Levetiracetam

Product NDC: 43489-122
11-digit product format: 434890122
Labeler code: 43489
Product ID: 43489-122_b9ca151f-094c-1c00-e053-2a95a90a0f86
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: levetiracetam
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: China Resources Saike Pharmaceutical Co., Ltd.
Application: ANDA205102
Marketing category: ANDA
Marketing start: 2016-08-15
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: 2022-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43489-122		I	Inactivated by FDA	2026-08-10
excluded package	package	43489-122	43489-122-05	I	Inactivated by FDA	2026-08-10
excluded package	package	43489-122	43489-122-09	I	Inactivated by FDA	2026-08-10

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 · 45 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	43489-122-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43489-122-05	`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	43489-122-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43489-122-05	`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	43489-122-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43489-122-05	`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	43489-122-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43489-122-05	`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	43489-122-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43489-122-05	`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	43489-122-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43489-122-05	`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	43489-122-09	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43489-122-05	`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	43489-122-09	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43489-122-05	`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	43489-122-09	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43489-122-05	`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	43489-122-09	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43489-122-05	`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	43489-122-09	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43489-122-05	`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	43489-122-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43489-122-05	`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	43489-122-09	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	43489-122-05	`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	43489-122-09	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	43489-122-05	`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	43489-122-09	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	43489-122-05	`1332a3947898…`	`d4bfe170f9cd…`

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
A205102-003	LEVETIRACETAM	LEVETIRACETAM	1GM	TABLET / ORAL			2015-12-16
A205102-004	LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET / ORAL			2015-12-16

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	A205102-003	LEVETIRACETAM	1GM	TABLET / ORAL		2015-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205102-004	LEVETIRACETAM	500MG	TABLET / ORAL		2015-12-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205102-003	LEVETIRACETAM	1GM	TABLET / ORAL		2015-12-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205102-004	LEVETIRACETAM	500MG	TABLET / ORAL		2015-12-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205102-003	LEVETIRACETAM	1GM	TABLET / ORAL		2015-12-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205102-004	LEVETIRACETAM	500MG	TABLET / ORAL		2015-12-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205102-003	LEVETIRACETAM	1GM	TABLET / ORAL		2015-12-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205102-004	LEVETIRACETAM	500MG	TABLET / ORAL		2015-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205102-003	LEVETIRACETAM	1GM	TABLET / ORAL		2015-12-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205102-004	LEVETIRACETAM	500MG	TABLET / ORAL		2015-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205102-003	LEVETIRACETAM	1GM	TABLET / ORAL		2015-12-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205102-004	LEVETIRACETAM	500MG	TABLET / ORAL		2015-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205102-003	LEVETIRACETAM	1GM	TABLET / ORAL		2015-12-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205102-004	LEVETIRACETAM	500MG	TABLET / ORAL		2015-12-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205102-003	LEVETIRACETAM	1GM	TABLET / ORAL		2015-12-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205102-004	LEVETIRACETAM	500MG	TABLET / ORAL		2015-12-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205102-003	LEVETIRACETAM	1GM	TABLET / ORAL		2015-12-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205102-004	LEVETIRACETAM	500MG	TABLET / ORAL		2015-12-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205102-003	LEVETIRACETAM	1GM	TABLET / ORAL		2015-12-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205102-004	LEVETIRACETAM	500MG	TABLET / ORAL		2015-12-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205102-003	LEVETIRACETAM	1GM	TABLET / ORAL		2015-12-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205102-004	LEVETIRACETAM	500MG	TABLET / ORAL		2015-12-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205102-003	LEVETIRACETAM	1GM	TABLET / ORAL		2015-12-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205102-004	LEVETIRACETAM	500MG	TABLET / ORAL		2015-12-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205102-003	LEVETIRACETAM	1GM	TABLET / ORAL		2015-12-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205102-004	LEVETIRACETAM	500MG	TABLET / ORAL		2015-12-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205102-003	LEVETIRACETAM	1GM	TABLET / ORAL		2015-12-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205102-004	LEVETIRACETAM	500MG	TABLET / ORAL		2015-12-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205102-003	LEVETIRACETAM	1GM	TABLET / ORAL		2015-12-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205102-004	LEVETIRACETAM	500MG	TABLET / ORAL		2015-12-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205102-003	LEVETIRACETAM	1GM	TABLET / ORAL		2015-12-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205102-004	LEVETIRACETAM	500MG	TABLET / ORAL		2015-12-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205102-003	LEVETIRACETAM	1GM	TABLET / ORAL		2015-12-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205102-004	LEVETIRACETAM	500MG	TABLET / ORAL		2015-12-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205102-003	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2015-12-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205102-004	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2015-12-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205102-003	LEVETIRACETAM	1GM	TABLET / ORAL		2015-12-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205102-004	LEVETIRACETAM	500MG	TABLET / ORAL		2015-12-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205102-003	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2015-12-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205102-004	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2015-12-16	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A205102-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205102-004	AB	1	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	A205102-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205102-004	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205102-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205102-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205102-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A205102-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205102-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A205102-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205102-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A205102-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205102-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A205102-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205102-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A205102-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205102-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A205102-004	AB	1	`ea99ee380514…`

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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
43489-122-05	2023-01-30	C162847	48780-1	f386c64a-36b8-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use LEVETIRACETAM TABLETS, USP, safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS, USP. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999
43489-122-09	2023-01-30	C162847	48780-1	f386c64a-36b8-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use LEVETIRACETAM TABLETS, USP, safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS, USP. 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
43489-122-05	Levetiracetam	1000 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	1000		12
43489-122-09	Levetiracetam	120 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	120		12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43489-122	LEVETIRACETAM TABLET, FILM COATED [CHINA RESOURCES SAIKE PHARMACEUTICAL CO., LTD.]	12	Legacy NDC, 2 package rows	20210127_0b3b3c98-afa4-4f61-bab0-62c4afa27757.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	0b3b3c98-afa4-4f61-bab0-62c4afa27757	12
311289	levETIRAcetam 500 MG Oral Tablet	PSN	0b3b3c98-afa4-4f61-bab0-62c4afa27757	12
387003	levetiracetam 1000 MG Oral Tablet	SCD	0b3b3c98-afa4-4f61-bab0-62c4afa27757	12
311289	levetiracetam 500 MG Oral Tablet	SCD	0b3b3c98-afa4-4f61-bab0-62c4afa27757	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43489-122-05	43489012205	1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43489-122-05)	2016-08-15	0000-00-00	No	No	Current
43489-122-09	43489012209	120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43489-122-09)	2016-08-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levetiracetam	China Resources Saike Pharmaceutical Co., Ltd.	2021-01-26	HUMAN PRESCRIPTION DRUG LABEL	12