FDA.reportPublic FDA data

Levetiracetam

Product NDC
63629-7516
11-digit product format
636297516
Labeler code
63629
Product ID
63629-7516_d310428a-bf9e-4838-b409-3282dde4890b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078106
Marketing category
ANDA
Marketing start
2012-09-11
Substance
LEVETIRACETAM
Active strength
1000 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

Additional Listing Data#

Finished product
Yes
Brand name base
Levetiracetam
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVETIRACETAM1000 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii44YRR34555
Rxcui387003

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
63629-7516-12024-05-16C16284748780-11030e365-1ddb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999
63629-7516-22024-05-16C16284748780-11030e365-1ddb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999
63629-7516-32024-05-16C16284748780-11030e365-1ddb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999
63629-7516-42024-05-16C16284748780-11030e365-1ddb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999
63629-7516-12024-01-30C16284748780-11030e365-1ddb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999
63629-7516-22024-01-30C16284748780-11030e365-1ddb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999
63629-7516-32024-01-30C16284748780-11030e365-1ddb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999
63629-7516-42024-01-30C16284748780-11030e365-1ddb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-7516-1Levetiracetam30 in 1 BOTTLETABLET, FILM COATED305
63629-7516-2Levetiracetam90 in 1 BOTTLETABLET, FILM COATED905
63629-7516-3Levetiracetam58 in 1 BOTTLETABLET, FILM COATED585
63629-7516-4Levetiracetam60 in 1 BOTTLETABLET, FILM COATED605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7516LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 4 package rows20240518_ed8e88d0-993e-4683-bdcf-31578130d3df.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387003levETIRAcetam 1000 MG Oral TabletPSNed8e88d0-993e-4683-bdcf-31578130d3df5
387003levetiracetam 1000 MG Oral TabletSCDed8e88d0-993e-4683-bdcf-31578130d3df5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-7516-16362975160130 TABLET, FILM COATED in 1 BOTTLE (63629-7516-1) 2024-04-030000-00-00NoNoCurrent
63629-7516-26362975160290 TABLET, FILM COATED in 1 BOTTLE (63629-7516-2) 2018-01-230000-00-00NoNoCurrent
63629-7516-36362975160358 TABLET, FILM COATED in 1 BOTTLE (63629-7516-3) 2024-04-030000-00-00NoNoCurrent
63629-7516-46362975160460 TABLET, FILM COATED in 1 BOTTLE (63629-7516-4) 2024-04-030000-00-00NoNoCurrent