Levetiracetam

Product NDC
24451-548
11-digit product format
244510548
Labeler code
24451
Product ID
24451-548_1479dec5-5734-433b-898b-83d655c8a345
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
SOLUTION
Route
ORAL
Labeler
LLC Federal Solutions
Application
ANDA090263
Marketing category
ANDA
Marketing start
2013-09-24
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
E
Listing certified through
2017-12-31
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 productproduct24451-548DDiscontinued by firm2026-08-10
excluded packagepackage24451-54824451-548-05DDiscontinued by firm2026-08-10

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 · 26 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 productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage24451-548-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage24451-548-05DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage24451-548-05DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage24451-548-05DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage24451-548-05DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage24451-548-05DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage24451-548-05DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage24451-548-05DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage24451-548-05DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage24451-548-05DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage24451-548-05DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage24451-548-05DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductIInactivated by FDA110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage24451-548-05IInactivated by FDA110d247fa046…a55b01930146…

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

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
A090263-001LEVETIRACETAMLEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090263-001AA

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-03782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-0387673890dc5c…
2021-03-12 10:30 UTC2021-03A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-035aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-038869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-03c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-033f01610625f2…
2019-09-15 20:21 UTC2019-09A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-03b00525d2431f…
2019-07-19 19:46 UTC2019-07A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-03ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-039b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-03a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-033f0d92c62455…
2023-05-13 08:27 UTC2023-05A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-03053a50430f4f…
2023-01-26 05:58 UTC2023-01A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-033bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-033a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-03f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-03e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-03cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090263-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090263-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090263-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090263-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090263-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090263-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090263-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090263-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090263-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090263-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090263-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090263-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090263-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090263-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090263-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090263-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090263-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090263-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090263-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090263-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090263-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A090263-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090263-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090263-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090263-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A090263-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090263-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090263-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090263-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090263-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090263-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090263-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090263-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090263-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090263-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090263-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090263-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090263-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090263-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090263-001AA1cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
24451-548-052020-01-07C16284748780-19855d018-e49b-cd31-e053-dbdaa90ab51ae59f2fec-52d2-428f-a43a-c1d6c0f83f33
24451-548-052019-11-27C16284748780-19855d018-e49b-cd31-e053-dbdaa90ab51ae59f2fec-52d2-428f-a43a-c1d6c0f83f33

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LevetiracetamACTIVE INGREDIENT44YRR34555LEVETIRACETAM SOLUTION [LLC FEDERAL SOLUTIONS]1
LevetiracetamACTIVE MOIETY44YRR34555LEVETIRACETAM SOLUTION [LLC FEDERAL SOLUTIONS]1
acesulfame potassiumINACTIVE INGREDIENT23OV73Q5G9LEVETIRACETAM SOLUTION [LLC FEDERAL SOLUTIONS]1
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLLEVETIRACETAM SOLUTION [LLC FEDERAL SOLUTIONS]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXLEVETIRACETAM SOLUTION [LLC FEDERAL SOLUTIONS]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TLEVETIRACETAM SOLUTION [LLC FEDERAL SOLUTIONS]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHLEVETIRACETAM SOLUTION [LLC FEDERAL SOLUTIONS]1
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRLEVETIRACETAM SOLUTION [LLC FEDERAL SOLUTIONS]1
sorbitolINACTIVE INGREDIENT506T60A25RLEVETIRACETAM SOLUTION [LLC FEDERAL SOLUTIONS]1
waterINACTIVE INGREDIENT059QF0KO0RLEVETIRACETAM SOLUTION [LLC FEDERAL SOLUTIONS]1

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LEVETIRACETAM solutionLEVETIRACETAMChartwell RX, LLC61eb57a9-5df2-4426-9f0c-a75e2f356b112026-03-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090263
application number: ANDA090263
LEVETIRACETAM solutionLEVETIRACETAMChartwell Governmental & Specialty RX, LLC.e1ebd960-79a4-4632-b727-4e98118241132025-11-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090263
application number: ANDA090263