Levetiracetam

Product NDC: 72189-679
11-digit product format: 721890679
Labeler code: 72189
Product ID: 72189-679_5a0b3be8-fe4c-22ca-e063-6294a90a7cf2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levetiracetam
Dosage form: TABLET
Route: ORAL
Labeler: Direct_Rx
Application: ANDA091491
Marketing category: ANDA
Marketing start: 2026-06-25
Substance: LEVETIRACETAM
Active strength: 1000 mg/1
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEVETIRACETAM	1000 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
387003	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
5517b148-1eff-6421-e063-6394a90a9498	Available on FDA.report

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 ndc (product): 72189-679
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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72189-679-60	72189067960	60 TABLET in 1 BOTTLE (72189-679-60)	60 tablet	2026-06-25	No	No	Current
72189-679-82	72189067982	180 TABLET in 1 BOTTLE (72189-679-82)	180 tablet	2026-06-25	No	No	Current