LEVETIRACETAM

Product NDC
13811-621
11-digit product format
138110621
Labeler code
13811
Product ID
13811-621_aee7e0ad-d868-4652-be59-ba508d0beacb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Trigen Laboratories, Inc.
Application
ANDA090906
Marketing category
ANDA
Marketing start
2012-03-31
Marketing end
0000-00-00
Substance
LEVETIRACETAM
Active strength
500 mg/1
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct13811-621DDiscontinued by firm2026-09-14
excluded packagepackage13811-62113811-621-12DDiscontinued by firm2026-09-14
excluded packagepackage13811-62113811-621-50DDiscontinued by firm2026-09-14

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 · 36 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 packagepackage13811-621-50d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage13811-621-12d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13811-621-50f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13811-621-12f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13811-621-502ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13811-621-122ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13811-621-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13811-621-12a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13811-621-50cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13811-621-12cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13811-621-50cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13811-621-12cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13811-621-50302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13811-621-12302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage13811-621-50ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage13811-621-12ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage13811-621-500efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage13811-621-120efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage13811-621-50ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage13811-621-12ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage13811-621-50367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage13811-621-12367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage13811-621-50557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage13811-621-12557ba5c1ecfa…9c80585c8c6e…

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

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
A090906-001LEVETIRACETAMLEVETIRACETAM500MGTABLET / ORAL2010-11-05
A090906-002LEVETIRACETAMLEVETIRACETAM250MGTABLET / ORAL2016-10-31
A090906-003LEVETIRACETAMLEVETIRACETAM750MGTABLET / ORAL2016-10-31
A090906-004LEVETIRACETAMLEVETIRACETAM1GMTABLET / ORAL2016-10-31

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 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090906-001LEVETIRACETAM500MGTABLET / ORAL2010-11-0584e616aacf4f…
2026-09-14 22:38:342026-08A090906-002LEVETIRACETAM250MGTABLET / ORAL2016-10-3184e616aacf4f…
2026-09-14 22:38:342026-08A090906-003LEVETIRACETAM750MGTABLET / ORAL2016-10-3184e616aacf4f…
2026-09-14 22:38:342026-08A090906-004LEVETIRACETAM1GMTABLET / ORAL2016-10-3184e616aacf4f…
2026-08-18 06:07:402026-07A090906-001LEVETIRACETAM500MGTABLET / ORAL2010-11-05caaa826d4ba7…
2026-08-18 06:07:402026-07A090906-002LEVETIRACETAM250MGTABLET / ORAL2016-10-31caaa826d4ba7…
2026-08-18 06:07:402026-07A090906-003LEVETIRACETAM750MGTABLET / ORAL2016-10-31caaa826d4ba7…
2026-08-18 06:07:402026-07A090906-004LEVETIRACETAM1GMTABLET / ORAL2016-10-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090906-001LEVETIRACETAM500MGTABLET / ORAL2010-11-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090906-002LEVETIRACETAM250MGTABLET / ORAL2016-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090906-003LEVETIRACETAM750MGTABLET / ORAL2016-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090906-004LEVETIRACETAM1GMTABLET / ORAL2016-10-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090906-001LEVETIRACETAM500MGTABLET / ORAL2010-11-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090906-002LEVETIRACETAM250MGTABLET / ORAL2016-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090906-003LEVETIRACETAM750MGTABLET / ORAL2016-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090906-004LEVETIRACETAM1GMTABLET / ORAL2016-10-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090906-001LEVETIRACETAM500MGTABLET / ORAL2010-11-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090906-002LEVETIRACETAM250MGTABLET / ORAL2016-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090906-003LEVETIRACETAM750MGTABLET / ORAL2016-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090906-004LEVETIRACETAM1GMTABLET / ORAL2016-10-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090906-001LEVETIRACETAM500MGTABLET / ORAL2010-11-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090906-002LEVETIRACETAM250MGTABLET / ORAL2016-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090906-003LEVETIRACETAM750MGTABLET / ORAL2016-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090906-004LEVETIRACETAM1GMTABLET / ORAL2016-10-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090906-001LEVETIRACETAM500MGTABLET / ORAL2010-11-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090906-002LEVETIRACETAM250MGTABLET / ORAL2016-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090906-003LEVETIRACETAM750MGTABLET / ORAL2016-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090906-004LEVETIRACETAM1GMTABLET / ORAL2016-10-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090906-001LEVETIRACETAM500MGTABLET / ORAL2010-11-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090906-002LEVETIRACETAM250MGTABLET / ORAL2016-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090906-003LEVETIRACETAM750MGTABLET / ORAL2016-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090906-004LEVETIRACETAM1GMTABLET / ORAL2016-10-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090906-001LEVETIRACETAM500MGTABLET / ORAL2010-11-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090906-002LEVETIRACETAM250MGTABLET / ORAL2016-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090906-003LEVETIRACETAM750MGTABLET / ORAL2016-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090906-004LEVETIRACETAM1GMTABLET / ORAL2016-10-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090906-001LEVETIRACETAM500MGTABLET / ORAL2010-11-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090906-002LEVETIRACETAM250MGTABLET / ORAL2016-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090906-003LEVETIRACETAM750MGTABLET / ORAL2016-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090906-004LEVETIRACETAM1GMTABLET / ORAL2016-10-315bbf6a4d5a75…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-04-08 23:34 UTC2022-04A090906-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090906-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090906-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090906-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090906-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090906-004AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090906-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090906-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090906-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090906-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090906-003AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090906-004AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A090906-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A090906-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A090906-003AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A090906-004AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090906-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A090906-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A090906-003AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A090906-004AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090906-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A090906-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A090906-003AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A090906-004AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090906-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A090906-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A090906-003AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A090906-004AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A090906-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A090906-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A090906-003AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A090906-004AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090906-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A090906-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A090906-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A090906-004AB1ea99ee380514…

