FDA.reportPublic FDA data

Levetiracetam

Product NDC
50090-2456
11-digit product format
500902456
Labeler code
50090
Product ID
50090-2456_8764bb80-643d-4ab3-adce-f5bf59e9f640
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078154
Marketing category
ANDA
Marketing start
2009-01-15
Marketing end
0000-00-00
Substance
LEVETIRACETAM
Active strength
500 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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
76e81f18-c6b9-f226-530a-a6296d5cd5f4Product name620251106
087c9486-f4a9-a565-c6fb-d6fa49f4572aProduct name620230317
525a8d4d-1988-fc3f-e292-27fd384de4f0Product name820230104
32b651f8-caa7-6882-11c7-54c4ad21796bProduct name820201216
ce453ca5-90cf-41ed-9de4-de519f70a0f2Product name220160303
66666eb8-1fa6-4a60-bae9-e564e73b4cd5Product name120150728
eecbc0ef-ab5c-4ff9-8aaa-6ea73ee46477Product name120150410

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2456-02024-01-30C16284748780-11030e364-f95a-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use LEVETIRACETAM TABLETS USP safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS USP. LEVETIRACETAM tablets USP, for oral use Initial U.S. Approval: 1999
50090-2456-22024-01-30C16284748780-11030e364-f95a-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use LEVETIRACETAM TABLETS USP safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS USP. LEVETIRACETAM tablets USP, for oral use Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2456-0Levetiracetam120 in 1 BOTTLETABLET, FILM COATED12014
50090-2456-2Levetiracetam90 in 1 BOTTLETABLET, FILM COATED9014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2456LEVETIRACETAM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]14Legacy NDC, 2 package rows20220804_b1b76aed-d2bf-4da7-8166-031d4227eb57.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311289levETIRAcetam 500 MG Oral TabletPSNb1b76aed-d2bf-4da7-8166-031d4227eb5714
311289levetiracetam 500 MG Oral TabletSCDb1b76aed-d2bf-4da7-8166-031d4227eb5714

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-2456-050090245600120 TABLET, FILM COATED in 1 BOTTLE (50090-2456-0) 2016-08-120000-00-00NoNoCurrent
50090-2456-25009024560290 TABLET, FILM COATED in 1 BOTTLE (50090-2456-2) 2021-06-040000-00-00NoNoCurrent