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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078106-001LEVETIRACETAMLEVETIRACETAM250MGTABLET / ORALAB2009-02-10
A078106-002LEVETIRACETAMLEVETIRACETAM500MGTABLET / ORALAB2009-02-10
A078106-003LEVETIRACETAMLEVETIRACETAM750MGTABLET / ORALAB2009-02-10
A078106-004LEVETIRACETAMLEVETIRACETAM1GMTABLET / ORALAB2009-02-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A078106-001AB
A078106-002AB
A078106-003AB
A078106-004AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A078106-001LEVETIRACETAM250MGTABLET / ORALAB2009-02-10a50c72e98297…
2026-08-01 22:54:322026-06A078106-002LEVETIRACETAM500MGTABLET / ORALAB2009-02-10a50c72e98297…
2026-08-01 22:54:322026-06A078106-003LEVETIRACETAM750MGTABLET / ORALAB2009-02-10a50c72e98297…
2026-08-01 22:54:322026-06A078106-004LEVETIRACETAM1GMTABLET / ORALAB2009-02-10a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A078106-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A078106-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A078106-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A078106-004AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevetiracetamLEVETIRACETAMBryant Ranch Prepacked8e88d0-993e-4683-bdcf-31578130d3df2024-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078106
application number: ANDA078106
ndc (product): 63629-7516
LevetiracetamLEVETIRACETAMSolco Healthcare US, LLC57f09129-7151-4a75-9d73-9dd32f74ba432024-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078106
application number: ANDA078106
LevetiracetamLEVETIRACETAMSolco Healthcare US, LLCdd713e60-478c-43cd-b680-ff594a0b38642024-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078106
application number: ANDA078106
LevetiracetamLEVETIRACETAMPrinston Pharmaceutical Inc.d818ef84-9b3e-434b-92d9-910cfa8af7da2020-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078106
application number: ANDA078106

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
44YRR34555Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
387003Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ed8e88d0-993e-4683-bdcf-31578130d3dfAvailable on FDA.report

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