Levetiracetam ER

Product NDC: 72189-510
11-digit product format: 721890510
Labeler code: 72189
Product ID: 72189-510_2c4e5941-7089-8be7-e063-6394a90a92e3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levetiracetam ER
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Direct_Rx
Application: ANDA203468
Marketing category: ANDA
Marketing start: 2023-08-25
Substance: LEVETIRACETAM
Active strength: 500 mg/1
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 4 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
2025-01-20 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	72189-510-60	`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	72189-510-60	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A203468-001	LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-05-21
A203468-002	LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-05-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203468-001	AB
A203468-002	AB

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 · 86 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
2026-09-14 22:38:34	2026-08	A203468-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203468-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203468-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203468-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203468-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203468-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203468-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203468-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203468-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203468-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203468-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203468-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203468-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203468-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203468-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203468-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203468-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203468-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203468-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203468-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203468-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203468-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203468-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203468-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203468-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203468-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203468-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203468-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203468-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203468-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203468-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203468-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203468-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203468-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203468-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203468-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203468-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203468-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203468-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203468-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A203468-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203468-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203468-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203468-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203468-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203468-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203468-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203468-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203468-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203468-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203468-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203468-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203468-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203468-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203468-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203468-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203468-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203468-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203468-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203468-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203468-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203468-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203468-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203468-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203468-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203468-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203468-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203468-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203468-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203468-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203468-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203468-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203468-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203468-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203468-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203468-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203468-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203468-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203468-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203468-002	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Levetiracetam ER
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEVETIRACETAM	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
44YRR34555	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
807832	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
03c449a1-9b40-a7da-e063-6394a90a984e	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72189-510-60	Levetiracetam ER	60 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	60		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-510-60	EA - Each	72189-510	f08f2ddf-16ec-4858-9607-a60cade5c751	1	2023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-510	LEVETIRACETAM ER TABLET, FILM COATED, EXTENDED RELEASE [DIRECT_RX]	2	Current NDC, 1 package rows	20250123_03c449a1-9b40-a7da-e063-6394a90a984e.zip

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LEVETIRACETAM	LEVETIRACETAM	REMEDYREPACK INC.	9bdef24b-c50e-4e6a-8650-59d78009f472	2026-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203468 application number: ANDA203468
LEVETIRACETAM	LEVETIRACETAM	REMEDYREPACK INC.	17969eda-4c85-40a0-9a94-7e4675adf910	2026-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203468 application number: ANDA203468
LEVETIRACETAM	LEVETIRACETAM	Bryant Ranch Prepack	ace53552-d616-45e8-9f99-2f0041d0b430	2026-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203468 application number: ANDA203468
Levetiracetam ER	LEVETIRACETAM ER	Direct_Rx	03c449a1-9b40-a7da-e063-6394a90a984e	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203468 application number: ANDA203468 ndc (product): 72189-510
LEVETIRACETAM	LEVETIRACETAM	Solco healthcare U.S., LLC	bc8644ed-3320-47b5-adf3-8b972bea8abd	2024-03-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203468 application number: ANDA203468

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
807832	levETIRAcetam 500 MG 24HR Extended Release Oral Tablet	PSN	03c449a1-9b40-a7da-e063-6394a90a984e	2
807832	24 HR levetiracetam 500 MG Extended Release Oral Tablet	SCD	03c449a1-9b40-a7da-e063-6394a90a984e	2
807832	levetiracetam 500 MG 24 HR Extended Release Oral Tablet	SY	03c449a1-9b40-a7da-e063-6394a90a984e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72189-510-60	72189051060	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72189-510-60)	2023-08-25	No	No	Current