FDA.reportPublic FDA data

LEVETIRACETAM

Product NDC
61919-552
11-digit product format
619190552
Labeler code
61919
Product ID
61919-552_e9adf8f1-95f0-5d73-e053-2a95a90a0fc2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVETIRACETAM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA078106
Marketing category
ANDA
Marketing start
2019-08-28
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61919-552DDiscontinued by firm2026-07-31
excluded productproduct61919-552IInactivated by FDA2026-07-31
excluded packagepackage61919-55261919-552-60DDiscontinued by firm2026-07-31
excluded packagepackage61919-55261919-552-30IInactivated by FDA2026-07-31
excluded packagepackage61919-55261919-552-72IInactivated by FDA2026-07-31

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
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

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
61919-552-302025-01-30C16284748780-12cef2736-875b-d83d-e063-dadaa90ab31fLEVETIRACETAM
61919-552-722025-01-30C16284748780-12cef2736-875b-d83d-e063-dadaa90ab31fLEVETIRACETAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-552-30LEVETIRACETAM30 in 1 BOTTLETABLET, FILM COATED303
61919-552-72LEVETIRACETAM120 in 1 BOTTLETABLET, FILM COATED1203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-552-60EA - Each61919-552ed59cc42-a774-483a-a206-19733ec807ef12019-08-06
61919-552-72EA - Each61919-5524746ada4-1fbe-4c19-aef2-db0afea31f5812019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-552LEVETIRACETAM TABLET, FILM COATED [DIRECT_RX]3Legacy NDC, 2 package rows20230509_912f771a-2cd0-2625-e053-2995a90a2244.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311288levETIRAcetam 250 MG Oral TabletPSN912f771a-2cd0-2625-e053-2995a90a22443
311288levetiracetam 250 MG Oral TabletSCD912f771a-2cd0-2625-e053-2995a90a22443

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-552-306191905523030 TABLET, FILM COATED in 1 BOTTLE (61919-552-30) 2019-08-280000-00-00NoNoCurrent
61919-552-606191905526060 TABLET, FILM COATED in 1 BOTTLE (61919-552-60) 2018-07-300000-00-00NoNoCurrent
61919-552-7261919055272120 TABLET, FILM COATED in 1 BOTTLE (61919-552-72) 2019-08-280000-00-00NoNoCurrent