levetiracetam

Product NDC
10370-195
Requested package NDC
10370-195-06
11-digit product format
103700195
Labeler code
10370
Product ID
10370-195_a46e7248-dd69-4781-98a2-e08646630304
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levetiracetam
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Par Pharmaceutical, Inc.
Application
ANDA091360
Marketing category
ANDA
Marketing start
2011-10-04
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
No
Listing certified through
2020-12-31
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 packagepackage10370-19510370-195-06DDiscontinued by firm2026-08-17

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 · 16 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091360-001LEVETIRACETAMLEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORAL2011-10-04
A091360-002LEVETIRACETAMLEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORAL2011-10-04

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A091360-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORAL2011-10-04caaa826d4ba7…
2026-08-18 06:07:402026-07A091360-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORAL2011-10-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091360-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORAL2011-10-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091360-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORAL2011-10-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091360-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORAL2011-10-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091360-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORAL2011-10-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A091360-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORAL2011-10-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091360-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORAL2011-10-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091360-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORAL2011-10-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091360-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORAL2011-10-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091360-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORAL2011-10-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091360-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORAL2011-10-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091360-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORAL2011-10-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091360-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORAL2011-10-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091360-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORAL2011-10-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091360-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORAL2011-10-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091360-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORAL2011-10-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091360-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORAL2011-10-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091360-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORAL2011-10-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091360-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORAL2011-10-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091360-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORAL2011-10-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A091360-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORAL2011-10-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091360-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORAL2011-10-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091360-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORAL2011-10-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091360-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORAL2011-10-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091360-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORAL2011-10-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091360-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORAL2011-10-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091360-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORAL2011-10-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091360-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORAL2011-10-048072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091360-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORAL2011-10-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091360-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-10-045c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091360-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-10-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091360-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-10-045d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091360-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-10-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091360-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-10-044b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091360-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-10-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091360-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-10-0474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091360-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-10-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091360-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-10-04bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091360-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-10-04bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 50 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091360-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091360-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091360-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091360-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091360-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091360-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091360-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091360-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091360-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091360-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091360-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A091360-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091360-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091360-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A091360-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A091360-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091360-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A091360-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091360-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A091360-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091360-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A091360-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A091360-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A091360-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A091360-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A091360-002AB1ea99ee380514…
2024-02-18 07:12 UTC2024-02A091360-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A091360-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091360-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A091360-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091360-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091360-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091360-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091360-002AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091360-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091360-002AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091360-001AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091360-002AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A091360-001AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A091360-002AB1053a50430f4f…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
10370-195-062025-01-29These highlights do not include all the information needed to use EXTENDED-RELEASE LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for EXTENDED-RELEASE LEVETIRACETAM TABLETS. Levetiracetam Extended-Release Tablets, for oral use. Initial U.S. Approval: 1999
10370-195-092025-01-29These highlights do not include all the information needed to use EXTENDED-RELEASE LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for EXTENDED-RELEASE LEVETIRACETAM TABLETS. Levetiracetam Extended-Release Tablets, for oral use. Initial U.S. Approval: 1999
10370-195-502025-01-29These highlights do not include all the information needed to use EXTENDED-RELEASE LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for EXTENDED-RELEASE LEVETIRACETAM TABLETS. Levetiracetam Extended-Release Tablets, for oral use. Initial U.S. Approval: 1999
10370-195-062022-07-29These highlights do not include all the information needed to use EXTENDED-RELEASE LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for EXTENDED-RELEASE LEVETIRACETAM TABLETS. Levetiracetam Extended-Release Tablets, for oral use. Initial U.S. Approval: 1999
10370-195-092022-07-29These highlights do not include all the information needed to use EXTENDED-RELEASE LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for EXTENDED-RELEASE LEVETIRACETAM TABLETS. Levetiracetam Extended-Release Tablets, for oral use. Initial U.S. Approval: 1999
10370-195-502022-07-29These highlights do not include all the information needed to use EXTENDED-RELEASE LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for EXTENDED-RELEASE LEVETIRACETAM TABLETS. Levetiracetam Extended-Release Tablets, for oral use. Initial U.S. Approval: 1999

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10370-195-06EA - Each10370-1954cd5b5fc-29d0-4b1e-9213-8056c06e94d912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM EXTENDED-RELEASE (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [ANCHEN PHARMACEUTICALS, INC.]5
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM EXTENDED-RELEASE (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [ANCHEN PHARMACEUTICALS, INC.]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LEVETIRACETAM EXTENDED-RELEASE (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [ANCHEN PHARMACEUTICALS, INC.]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLEVETIRACETAM EXTENDED-RELEASE (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [ANCHEN PHARMACEUTICALS, INC.]5
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PLEVETIRACETAM EXTENDED-RELEASE (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [ANCHEN PHARMACEUTICALS, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVETIRACETAM EXTENDED-RELEASE (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [ANCHEN PHARMACEUTICALS, INC.]5
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ALEVETIRACETAM EXTENDED-RELEASE (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [ANCHEN PHARMACEUTICALS, INC.]5
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990LEVETIRACETAM EXTENDED-RELEASE (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [ANCHEN PHARMACEUTICALS, INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVETIRACETAM EXTENDED-RELEASE (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [ANCHEN PHARMACEUTICALS, INC.]5
TALCINACTIVE INGREDIENT7SEV7J4R1ULEVETIRACETAM EXTENDED-RELEASE (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [ANCHEN PHARMACEUTICALS, INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVETIRACETAM EXTENDED-RELEASE (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [ANCHEN PHARMACEUTICALS, INC.]5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10370-195-061037001950660 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10370-195-06) 2011-10-040000-00-00NoNoCurrent