketing start
2016-07-28
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42291-388-602023-01-03C16284748780-1d6a99b39-9cca-a426-e053-dadaa90af4c29df8b8cf-8289-3be7-de7d-6ed855b500b3
42291-388-602022-01-28C16284748780-1d6a99b39-9cca-a426-e053-dadaa90af4c29df8b8cf-8289-3be7-de7d-6ed855b500b3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-388-60EA - Each42291-38862c2129b-9eeb-460b-964a-8369e8f12c7412016-09-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42291-388-604229103886060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-388-60) 2016-07-280000-00-00NoNoCurrent