FDA.reportPublic FDA data

Levetiracetam

Product NDC
50090-3518
Requested package NDC
50090-3518-0
11-digit product format
500903518
Labeler code
50090
Product ID
50090-3518_0bd54726-f7eb-4845-9612-118a6d49677c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078106
Marketing category
ANDA
Marketing start
2012-09-11
Marketing end
0000-00-00
Substance
LEVETIRACETAM
Active strength
1000 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-351850090-3518-0IInactivated 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
50090-3518-02023-01-30C16284748780-1f386c64a-30df-0266-e053-dadaa90a7c1aThese 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
50090-3518-0Levetiracetam30 in 1 BOTTLETABLET, FILM COATED306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3518-0EA - Each50090-351848bbe159-94f7-42b9-b245-025e1e5b0ea012021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3518LEVETIRACETAM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]6Legacy NDC, 1 package rows20210417_e836e455-e1c0-482e-8d00-5be150399e08.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387003levETIRAcetam 1000 MG Oral TabletPSNe836e455-e1c0-482e-8d00-5be150399e086
387003levetiracetam 1000 MG Oral TabletSCDe836e455-e1c0-482e-8d00-5be150399e086

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3518-05009035180030 TABLET, FILM COATED in 1 BOTTLE (50090-3518-0) 2018-07-260000-00-00NoNoCurrent