Levetiracetam

Product NDC
81646-116
11-digit product format
816460116
Labeler code
81646
Product ID
81646-116_a279dd0a-b4f9-4b28-8d1c-1c4d58fefa7c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVETIRACETAM
Dosage form
SOLUTION
Route
ORAL
Labeler
PINNACLE PHARMA LLC
Application
ANDA201157
Marketing category
ANDA
Marketing start
2015-06-04
Marketing end
0000-00-00
Substance
LEVETIRACETAM
Active strength
500 mg/5mL
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#

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 productproduct81646-116IInactivated by FDA2026-08-03
excluded packagepackage81646-11681646-116-05IInactivated by FDA2026-08-03

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage81646-116-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage81646-116-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage81646-116-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage81646-116-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage81646-116-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage81646-116-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage81646-116-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage81646-116-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage81646-116-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage81646-116-05ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage81646-116-05367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage81646-116-05557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage81646-116-058af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage81646-116-05834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage81646-116-051332a3947898…d4bfe170f9cd…

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
A201157-001LEVETIRACETAMLEVETIRACETAM100MG/MLSOLUTION / ORALAA2015-06-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A201157-001AA

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 UTC2026-02A201157-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2015-06-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201157-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2015-06-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A201157-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2015-06-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201157-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2015-06-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201157-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2015-06-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201157-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2015-06-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201157-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2015-06-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201157-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2015-06-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201157-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2015-06-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201157-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2015-06-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201157-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2015-06-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201157-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2015-06-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201157-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2015-06-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201157-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2015-06-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201157-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2015-06-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201157-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2015-06-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201157-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2015-06-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201157-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2015-06-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201157-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2015-06-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201157-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2015-06-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201157-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2015-06-0487673890dc5c…
2021-03-12 10:30 UTC2021-03A201157-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2015-06-045aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A201157-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2015-06-048869cabd3fbd…
2020-11-12 02:37 UTC2020-11A201157-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2015-06-04c0c555d07b60…
2019-12-14 00:12 UTC2019-12A201157-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2015-06-043f01610625f2…
2019-09-15 20:21 UTC2019-09A201157-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2015-06-04b00525d2431f…
2019-07-19 19:46 UTC2019-07A201157-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2015-06-04ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201157-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2015-06-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A201157-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2015-06-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12A201157-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2015-06-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A201157-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2015-06-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A201157-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2015-06-049b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A201157-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2015-06-04a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A201157-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2015-06-043f0d92c62455…
2023-05-13 08:27 UTC2023-05A201157-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2015-06-04053a50430f4f…
2023-01-26 05:58 UTC2023-01A201157-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2015-06-043bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A201157-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2015-06-043a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A201157-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2015-06-04f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A201157-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2015-06-04e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A201157-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2015-06-04cb3db0bc1861…

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 UTC2026-02A201157-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201157-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201157-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201157-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201157-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201157-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201157-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201157-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201157-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201157-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201157-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201157-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201157-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201157-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201157-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201157-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201157-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201157-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201157-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201157-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201157-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A201157-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A201157-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A201157-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A201157-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A201157-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A201157-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201157-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A201157-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A201157-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A201157-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A201157-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A201157-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A201157-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A201157-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A201157-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A201157-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A201157-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A201157-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A201157-001AA1cb3db0bc1861…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81646-116-05Levetiracetam5 mL in 1 CUP, UNIT-DOSESOLUTION52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81646-116LEVETIRACETAM SOLUTION [PINNACLE PHARMA LLC]2Legacy NDC, 1 package rows20210515_3a472ddb-ecde-4d51-adbc-d95a96cf85d3.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevetiracetamLEVETIRACETAMCardinal Health 107, LLCa91defd2-486b-4995-ba4c-640525ab575d2026-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201157
application number: ANDA201157
LevetiracetamLEVETIRACETAMCardinal Health 107, LLCf924d55d-d7ec-4448-b54e-3a7eaf5a1cab2026-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201157
application number: ANDA201157
LevetiracetamLEVETIRACETAMMajor Pharmaceuticals423d2185-0931-4414-8864-7594000809ee2024-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201157
application number: ANDA201157
LevetiracetamLEVETIRACETAMPAI Holdings, LLC dba PAI Pharma9dca1330-52ca-47a4-a134-ec55c9d5786d2024-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201157
application number: ANDA201157

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403884levETIRAcetam 100 MG in 1 mL Oral SolutionPSN3a472ddb-ecde-4d51-adbc-d95a96cf85d32
403884levetiracetam 100 MG/ML Oral SolutionSCD3a472ddb-ecde-4d51-adbc-d95a96cf85d32
403884levetiracetam 100 MG per 1 ML Oral SolutionSY3a472ddb-ecde-4d51-adbc-d95a96cf85d32
403884levetiracetam 1000 MG per 10 ML Oral SolutionSY3a472ddb-ecde-4d51-adbc-d95a96cf85d32
403884levetiracetam 1500 MG per 15 ML Oral SolutionSY3a472ddb-ecde-4d51-adbc-d95a96cf85d32
403884levetiracetam 500 MG per 5 ML Oral SolutionSY3a472ddb-ecde-4d51-adbc-d95a96cf85d32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81646-116-05816460116055 mL in 1 CUP, UNIT-DOSE (81646-116-05) 5 ml2015-06-040000-00-00NoNoCurrent