Levetiracetam

Product NDC
60432-831
11-digit product format
604320831
Labeler code
60432
Product ID
60432-831_19af8ef3-5c6c-4c80-8338-fd54e2fcb51b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
SOLUTION
Route
ORAL
Labeler
Morton Grove Pharmaceuticals, Inc.
Application
ANDA090028
Marketing category
ANDA
Marketing start
2010-03-18
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
2021-12-31
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 productproduct60432-831IInactivated by FDA2026-08-17
excluded packagepackage60432-83160432-831-16IInactivated by FDA2026-08-17

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 packagepackage60432-831-16d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage60432-831-16f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage60432-831-162ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage60432-831-16a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage60432-831-16cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage60432-831-16cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage60432-831-16302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage60432-831-16ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage60432-831-160efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage60432-831-16ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage60432-831-16367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage60432-831-16557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage60432-831-168af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage60432-831-16834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage60432-831-161332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A090028-001LEVETIRACETAMLEVETIRACETAM100MG/MLSOLUTION / ORAL2010-03-03

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A090028-001LEVETIRACETAM100MG/MLSOLUTION / ORAL2010-03-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090028-001LEVETIRACETAM100MG/MLSOLUTION / ORAL2010-03-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090028-001LEVETIRACETAM100MG/MLSOLUTION / ORAL2010-03-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A090028-001LEVETIRACETAM100MG/MLSOLUTION / ORAL2010-03-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090028-001LEVETIRACETAM100MG/MLSOLUTION / ORAL2010-03-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090028-001LEVETIRACETAM100MG/MLSOLUTION / ORAL2010-03-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090028-001LEVETIRACETAM100MG/MLSOLUTION / ORAL2010-03-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090028-001LEVETIRACETAM100MG/MLSOLUTION / ORAL2010-03-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090028-001LEVETIRACETAM100MG/MLSOLUTION / ORAL2010-03-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090028-001LEVETIRACETAM100MG/MLSOLUTION / ORAL2010-03-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090028-001LEVETIRACETAM100MG/MLSOLUTION / ORAL2010-03-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090028-001LEVETIRACETAM100MG/MLSOLUTION / ORAL2010-03-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090028-001LEVETIRACETAM100MG/MLSOLUTION / ORAL2010-03-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090028-001LEVETIRACETAM100MG/MLSOLUTION / ORAL2010-03-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090028-001LEVETIRACETAM100MG/MLSOLUTION / ORAL2010-03-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090028-001LEVETIRACETAM100MG/MLSOLUTION / ORAL2010-03-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090028-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2010-03-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090028-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2010-03-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090028-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2010-03-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090028-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2010-03-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090028-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2010-03-03782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090028-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2010-03-0387673890dc5c…
2021-03-12 10:30 UTC2021-03A090028-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2010-03-035aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090028-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2010-03-038869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090028-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2010-03-03c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090028-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2010-03-033f01610625f2…
2019-09-15 20:21 UTC2019-09A090028-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2010-03-03b00525d2431f…
2019-07-19 19:46 UTC2019-07A090028-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2010-03-03ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090028-001LEVETIRACETAM100MG/MLSOLUTION / ORAL2010-03-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090028-001LEVETIRACETAM100MG/MLSOLUTION / ORAL2010-03-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090028-001LEVETIRACETAM100MG/MLSOLUTION / ORAL2010-03-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090028-001LEVETIRACETAM100MG/MLSOLUTION / ORAL2010-03-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090028-001LEVETIRACETAM100MG/MLSOLUTION / ORAL2010-03-039b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090028-001LEVETIRACETAM100MG/MLSOLUTION / ORAL2010-03-03a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090028-001LEVETIRACETAM100MG/MLSOLUTION / ORAL2010-03-033f0d92c62455…
2023-05-13 08:27 UTC2023-05A090028-001LEVETIRACETAM100MG/MLSOLUTION / ORAL2010-03-03053a50430f4f…
2023-01-26 05:58 UTC2023-01A090028-001LEVETIRACETAM100MG/MLSOLUTION / ORAL2010-03-033bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090028-001LEVETIRACETAM100MG/MLSOLUTION / ORAL2010-03-033a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090028-001LEVETIRACETAM100MG/MLSOLUTION / ORAL2010-03-03f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090028-001LEVETIRACETAM100MG/MLSOLUTION / ORAL2010-03-03e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-04-08 23:34 UTC2022-04A090028-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090028-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090028-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090028-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090028-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090028-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A090028-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090028-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090028-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090028-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A090028-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090028-001AA1ea99ee380514…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60432-831-16Levetiracetam473 mL in 1 BOTTLE, PLASTICSOLUTION47314

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60432-831-16ML - Milliliter60432-831144b7fc4-fd8e-48a3-868a-20bdc7a3f67a12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60432-831LEVETIRACETAM SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]14Legacy NDC, 1 package rows20201224_3edcaae5-81bb-4a18-8bfd-834835187b13.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403884levETIRAcetam 100 MG in 1 mL Oral SolutionPSN3edcaae5-81bb-4a18-8bfd-834835187b1314
403884levetiracetam 100 MG/ML Oral SolutionSCD3edcaae5-81bb-4a18-8bfd-834835187b1314
403884levetiracetam 100 MG per 1 ML Oral SolutionSY3edcaae5-81bb-4a18-8bfd-834835187b1314
403884levetiracetam 1000 MG per 10 ML Oral SolutionSY3edcaae5-81bb-4a18-8bfd-834835187b1314
403884levetiracetam 1500 MG per 15 ML Oral SolutionSY3edcaae5-81bb-4a18-8bfd-834835187b1314
403884levetiracetam 500 MG per 5 ML Oral SolutionSY3edcaae5-81bb-4a18-8bfd-834835187b1314

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60432-831-1660432083116473 mL in 1 BOTTLE, PLASTIC (60432-831-16) 473 ml2010-03-180000-00-00NoNoCurrent