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13811-621-12EA - Each13811-621a2572a4d-1dd1-4afe-8822-4195a9d1dede12013-02-13
13811-621-50EA - Each13811-621a6246ef6-747a-49a7-ae34-d24d40178a6912013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LevetiracetamACTIVE INGREDIENT44YRR34555LEVETIRACETAM TABLET, FILM COATED [TRIGEN LABORATORIES, INC.]1
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LevetiracetamACTIVE MOIETY44YRR34555LEVETIRACETAM TABLET, FILM COATED [TRIGEN LABORATORIES, INC.]1
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
Ferric Oxide YellowINACTIVE INGREDIENTEX438O2MRTLEVETIRACETAM TABLET, FILM COATED [TRIGEN LABORATORIES, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HypromellosesINACTIVE INGREDIENT3NXW29V3WOLEVETIRACETAM TABLET, FILM COATED [TRIGEN LABORATORIES, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
Lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XLEVETIRACETAM TABLET, FILM COATED [TRIGEN LABORATORIES, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
Magnesium stearateINACTIVE INGREDIENT70097M6I30LEVETIRACETAM TABLET, FILM COATED [TRIGEN LABORATORIES, INC.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ELEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
PovidonesINACTIVE INGREDIENTFZ989GH94ELEVETIRACETAM TABLET, FILM COATED [TRIGEN LABORATORIES, INC.]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4LEVETIRACETAM TABLET, FILM COATED [TRIGEN LABORATORIES, INC.]1
Starch, CornINACTIVE INGREDIENTO8232NY3SJLEVETIRACETAM TABLET, FILM COATED [TRIGEN LABORATORIES, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
Titanium dioxideINACTIVE INGREDIENT15FIX9V2JPLEVETIRACETAM TABLET, FILM COATED [TRIGEN LABORATORIES, INC.]1
TRIACETININACTIVE INGREDIENTXHX3C3X673LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TriacetinINACTIVE INGREDIENTXHX3C3X673LEVETIRACETAM TABLET, FILM COATED [TRIGEN LABORATORIES, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311289levETIRAcetam 500 MG Oral TabletPSN22c76938-be1b-4754-9beb-cfecb3afd5b81
311289levetiracetam 500 MG Oral TabletSCD22c76938-be1b-4754-9beb-cfecb3afd5b81