Levetiracetam

Product NDC
16729-067
11-digit product format
167290067
Labeler code
16729
Product ID
16729-067_aef10601-69ca-9fd8-e053-2995a90a18e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Accord Healthcare Inc.
Application
ANDA090843
Marketing category
ANDA
Marketing start
2013-05-31
Marketing end
0000-00-00
Substance
LEVETIRACETAM
Active strength
1000 mg/1
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct16729-067DDiscontinued by firm2026-10-05
excluded packagepackage16729-06716729-067-10DDiscontinued by firm2026-10-05
excluded packagepackage16729-06716729-067-12DDiscontinued by firm2026-10-05
excluded packagepackage16729-06716729-067-16DDiscontinued by firm2026-10-05

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 · 48 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 packagepackage16729-067-16d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage16729-067-12d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage16729-067-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage16729-067-16f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage16729-067-12f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage16729-067-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage16729-067-162ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage16729-067-122ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage16729-067-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage16729-067-16a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage16729-067-12a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage16729-067-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage16729-067-16cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage16729-067-12cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage16729-067-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage16729-067-16cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage16729-067-12cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage16729-067-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage16729-067-16302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage16729-067-12302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage16729-067-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage16729-067-16ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage16729-067-12ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage16729-067-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage16729-067-160efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage16729-067-120efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage16729-067-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage16729-067-16ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage16729-067-12ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage16729-067-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage16729-067-16367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage16729-067-12367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage16729-067-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage16729-067-16557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage16729-067-12557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage16729-067-10557ba5c1ecfa…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
A090843-001LEVETIRACETAMLEVETIRACETAM250MGTABLET / ORAL2011-02-14
A090843-002LEVETIRACETAMLEVETIRACETAM500MGTABLET / ORAL2011-02-14
A090843-003LEVETIRACETAMLEVETIRACETAM750MGTABLET / ORAL2011-02-14
A090843-004LEVETIRACETAMLEVETIRACETAM1GMTABLET / ORAL2011-02-14

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 22:38:342026-08A090843-001LEVETIRACETAM250MGTABLET / ORAL2011-02-1484e616aacf4f…
2026-09-14 22:38:342026-08A090843-002LEVETIRACETAM500MGTABLET / ORAL2011-02-1484e616aacf4f…
2026-09-14 22:38:342026-08A090843-003LEVETIRACETAM750MGTABLET / ORAL2011-02-1484e616aacf4f…
2026-09-14 22:38:342026-08A090843-004LEVETIRACETAM1GMTABLET / ORAL2011-02-1484e616aacf4f…
2026-08-18 06:07:402026-07A090843-001LEVETIRACETAM250MGTABLET / ORAL2011-02-14caaa826d4ba7…
2026-08-18 06:07:402026-07A090843-002LEVETIRACETAM500MGTABLET / ORAL2011-02-14caaa826d4ba7…
2026-08-18 06:07:402026-07A090843-003LEVETIRACETAM750MGTABLET / ORAL2011-02-14caaa826d4ba7…
2026-08-18 06:07:402026-07A090843-004LEVETIRACETAM1GMTABLET / ORAL2011-02-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090843-001LEVETIRACETAM250MGTABLET / ORAL2011-02-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090843-002LEVETIRACETAM500MGTABLET / ORAL2011-02-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090843-003LEVETIRACETAM750MGTABLET / ORAL2011-02-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090843-004LEVETIRACETAM1GMTABLET / ORAL2011-02-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090843-001LEVETIRACETAM250MGTABLET / ORAL2011-02-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090843-002LEVETIRACETAM500MGTABLET / ORAL2011-02-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090843-003LEVETIRACETAM750MGTABLET / ORAL2011-02-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090843-004LEVETIRACETAM1GMTABLET / ORAL2011-02-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A090843-001LEVETIRACETAM250MGTABLET / ORAL2011-02-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090843-002LEVETIRACETAM500MGTABLET / ORAL2011-02-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090843-003LEVETIRACETAM750MGTABLET / ORAL2011-02-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090843-004LEVETIRACETAM1GMTABLET / ORAL2011-02-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090843-001LEVETIRACETAM250MGTABLET / ORAL2011-02-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090843-002LEVETIRACETAM500MGTABLET / ORAL2011-02-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090843-003LEVETIRACETAM750MGTABLET / ORAL2011-02-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090843-004LEVETIRACETAM1GMTABLET / ORAL2011-02-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090843-001LEVETIRACETAM250MGTABLET / ORAL2011-02-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090843-002LEVETIRACETAM500MGTABLET / ORAL2011-02-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090843-003LEVETIRACETAM750MGTABLET / ORAL2011-02-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090843-004LEVETIRACETAM1GMTABLET / ORAL2011-02-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090843-001LEVETIRACETAM250MGTABLET / ORAL2011-02-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090843-002LEVETIRACETAM500MGTABLET / ORAL2011-02-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090843-003LEVETIRACETAM750MGTABLET / ORAL2011-02-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090843-004LEVETIRACETAM1GMTABLET / ORAL2011-02-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090843-001LEVETIRACETAM250MGTABLET / ORAL2011-02-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090843-002LEVETIRACETAM500MGTABLET / ORAL2011-02-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090843-003LEVETIRACETAM750MGTABLET / ORAL2011-02-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090843-004LEVETIRACETAM1GMTABLET / ORAL2011-02-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090843-001LEVETIRACETAM250MGTABLET / ORAL2011-02-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090843-002LEVETIRACETAM500MGTABLET / ORAL2011-02-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090843-003LEVETIRACETAM750MGTABLET / ORAL2011-02-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090843-004LEVETIRACETAM1GMTABLET / ORAL2011-02-145bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 108 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-05-31 18:47 UTC2024-05A090843-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090843-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090843-003AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090843-004AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090843-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090843-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090843-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090843-004AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090843-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090843-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090843-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090843-004AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090843-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090843-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090843-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090843-004AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090843-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090843-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090843-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090843-004AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090843-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090843-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090843-003AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090843-004AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090843-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090843-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090843-003AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090843-004AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090843-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090843-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090843-003AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090843-004AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A090843-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A090843-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A090843-003AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A090843-004AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090843-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A090843-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A090843-003AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A090843-004AB18869cabd3fbd…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
76e81f18-c6b9-f226-530a-a6296d5cd5f4Product name620251106
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
087c9486-f4a9-a565-c6fb-d6fa49f4572aProduct name620230317
525a8d4d-1988-fc3f-e292-27fd384de4f0Product name820230104
32b651f8-caa7-6882-11c7-54c4ad21796bProduct name820201216
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
ce453ca5-90cf-41ed-9de4-de519f70a0f2Product name220160303
66666eb8-1fa6-4a60-bae9-e564e73b4cd5Product name120150728
eecbc0ef-ab5c-4ff9-8aaa-6ea73ee46477Product name120150410
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-067-12EA - Each16729-0679d3ecad4-75fc-41c7-8cb7-0a0d8599b29812013-08-02

DailyMed Socrata Ingredients#

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387003levETIRAcetam 1000 MG Oral TabletPSN9329702d-ffda-4e80-b3b2-8eca403e569f4
387003levetiracetam 1000 MG Oral TabletSCD9329702d-ffda-4e80-b3b2-8eca403e569f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-067-121672900671260 TABLET, FILM COATED in 1 BOTTLE (16729-067-12) 2013-05-310000-00-00NoNoCurrent