Keppra

Product NDC
70518-2109
11-digit product format
705182109
Labeler code
70518
Product ID
70518-2109_97230079-78b7-ea23-e053-2a95a90a58f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levetiracetam
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
NDA022285
Marketing category
NDA
Marketing start
2019-05-23
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70518-2109DDiscontinued by firm2026-08-07
excluded packagepackage70518-210970518-2109-0DDiscontinued by firm2026-08-07

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 · 22 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 packagepackage70518-2109-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-2109-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-2109-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-2109-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-2109-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-2109-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-2109-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-2109-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-2109-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-2109-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-2109-0367a005e9d99…383a685ebd0f…

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

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
N022285-001KEPPRA XRLEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALABRLD2008-09-12
N022285-002KEPPRA XRLEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-02-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N022285-001AB
N022285-002AB

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022285-00178581222028-09-17Drug product2011-01-07
N022285-00278581222028-09-17Drug product

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022285-001KEPPRA XR500MGTABLET, EXTENDED RELEASE / ORALABRLD2008-09-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022285-002KEPPRA XR750MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-02-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022285-001KEPPRA XR500MGTABLET, EXTENDED RELEASE / ORALABRLD2008-09-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022285-002KEPPRA XR750MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-02-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08N022285-001KEPPRA XR500MGTABLET, EXTENDED RELEASE / ORALABRLD2008-09-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022285-002KEPPRA XR750MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-02-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022285-001KEPPRA XR500MGTABLET, EXTENDED RELEASE / ORALABRLD2008-09-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022285-002KEPPRA XR750MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-02-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022285-001KEPPRA XR500MGTABLET, EXTENDED RELEASE / ORALABRLD2008-09-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022285-002KEPPRA XR750MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-02-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022285-001KEPPRA XR500MGTABLET, EXTENDED RELEASE / ORALABRLD2008-09-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022285-002KEPPRA XR750MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-02-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022285-001KEPPRA XR500MGTABLET, EXTENDED RELEASE / ORALABRLD2008-09-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022285-002KEPPRA XR750MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-02-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022285-001KEPPRA XR500MGTABLET, EXTENDED RELEASE / ORALABRLD2008-09-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022285-002KEPPRA XR750MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-02-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022285-001KEPPRA XR500MGTABLET, EXTENDED RELEASE / ORALABRLD2008-09-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022285-002KEPPRA XR750MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-02-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022285-001KEPPRA XR500MGTABLET, EXTENDED RELEASE / ORALABRLD2008-09-12d06236e962d9…
2024-10-29 15:01 UTC2024-10N022285-002KEPPRA XR750MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-02-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022285-001KEPPRA XR500MGTABLET, EXTENDED RELEASE / ORALABRLD2008-09-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022285-002KEPPRA XR750MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-02-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022285-001KEPPRA XR500MGTABLET, EXTENDED RELEASE / ORALABRLD2008-09-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022285-002KEPPRA XR750MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-02-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022285-001KEPPRA XR500MGTABLET, EXTENDED RELEASE / ORALABRLD2008-09-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022285-002KEPPRA XR750MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-02-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022285-001KEPPRA XR500MGTABLET, EXTENDED RELEASE / ORALABRLD2008-09-128072bd15b7f6…
2024-05-31 18:47 UTC2024-05N022285-002KEPPRA XR750MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-02-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022285-001KEPPRA XR500MGTABLET, EXTENDED RELEASE / ORALABRLD2008-09-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022285-002KEPPRA XR750MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-02-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022285-001KEPPRA XR500MGTABLET, EXTENDED RELEASE / ORALABRLD2008-09-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022285-002KEPPRA XR750MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-02-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022285-001KEPPRA XR500MGTABLET, EXTENDED RELEASE / ORALABRLD2008-09-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N022285-002KEPPRA XR750MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-02-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022285-001KEPPRA XR500MGTABLET, EXTENDED RELEASE / ORALABRLD2008-09-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022285-002KEPPRA XR750MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-02-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022285-001KEPPRA XR500MGTABLET, EXTENDED RELEASE / ORALABRLD2008-09-12bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N022285-002KEPPRA XR750MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-02-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022285-001KEPPRA XR500MGTABLET, EXTENDED RELEASE / ORALABRLD2008-09-12782e0a99824c…
2021-12-28 21:50 UTC2021-12N022285-002KEPPRA XR750MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2009-02-12782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N022285-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022285-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022285-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022285-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N022285-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022285-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022285-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022285-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022285-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022285-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022285-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022285-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022285-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022285-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022285-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022285-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022285-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022285-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022285-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N022285-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022285-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022285-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022285-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022285-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022285-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022285-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022285-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N022285-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022285-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022285-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022285-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022285-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022285-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N022285-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022285-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022285-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022285-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N022285-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022285-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N022285-002AB1782e0a99824c…

Observed Orange Book patent history#

Patent history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022285-00178581222028-09-17Drug product2011-01-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022285-00278581222028-09-17Drug product011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022285-00178581222028-09-17Drug product2011-01-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022285-00278581222028-09-17Drug product31067a03dcf5…
2025-08-23 18:47 UTC2025-08N022285-00178581222028-09-17Drug product2011-01-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022285-00278581222028-09-17Drug product6a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022285-00178581222028-09-17Drug product2011-01-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022285-00278581222028-09-17Drug productfd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022285-00178581222028-09-17Drug product2011-01-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022285-00278581222028-09-17Drug productb8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022285-00178581222028-09-17Drug product2011-01-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022285-00278581222028-09-17Drug product03ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022285-00178581222028-09-17Drug product2011-01-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022285-00278581222028-09-17Drug product2680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022285-00178581222028-09-17Drug product2011-01-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022285-00278581222028-09-17Drug product5bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022285-00178581222028-09-17Drug product2011-01-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022285-00278581222028-09-17Drug productd8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022285-00178581222028-09-17Drug product2011-01-07d06236e962d9…
2024-10-29 15:01 UTC2024-10N022285-00278581222028-09-17Drug productd06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022285-00178581222028-09-17Drug product2011-01-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022285-00278581222028-09-17Drug product79d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022285-00178581222028-09-17Drug product2011-01-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022285-00278581222028-09-17Drug product301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022285-00178581222028-09-17Drug product2011-01-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022285-00278581222028-09-17Drug product1e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022285-00178581222028-09-17Drug product2011-01-078072bd15b7f6…
2024-05-31 18:47 UTC2024-05N022285-00278581222028-09-17Drug product8072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022285-00178581222028-09-17Drug product2011-01-075c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022285-00278581222028-09-17Drug product5c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022285-00178581222028-09-17Drug product2011-01-075d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022285-00278581222028-09-17Drug product5d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022285-00178581222028-09-17Drug product2011-01-074b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N022285-00278581222028-09-17Drug product4b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022285-00178581222028-09-17Drug product2011-01-0774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022285-00278581222028-09-17Drug product74a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022285-00178581222028-09-17Drug product2011-01-07bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N022285-00278581222028-09-17Drug productbb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022285-00178581222028-09-17Drug product2011-01-07782e0a99824c…
2021-12-28 21:50 UTC2021-12N022285-00278581222028-09-17Drug product782e0a99824c…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Keppra XRLEVETIRACETAMUCB, Inc.2919e43b-69a8-434c-a2d2-1f3ecd7554c02025-06-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 022285
application number: NDA022285