Levetiracetam

Product NDC: 68788-8254
Requested package NDC: 68788-8254-9
11-digit product format: 687888254
Labeler code: 68788
Product ID: 68788-8254_dbbfc67e-e438-40f9-bbee-56f0d0e25a29
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levetiracetam
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA078154
Marketing category: ANDA
Marketing start: 2022-09-02
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 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078154-001	LEVETIRACETAM	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15
A078154-002	LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15
A078154-003	LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A078154-001	AB
A078154-002	AB
A078154-003	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 4 · 123 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	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078154-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078154-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078154-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078154-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078154-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078154-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078154-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078154-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078154-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078154-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078154-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078154-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078154-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078154-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078154-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078154-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078154-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078154-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078154-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078154-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078154-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078154-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078154-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078154-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078154-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078154-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078154-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078154-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078154-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078154-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078154-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078154-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078154-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078154-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078154-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078154-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078154-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078154-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078154-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078154-001	AB	1	`8072bd15b7f6…`

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
e31c6830-4647-4481-b4f1-494a52c48b1b	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
68788-8254-1	Levetiracetam	100 in 1 BOTTLE	TABLET, FILM COATED	100	4
68788-8254-2	Levetiracetam	20 in 1 BOTTLE	TABLET, FILM COATED	20	4
68788-8254-3	Levetiracetam	30 in 1 BOTTLE	TABLET, FILM COATED	30	4
68788-8254-6	Levetiracetam	60 in 1 BOTTLE	TABLET, FILM COATED	60	4
68788-8254-9	Levetiracetam	90 in 1 BOTTLE	TABLET, FILM COATED	90	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8254-1	EA - Each	68788-8254	f724e649-31a6-4fcf-972a-642c93c80774	1	2022-10-06
68788-8254-2	EA - Each	68788-8254	b265081d-10cc-40cf-9b00-6594a4e5c2f5	1	2022-10-06
68788-8254-3	EA - Each	68788-8254	7b50e9e8-65a6-44dc-84e8-296a0ccb7e86	1	2022-10-06
68788-8254-6	EA - Each	68788-8254	8a214fc7-17ef-4146-a2b4-1f0fdba90501	1	2022-10-06
68788-8254-9	EA - Each	68788-8254	630f4653-ed7e-49be-b954-b40aaae7cf7b	1	2022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8254	LEVETIRACETAM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	3	Current NDC, Legacy NDC, 5 package rows	20240709_e31c6830-4647-4481-b4f1-494a52c48b1b.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levetiracetam	LEVETIRACETAM	REMEDYREPACK INC.	1c26c0ad-9d37-45c5-9091-849509f4fc01	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078154 application number: ANDA078154
Levetiracetam	LEVETIRACETAM	Bryant Ranch Prepack	90e01877-abcb-4697-a7ed-9afe5ee77050	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078154 application number: ANDA078154
Levetiracetam	LEVETIRACETAM	PD-Rx Pharmaceuticals, Inc.	c4b2da6a-ed50-4a54-90bd-32f76b178736	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078154 application number: ANDA078154
Levetiracetam	LEVETIRACETAM	Lupin Pharmaceuticals, Inc.	df661166-325d-4071-9bc1-f7bf992996d2	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078154 application number: ANDA078154
Levetiracetam	LEVETIRACETAM	Bryant Ranch Prepack	24f815ef-58e6-42b9-8137-adcd6c382aa6	2026-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078154 application number: ANDA078154
Levetiracetam	LEVETIRACETAM	Bryant Ranch Prepack	9e3171c9-70e2-4725-8aca-c7f83773940d	2026-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078154 application number: ANDA078154
Levetiracetam	LEVETIRACETAM	Preferred Pharmaceuticals, Inc.	e31c6830-4647-4481-b4f1-494a52c48b1b	2025-07-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078154 application number: ANDA078154 ndc (package): 68788-8254-9 ndc (product): 68788-8254 ndc11 (package): 68788825409
Levetiracetam	LEVETIRACETAM	Proficient Rx LP	6bdbc193-d86b-4bd5-8e88-4ea964d2cdde	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078154 application number: ANDA078154

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	e31c6830-4647-4481-b4f1-494a52c48b1b	4
311289	levetiracetam 500 MG Oral Tablet	SCD	e31c6830-4647-4481-b4f1-494a52c48b1b	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-8254-9	68788825409	90 TABLET, FILM COATED in 1 BOTTLE (68788-8254-9)	2022-09-02	0000-00-00	No	No	Current