Levetiracetam

Product NDC: 42291-387
11-digit product format: 422910387
Labeler code: 42291
Product ID: 42291-387_639ecbfc-5070-680b-e053-2991aa0adb10
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levetiracetam
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: AvKARE, Inc.
Application: ANDA202167
Marketing category: ANDA
Marketing start: 2016-07-28
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	42291-387		D	Discontinued by firm		2026-08-07
excluded package	package	42291-387	42291-387-60	D	Discontinued by firm		2026-08-07

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 · 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	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42291-387-60	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42291-387-60	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42291-387-60	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42291-387-60	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42291-387-60	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42291-387-60	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42291-387-60	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42291-387-60	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42291-387-60	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42291-387-60	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42291-387-60	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42291-387-60	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	42291-387-60	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	42291-387-60	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	42291-387-60	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202167-001	LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL			2015-09-04
A202167-002	LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL			2015-09-04

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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202167-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202167-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202167-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202167-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202167-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202167-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202167-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202167-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202167-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202167-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202167-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202167-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202167-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202167-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202167-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202167-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202167-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202167-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202167-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202167-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202167-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202167-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202167-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202167-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202167-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202167-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202167-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202167-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202167-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202167-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202167-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202167-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202167-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202167-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202167-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202167-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202167-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202167-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202167-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-04	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202167-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-04	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202167-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202167-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202167-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202167-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202167-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202167-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202167-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202167-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202167-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202167-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202167-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202167-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202167-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202167-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202167-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A202167-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202167-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A202167-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202167-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A202167-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202167-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202167-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202167-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202167-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202167-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A202167-002	AB	1	`ea99ee380514…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202167-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202167-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202167-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A202167-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202167-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A202167-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202167-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202167-002	AB	1	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42291-387-60	2023-01-03	C162847	48780-1	d6a99b39-9cca-a426-e053-dadaa90af4c2	Levitiracetam Extended-release Tablets USP These highlights do not include all the information needed to use levetiracetam extended-release tablets safely and effectively. See full prescribing information for levetiracetam extended-release tablets . LEVETIRACETAM extended-release tablets USP , for oral use Initial U.S. Approval: 1999
42291-387-60	2022-01-28	C162847	48780-1	d6a99b39-9cca-a426-e053-dadaa90af4c2	Levitiracetam Extended-release Tablets USP These highlights do not include all the information needed to use levetiracetam extended-release tablets safely and effectively. See full prescribing information for levetiracetam extended-release tablets . LEVETIRACETAM extended-release tablets USP , for oral use Initial U.S. Approval: 1999

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-387-60	EA - Each	42291-387	ea56978e-592f-4e47-9939-63487d02d62d	1	2016-09-02

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
42291-387-60	42291038760	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-387-60)	2016-07-28	0000-00-00	No	No	Current