Levetiracetam

Product NDC
50383-241
Requested package NDC
50383-241-08
11-digit product format
503830241
Labeler code
50383
Product ID
50383-241_a9bd3532-5fcb-4811-95f6-d811eae8cd29
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
SOLUTION
Route
ORAL
Labeler
Akorn
Application
ANDA090601
Marketing category
ANDA
Marketing start
2012-02-28
Marketing end
0000-00-00
Substance
LEVETIRACETAM
Active strength
100 mg/mL
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2024-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50383-24150383-241-08DDiscontinued by firm2026-10-05

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090601-001LEVETIRACETAMLEVETIRACETAM100MG/MLSOLUTION / ORAL2012-02-28

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 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090601-001LEVETIRACETAM100MG/MLSOLUTION / ORAL2012-02-2884e616aacf4f…
2026-08-18 06:07:402026-07A090601-001LEVETIRACETAM100MG/MLSOLUTION / ORAL2012-02-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090601-001LEVETIRACETAM100MG/MLSOLUTION / ORAL2012-02-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090601-001LEVETIRACETAM100MG/MLSOLUTION / ORAL2012-02-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A090601-001LEVETIRACETAM100MG/MLSOLUTION / ORAL2012-02-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090601-001LEVETIRACETAM100MG/MLSOLUTION / ORAL2012-02-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090601-001LEVETIRACETAM100MG/MLSOLUTION / ORAL2012-02-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090601-001LEVETIRACETAM100MG/MLSOLUTION / ORAL2012-02-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090601-001LEVETIRACETAM100MG/MLSOLUTION / ORAL2012-02-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090601-001LEVETIRACETAM100MG/MLSOLUTION / ORAL2012-02-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090601-001LEVETIRACETAM100MG/MLSOLUTION / ORAL2012-02-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090601-001LEVETIRACETAM100MG/MLSOLUTION / ORAL2012-02-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090601-001LEVETIRACETAM100MG/MLSOLUTION / ORAL2012-02-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090601-001LEVETIRACETAM100MG/MLSOLUTION / ORAL2012-02-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090601-001LEVETIRACETAM100MG/MLSOLUTION / ORAL2012-02-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090601-001LEVETIRACETAM100MG/MLSOLUTION / ORAL2012-02-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090601-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2012-02-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090601-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2012-02-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090601-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2012-02-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090601-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2012-02-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090601-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2012-02-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090601-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2012-02-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090601-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2012-02-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A090601-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2012-02-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090601-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2012-02-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090601-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2012-02-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090601-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2012-02-283f01610625f2…
2019-09-15 20:21 UTC2019-09A090601-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2012-02-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A090601-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2012-02-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090601-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2012-02-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090601-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2012-02-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090601-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2012-02-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090601-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2012-02-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090601-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2012-02-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090601-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2012-02-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090601-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2012-02-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A090601-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2012-02-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A090601-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2012-02-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090601-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2012-02-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090601-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2012-02-28f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090601-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090601-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090601-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090601-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090601-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090601-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090601-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A090601-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090601-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090601-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090601-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A090601-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090601-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090601-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090601-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090601-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090601-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090601-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090601-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090601-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090601-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090601-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090601-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090601-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090601-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090601-001AA1cb3db0bc1861…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
76e81f18-c6b9-f226-530a-a6296d5cd5f4Product name620251106
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
087c9486-f4a9-a565-c6fb-d6fa49f4572aProduct name620230317
525a8d4d-1988-fc3f-e292-27fd384de4f0Product name820230104
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
32b651f8-caa7-6882-11c7-54c4ad21796bProduct name820201216
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
ce453ca5-90cf-41ed-9de4-de519f70a0f2Product name220160303
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
66666eb8-1fa6-4a60-bae9-e564e73b4cd5Product name120150728
eecbc0ef-ab5c-4ff9-8aaa-6ea73ee46477Product name120150410

