Levetiracetam

Product NDC: 50090-3264
11-digit product format: 500903264
Labeler code: 50090
Product ID: 50090-3264_e5e6cad4-6e7f-413c-a281-e213670b4bd5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: levetiracetam
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50090-3264		I	Inactivated by FDA		2026-10-05
excluded package	package	50090-3264	50090-3264-0	I	Inactivated by FDA		2026-10-05

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-3264-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-3264-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-3264-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-3264-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-3264-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-3264-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-3264-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-3264-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-3264-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50090-3264-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-3264-0	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-3264-0	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-3264-0	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-3264-0	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-3264-0	`1332a3947898…`	`d4bfe170f9cd…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A090843-001	LEVETIRACETAM	LEVETIRACETAM	250MG	TABLET / ORAL	2011-02-14
A090843-002	LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET / ORAL	2011-02-14
A090843-003	LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET / ORAL	2011-02-14
A090843-004	LEVETIRACETAM	LEVETIRACETAM	1GM	TABLET / ORAL	2011-02-14

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A090843-001	LEVETIRACETAM	250MG	TABLET / ORAL	2011-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090843-002	LEVETIRACETAM	500MG	TABLET / ORAL	2011-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090843-003	LEVETIRACETAM	750MG	TABLET / ORAL	2011-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090843-004	LEVETIRACETAM	1GM	TABLET / ORAL	2011-02-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090843-001	LEVETIRACETAM	250MG	TABLET / ORAL	2011-02-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090843-002	LEVETIRACETAM	500MG	TABLET / ORAL	2011-02-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090843-003	LEVETIRACETAM	750MG	TABLET / ORAL	2011-02-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090843-004	LEVETIRACETAM	1GM	TABLET / ORAL	2011-02-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090843-001	LEVETIRACETAM	250MG	TABLET / ORAL	2011-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090843-002	LEVETIRACETAM	500MG	TABLET / ORAL	2011-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090843-003	LEVETIRACETAM	750MG	TABLET / ORAL	2011-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090843-004	LEVETIRACETAM	1GM	TABLET / ORAL	2011-02-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090843-001	LEVETIRACETAM	250MG	TABLET / ORAL	2011-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090843-002	LEVETIRACETAM	500MG	TABLET / ORAL	2011-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090843-003	LEVETIRACETAM	750MG	TABLET / ORAL	2011-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090843-004	LEVETIRACETAM	1GM	TABLET / ORAL	2011-02-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090843-001	LEVETIRACETAM	250MG	TABLET / ORAL	2011-02-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090843-002	LEVETIRACETAM	500MG	TABLET / ORAL	2011-02-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090843-003	LEVETIRACETAM	750MG	TABLET / ORAL	2011-02-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090843-004	LEVETIRACETAM	1GM	TABLET / ORAL	2011-02-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090843-001	LEVETIRACETAM	250MG	TABLET / ORAL	2011-02-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090843-002	LEVETIRACETAM	500MG	TABLET / ORAL	2011-02-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090843-003	LEVETIRACETAM	750MG	TABLET / ORAL	2011-02-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090843-004	LEVETIRACETAM	1GM	TABLET / ORAL	2011-02-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090843-001	LEVETIRACETAM	250MG	TABLET / ORAL	2011-02-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090843-002	LEVETIRACETAM	500MG	TABLET / ORAL	2011-02-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090843-003	LEVETIRACETAM	750MG	TABLET / ORAL	2011-02-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090843-004	LEVETIRACETAM	1GM	TABLET / ORAL	2011-02-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090843-001	LEVETIRACETAM	250MG	TABLET / ORAL	2011-02-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090843-002	LEVETIRACETAM	500MG	TABLET / ORAL	2011-02-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090843-003	LEVETIRACETAM	750MG	TABLET / ORAL	2011-02-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090843-004	LEVETIRACETAM	1GM	TABLET / ORAL	2011-02-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090843-001	LEVETIRACETAM	250MG	TABLET / ORAL	2011-02-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090843-002	LEVETIRACETAM	500MG	TABLET / ORAL	2011-02-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090843-003	LEVETIRACETAM	750MG	TABLET / ORAL	2011-02-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090843-004	LEVETIRACETAM	1GM	TABLET / ORAL	2011-02-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090843-001	LEVETIRACETAM	250MG	TABLET / ORAL	2011-02-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090843-002	LEVETIRACETAM	500MG	TABLET / ORAL	2011-02-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090843-003	LEVETIRACETAM	750MG	TABLET / ORAL	2011-02-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090843-004	LEVETIRACETAM	1GM	TABLET / ORAL	2011-02-14	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-05-31 18:47 UTC	2024-05	A090843-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090843-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090843-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090843-004	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090843-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090843-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090843-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090843-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090843-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090843-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090843-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090843-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090843-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090843-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090843-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090843-004	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090843-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090843-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090843-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090843-004	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090843-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090843-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090843-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090843-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090843-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090843-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090843-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090843-004	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090843-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090843-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090843-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090843-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090843-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090843-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090843-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090843-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090843-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090843-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090843-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090843-004	AB	1	`8869cabd3fbd…`

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 concept	Relation	Version	Effective
76e81f18-c6b9-f226-530a-a6296d5cd5f4	Product name	6	20251106
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
087c9486-f4a9-a565-c6fb-d6fa49f4572a	Product name	6	20230317
525a8d4d-1988-fc3f-e292-27fd384de4f0	Product name	8	20230104
32b651f8-caa7-6882-11c7-54c4ad21796b	Product name	8	20201216
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
ce453ca5-90cf-41ed-9de4-de519f70a0f2	Product name	2	20160303
66666eb8-1fa6-4a60-bae9-e564e73b4cd5	Product name	1	20150728
eecbc0ef-ab5c-4ff9-8aaa-6ea73ee46477	Product name	1	20150410
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-3264-0	2023-01-30	C162847	48780-1	f386c649-f0a4-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use LEVETIRACETAM safely and effectively. See full prescribing information for LEVETIRACETAM. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-3264-0	Levetiracetam	30 in 1 BOTTLE	TABLET, FILM COATED	30		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-3264-0	EA - Each	50090-3264	cb978ccc-ca03-4d42-a725-651ad8f1afc1	1	2019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-3264	LEVETIRACETAM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]	4	Legacy NDC, 1 package rows	20200122_9329702d-ffda-4e80-b3b2-8eca403e569f.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
44YRR34555	LEVETIRACETAM	102767-28-2	LEVETIRACETAM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
387003	levETIRAcetam 1000 MG Oral Tablet	PSN	9329702d-ffda-4e80-b3b2-8eca403e569f	4
387003	levetiracetam 1000 MG Oral Tablet	SCD	9329702d-ffda-4e80-b3b2-8eca403e569f	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-3264-0	50090326400	30 TABLET, FILM COATED in 1 BOTTLE (50090-3264-0)	2017-11-14	0000-00-00	No	No	Current