Levetiracetam

Product NDC: 80425-0566
Requested package NDC: 80425-0566-3
11-digit product format: 804250566
Labeler code: 80425
Product ID: 80425-0566_45a04c5b-7c31-19bf-e063-6294a90aad27
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levetiracetam
Dosage form: TABLET
Route: ORAL
Labeler: Advanced Rx of Tennessee, LLC
Application: ANDA091491
Marketing category: ANDA
Marketing start: 2025-12-10
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

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	TE codes	Approval date
A091491-001	LEVETIRACETAM	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2010-12-14
A091491-002	LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2010-12-14
A091491-003	LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2010-12-14
A091491-004	LEVETIRACETAM	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-12-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A091491-001	AB
A091491-002	AB
A091491-003	AB
A091491-004	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 5 · 172 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	A091491-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2010-12-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091491-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2010-12-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091491-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2010-12-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091491-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-12-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091491-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2010-12-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091491-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2010-12-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091491-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2010-12-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091491-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-12-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091491-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2010-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091491-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2010-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091491-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2010-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091491-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091491-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2010-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091491-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2010-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091491-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2010-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091491-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-12-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091491-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2010-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091491-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2010-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091491-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2010-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091491-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-12-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091491-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2010-12-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091491-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2010-12-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091491-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2010-12-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091491-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-12-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091491-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2010-12-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091491-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2010-12-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091491-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2010-12-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091491-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-12-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091491-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2010-12-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091491-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2010-12-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091491-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2010-12-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091491-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091491-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2010-12-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091491-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2010-12-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091491-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2010-12-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091491-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091491-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2010-12-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091491-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2010-12-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091491-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2010-12-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091491-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-12-14	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 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	A091491-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091491-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091491-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091491-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091491-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091491-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091491-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091491-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091491-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091491-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091491-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091491-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091491-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091491-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091491-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091491-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091491-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091491-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091491-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091491-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091491-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091491-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091491-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091491-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091491-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091491-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091491-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091491-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091491-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091491-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091491-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091491-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091491-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091491-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091491-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091491-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091491-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091491-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091491-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091491-004	AB	1	`5bbf6a4d5a75…`

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
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
311289	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
45a07f44-078d-0513-e063-6394a90a1629	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
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
80425-0566-1	Levetiracetam	120 in 1 BOTTLE	TABLET	120	1
80425-0566-2	Levetiracetam	30 in 1 BOTTLE	TABLET	30	1
80425-0566-3	Levetiracetam	60 in 1 BOTTLE	TABLET	60	1
80425-0566-4	Levetiracetam	90 in 1 BOTTLE	TABLET	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0566-1	EA - Each	80425-0566	4ca41aa7-2654-4b03-90cf-f3a3fe3f46d2	1	2026-01-08
80425-0566-2	EA - Each	80425-0566	edcb2463-2ad3-43e4-9d06-819e50300f3e	1	2026-01-08
80425-0566-3	EA - Each	80425-0566	9fcb051a-cb95-4d54-9fcc-3ded20b62add	1	2026-01-08
80425-0566-4	EA - Each	80425-0566	2174dc95-f629-4e7f-951b-7055705acde9	1	2026-01-08

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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levetiracetam	LEVETIRACETAM	REMEDYREPACK INC.	2d307850-0ed5-4f32-ac62-0e1e2fe27a7a	2026-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091491 application number: ANDA091491
Levetiracetam	LEVETIRACETAM	Direct_Rx	5517b148-1eff-6421-e063-6394a90a9498	2026-08-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091491 application number: ANDA091491
Levetiracetam	LEVETIRACETAM	Coupler LLC	266d4ead-fda2-f030-e063-6394a90a68e2	2026-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091491 application number: ANDA091491
Levetiracetam	LEVETIRACETAM	REMEDYREPACK INC.	a05bbfa4-c34f-4134-8207-db79e4c70445	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091491 application number: ANDA091491
Levetiracetam	LEVETIRACETAM	REMEDYREPACK INC.	23073db5-3fc4-4051-a22d-e49a63e42647	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091491 application number: ANDA091491
Levetiracetam	LEVETIRACETAM	REMEDYREPACK INC.	c12d8af3-39a8-4690-8d47-43dec70b7579	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091491 application number: ANDA091491
Levetiracetam	LEVETIRACETAM	Bryant Ranch Prepack	c4a3018a-3cd8-4e07-a840-099ceae01c91	2026-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091491 application number: ANDA091491
Levetiracetam	LEVETIRACETAM	ASCLEMED USA INC.	a3c57d82-511c-4c7d-84ff-f791f931f576	2026-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091491 application number: ANDA091491
Levetiracetam	LEVETIRACETAM	Coupler LLC	513f422f-1637-5f41-e063-6294a90ab548	2026-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091491 application number: ANDA091491
Levetiracetam	LEVETIRACETAM	Bryant Ranch Prepack	7696961e-dfff-422a-b72f-e31ceeac10af	2026-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091491 application number: ANDA091491
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	deca634a-651e-4c70-9fc3-b0087b537b0a	2025-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091491 application number: ANDA091491
Levetiracetam	LEVETIRACETAM	Cranbury Pharmaceuticals, LLC	b1e988f7-8bbe-4ef4-8b0a-b2a8af8a482b	2025-12-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091491 application number: ANDA091491
Levetiracetam	LEVETIRACETAM	Advanced Rx of Tennessee, LLC	45a07f44-078d-0513-e063-6394a90a1629	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091491 application number: ANDA091491 ndc (package): 80425-0566-3 ndc (product): 80425-0566 ndc11 (package): 80425056603
Levetiracetam	LEVETIRACETAM	Advanced Rx of Tennessee, LLC	45a03a43-04db-9138-e063-6394a90a12fa	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091491 application number: ANDA091491
Levetiracetam	LEVETIRACETAM	Preferred Pharmaceuticals Inc.	8c16bc7b-672c-420a-a457-350060533375	2025-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091491 application number: ANDA091491
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	c82313cb-744f-45ef-b74c-1bdd055b2193	2025-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091491 application number: ANDA091491
Levetiracetam	LEVETIRACETAM	Coupler LLC	2d596153-c49b-273f-e063-6294a90ac663	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091491 application number: ANDA091491

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
311289	levETIRAcetam 500 MG Oral Tablet	PSN	45a07f44-078d-0513-e063-6394a90a1629	1
311289	levetiracetam 500 MG Oral Tablet	SCD	45a07f44-078d-0513-e063-6394a90a1629	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
80425-0566-3	80425056603	60 TABLET in 1 BOTTLE (80425-0566-3)	60 tablet	2025-12-10	No	No	Current