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50383-241-062024-07-30These highlights do not include all the information needed to use LEVETIRACETAM ORAL SOLUTION safely and effectively. See full prescribing information for LEVETIRACETAM ORAL SOLUTION. LEVETIRACETAM oral solution Initial U.S. Approval: 1999
50383-241-082024-07-30These highlights do not include all the information needed to use LEVETIRACETAM ORAL SOLUTION safely and effectively. See full prescribing information for LEVETIRACETAM ORAL SOLUTION. LEVETIRACETAM oral solution Initial U.S. Approval: 1999
50383-241-112024-07-30These highlights do not include all the information needed to use LEVETIRACETAM ORAL SOLUTION safely and effectively. See full prescribing information for LEVETIRACETAM ORAL SOLUTION. LEVETIRACETAM oral solution Initial U.S. Approval: 1999
50383-241-162024-07-30These highlights do not include all the information needed to use LEVETIRACETAM ORAL SOLUTION safely and effectively. See full prescribing information for LEVETIRACETAM ORAL SOLUTION. LEVETIRACETAM oral solution Initial U.S. Approval: 1999
50383-241-062024-01-30These highlights do not include all the information needed to use LEVETIRACETAM ORAL SOLUTION safely and effectively. See full prescribing information for LEVETIRACETAM ORAL SOLUTION. LEVETIRACETAM oral solution Initial U.S. Approval: 1999
50383-241-082024-01-30These highlights do not include all the information needed to use LEVETIRACETAM ORAL SOLUTION safely and effectively. See full prescribing information for LEVETIRACETAM ORAL SOLUTION. LEVETIRACETAM oral solution Initial U.S. Approval: 1999
50383-241-112024-01-30These highlights do not include all the information needed to use LEVETIRACETAM ORAL SOLUTION safely and effectively. See full prescribing information for LEVETIRACETAM ORAL SOLUTION. LEVETIRACETAM oral solution Initial U.S. Approval: 1999
50383-241-162024-01-30These highlights do not include all the information needed to use LEVETIRACETAM ORAL SOLUTION safely and effectively. See full prescribing information for LEVETIRACETAM ORAL SOLUTION. LEVETIRACETAM oral solution Initial U.S. Approval: 1999

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-241-05ML - Milliliter50383-241163f9342-466f-4f59-b291-b8c8437f054212017-04-05
50383-241-06ML - Milliliter50383-24151543539-03f2-476a-b623-054e2a8cb3ec12017-04-05
50383-241-16ML - Milliliter50383-241c7b25572-cece-4a22-9883-7a3c3898a11612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
levetiracetamACTIVE INGREDIENT44YRR34555LEVETIRACETAM SOLUTION [HI-TECH PHARMACAL CO., INC.]11
levetiracetamACTIVE MOIETY44YRR34555LEVETIRACETAM SOLUTION [HI-TECH PHARMACAL CO., INC.]11
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9LEVETIRACETAM SOLUTION [HI-TECH PHARMACAL CO., INC.]11
AMMONIUM GLYCYRRHIZATEINACTIVE INGREDIENT3VRD35U26CLEVETIRACETAM SOLUTION [HI-TECH PHARMACAL CO., INC.]11
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLLEVETIRACETAM SOLUTION [HI-TECH PHARMACAL CO., INC.]11
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLEVETIRACETAM SOLUTION [HI-TECH PHARMACAL CO., INC.]11
MALTITOLINACTIVE INGREDIENTD65DG142WKLEVETIRACETAM SOLUTION [HI-TECH PHARMACAL CO., INC.]11
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLEVETIRACETAM SOLUTION [HI-TECH PHARMACAL CO., INC.]11
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLEVETIRACETAM SOLUTION [HI-TECH PHARMACAL CO., INC.]11
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KLEVETIRACETAM SOLUTION [HI-TECH PHARMACAL CO., INC.]11
WATERINACTIVE INGREDIENT059QF0KO0RLEVETIRACETAM SOLUTION [HI-TECH PHARMACAL CO., INC.]11
levetiracetamACTIVE INGREDIENT44YRR34555LEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
levetiracetamACTIVE MOIETY44YRR34555LEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9LEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
AMMONIUM GLYCYRRHIZATEINACTIVE INGREDIENT3VRD35U26CLEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLLEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
MALTITOLINACTIVE INGREDIENTD65DG142WKLEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KLEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
WATERINACTIVE INGREDIENT059QF0KO0RLEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-241LEVETIRACETAM SOLUTION [AKORN]24Legacy NDC20230107_cb8aed34-2f3b-48b1-86ea-84b0d9e2b618.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403884levETIRAcetam 100 MG in 1 mL Oral SolutionPSN0d0fa6a4-0fca-4114-b5a5-77f9efac7fe211
403884levetiracetam 100 MG/ML Oral SolutionSCD0d0fa6a4-0fca-4114-b5a5-77f9efac7fe211
403884levetiracetam 100 MG per 1 ML Oral SolutionSY0d0fa6a4-0fca-4114-b5a5-77f9efac7fe211
403884levetiracetam 1000 MG per 10 ML Oral SolutionSY0d0fa6a4-0fca-4114-b5a5-77f9efac7fe211
403884levetiracetam 1500 MG per 15 ML Oral SolutionSY0d0fa6a4-0fca-4114-b5a5-77f9efac7fe211
403884levetiracetam 500 MG per 5 ML Oral SolutionSY0d0fa6a4-0fca-4114-b5a5-77f9efac7fe211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50383-241-08503830241084 TRAY in 1 CASE (50383-241-08) > 10 CUP, UNIT-DOSE in 1 TRAY > 7.5 mL in 1 CUP, UNIT-DOSE (50383-241-07) 4 tray2015-12-010000-00-00NoNoCurrent