Levetiracetam

Product NDC
58118-1112
11-digit product format
581181112
Labeler code
58118
Product ID
58118-1112_ebc856c3-6b0e-ee8a-e053-2995a90adbc6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Clinical Solutions Wholesale, LLC
Application
ANDA078154
Marketing category
ANDA
Marketing start
2018-02-01
Marketing end
0000-00-00
Substance
LEVETIRACETAM
Active strength
250 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58118-1112-82024-01-30C16284748780-11030e365-0d96-111a-e063-dadaa90a10e25faf45cc-1f43-47e5-a375-441b63a3fca4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58118-1112LEVETIRACETAM TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC]5Legacy NDC20221027_5faf45cc-1f43-47e5-a375-441b63a3fca4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58118-1112-85811811120830 TABLET, FILM COATED in 1 BLISTER PACK (58118-1112-8) 2018-02-010000-00-00NoNoCurrent