LEVERTIRACETAM

Product NDC
61919-830
11-digit product format
619190830
Labeler code
61919
Product ID
61919-830_8a719215-d0d5-42fb-e053-2a95a90a60da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVERTIRACETAM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA078993
Marketing category
ANDA
Marketing start
2019-06-03
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
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61919-830IInactivated by FDA2026-08-07
excluded packagepackage61919-83061919-830-60IInactivated by FDA2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-830-60IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-830-60IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-830-60IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-830-60IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-830-60IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-830-60IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-830-60UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-830-60UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-830-60UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
A078993-001LEVETIRACETAMLEVETIRACETAM250MGTABLET / ORALAB2009-01-15
A078993-002LEVETIRACETAMLEVETIRACETAM500MGTABLET / ORALAB2009-01-15
A078993-003LEVETIRACETAMLEVETIRACETAM750MGTABLET / ORALAB2009-01-15
A078993-004LEVETIRACETAMLEVETIRACETAM1GMTABLET / ORALAB2009-01-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078993-001AB
A078993-002AB
A078993-003AB
A078993-004AB

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.

Product history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078993-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078993-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078993-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078993-004LEVETIRACETAM1GMTABLET / ORALAB2009-01-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078993-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078993-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078993-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078993-004LEVETIRACETAM1GMTABLET / ORALAB2009-01-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078993-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078993-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078993-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078993-004LEVETIRACETAM1GMTABLET / ORALAB2009-01-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078993-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078993-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078993-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078993-004LEVETIRACETAM1GMTABLET / ORALAB2009-01-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078993-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078993-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078993-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078993-004LEVETIRACETAM1GMTABLET / ORALAB2009-01-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078993-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078993-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078993-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078993-004LEVETIRACETAM1GMTABLET / ORALAB2009-01-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078993-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078993-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078993-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078993-004LEVETIRACETAM1GMTABLET / ORALAB2009-01-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078993-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078993-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078993-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078993-004LEVETIRACETAM1GMTABLET / ORALAB2009-01-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078993-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078993-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078993-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078993-004LEVETIRACETAM1GMTABLET / ORALAB2009-01-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078993-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A078993-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A078993-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A078993-004LEVETIRACETAM1GMTABLET / ORALAB2009-01-15d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078993-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078993-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078993-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078993-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078993-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078993-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078993-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078993-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078993-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078993-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078993-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078993-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078993-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078993-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078993-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078993-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078993-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078993-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078993-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078993-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078993-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078993-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078993-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078993-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078993-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078993-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078993-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078993-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078993-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078993-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078993-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078993-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078993-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078993-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078993-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078993-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078993-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078993-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078993-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078993-004AB1d06236e962d9…

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
61919-830-602025-01-30C16284748780-12cef2736-9c71-d83d-e063-dadaa90ab31fLEVERTIRACETAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-830-60LEVERTIRACETAM60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-830-60EA - Each61919-8304c6e1d87-c37e-4568-a1b2-ccb49a992c6112019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-830LEVERTIRACETAM TABLET, FILM COATED [DIRECT_RX]1Legacy NDC, 1 package rows20190604_8a719215-d0d4-42fb-e053-2a95a90a60da.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevetiracetamLEVETIRACETAMUnit Dose Solutions, Inc.551626eb-3282-e439-e063-6294a90a83142026-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078993
application number: ANDA078993
LevetiracetamLEVETIRACETAMCoupler LLC53843871-23e3-974e-e063-6394a90a80422026-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078993
application number: ANDA078993
LevetiracetamLEVETIRACETAMCoupler LLC51b66893-f7d6-8f9d-e063-6294a90a8e9b2026-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078993
application number: ANDA078993
LevetiracetamLEVETIRACETAMCoupler LLC5037a86a-21f2-d793-e063-6394a90a2cb52026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078993
application number: ANDA078993
LevetiracetamLEVETIRACETAMA-S Medication Solutions6e31e766-6504-4f20-8831-1953363cace02025-11-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078993
application number: ANDA078993
LevetiracetamLEVETIRACETAMA-S Medication Solutions01aef7f7-6092-4e39-8451-dc02d8db92542025-11-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078993
application number: ANDA078993
LevetiracetamLEVETIRACETAMA-S Medication Solutions58ed7049-44c6-4f97-9174-c0e1504586a62025-11-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078993
application number: ANDA078993
LevetiracetamLEVETIRACETAMA-S Medication Solutions5eb7bea5-c95f-4a38-a5bb-c20d1549c7972025-11-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078993
application number: ANDA078993
LevetiracetamLEVETIRACETAMA-S Medication Solutionsbc12f0b0-e05c-48e4-ad08-0ff14a818a642025-11-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078993
application number: ANDA078993
LevetiracetamLEVETIRACETAMMajor Pharmaceuticalsc4b27429-50a3-467c-a5ff-7e49a01a10882025-09-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078993
application number: ANDA078993
LevetiracetamLEVETIRACETAMCardinal Health 107, LLC0348fec4-d919-4307-ac90-35360819bc002025-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078993
application number: ANDA078993
LevetiracetamLEVETIRACETAMBluePoint Laboratories8b74b8bc-d95c-4471-8f74-c3117243bf892024-12-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078993
application number: ANDA078993
LevetiracetamLEVETIRACETAMAmerican Health Packagingfc8bf57e-8aa2-4d3c-856d-b19de65e3ba02024-11-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078993
application number: ANDA078993
LevetiracetamLEVETIRACETAMAmerican Health Packaging031a32e1-675a-4efe-a66b-40beb4fe51012024-06-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078993
application number: ANDA078993
LevetiracetamLEVETIRACETAMAurobindo Pharma Limited2471ee03-d747-4113-86d0-1aa93c8f3eba2024-04-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078993
application number: ANDA078993

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387003levETIRAcetam 1000 MG Oral TabletPSN8a719215-d0d4-42fb-e053-2a95a90a60da1
387003levetiracetam 1000 MG Oral TabletSCD8a719215-d0d4-42fb-e053-2a95a90a60da1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-830-606191908306060 TABLET, FILM COATED in 1 BOTTLE (61919-830-60) 2019-06-030000-00-00NoNoCurrent