Levetiracetam

Product NDC: 63629-7516
Requested package NDC: 63629-7516-2
11-digit product format: 636297516
Labeler code: 63629
Product ID: 63629-7516_d310428a-bf9e-4838-b409-3282dde4890b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levetiracetam
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA078106
Marketing category: ANDA
Marketing start: 2012-09-11
Substance: LEVETIRACETAM
Active strength: 1000 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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	63629-7516	63629-7516-2	I	Inactivated by FDA		excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	63629-7516	63629-7516-2	I	Inactivated by FDA		excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`

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
A078106-001	LEVETIRACETAM	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-02-10
A078106-002	LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-02-10
A078106-003	LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-02-10
A078106-004	LEVETIRACETAM	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-02-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078106-001	AB
A078106-002	AB
A078106-003	AB
A078106-004	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	A078106-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078106-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078106-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078106-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-02-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078106-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078106-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078106-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078106-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-02-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078106-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078106-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078106-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078106-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-02-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078106-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078106-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078106-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078106-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-02-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078106-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-02-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078106-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-02-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078106-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-02-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078106-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-02-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078106-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078106-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078106-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078106-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-02-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078106-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-02-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078106-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-02-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078106-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-02-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078106-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-02-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078106-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-02-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078106-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-02-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078106-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-02-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078106-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-02-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078106-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-02-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078106-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-02-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078106-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-02-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078106-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-02-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078106-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-02-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078106-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-02-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078106-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-02-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078106-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-02-10	`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	A078106-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078106-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078106-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078106-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078106-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078106-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078106-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078106-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078106-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078106-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078106-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078106-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078106-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078106-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078106-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078106-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078106-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078106-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078106-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078106-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078106-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078106-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078106-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078106-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078106-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078106-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078106-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078106-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078106-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078106-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078106-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078106-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078106-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078106-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078106-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078106-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078106-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078106-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078106-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078106-004	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	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
ed8e88d0-993e-4683-bdcf-31578130d3df	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-7516-1	2024-05-16	These highlights do not include all the information needed to use LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999
63629-7516-2	2024-05-16	These highlights do not include all the information needed to use LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999
63629-7516-3	2024-05-16	These highlights do not include all the information needed to use LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999
63629-7516-4	2024-05-16	These highlights do not include all the information needed to use LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999
63629-7516-1	2024-01-30	These highlights do not include all the information needed to use LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999
63629-7516-2	2024-01-30	These highlights do not include all the information needed to use LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999
63629-7516-3	2024-01-30	These highlights do not include all the information needed to use LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999
63629-7516-4	2024-01-30	These highlights do not include all the information needed to use LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63629-7516-1	Levetiracetam	30 in 1 BOTTLE	TABLET, FILM COATED	30	5
63629-7516-2	Levetiracetam	90 in 1 BOTTLE	TABLET, FILM COATED	90	5
63629-7516-3	Levetiracetam	58 in 1 BOTTLE	TABLET, FILM COATED	58	5
63629-7516-4	Levetiracetam	60 in 1 BOTTLE	TABLET, FILM COATED	60	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-7516	LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]	5	Current NDC, Legacy NDC, 4 package rows	20240518_ed8e88d0-993e-4683-bdcf-31578130d3df.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levetiracetam	LEVETIRACETAM	Bryant Ranch Prepack	ed8e88d0-993e-4683-bdcf-31578130d3df	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078106 application number: ANDA078106 ndc (package): 63629-7516-2 ndc (product): 63629-7516 ndc11 (package): 63629751602
Levetiracetam	LEVETIRACETAM	Solco Healthcare US, LLC	57f09129-7151-4a75-9d73-9dd32f74ba43	2024-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078106 application number: ANDA078106
Levetiracetam	LEVETIRACETAM	Solco Healthcare US, LLC	dd713e60-478c-43cd-b680-ff594a0b3864	2024-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078106 application number: ANDA078106
Levetiracetam	LEVETIRACETAM	Prinston Pharmaceutical Inc.	d818ef84-9b3e-434b-92d9-910cfa8af7da	2020-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078106 application number: ANDA078106

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	ed8e88d0-993e-4683-bdcf-31578130d3df	5
387003	levetiracetam 1000 MG Oral Tablet	SCD	ed8e88d0-993e-4683-bdcf-31578130d3df	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-7516-2	63629751602	90 TABLET, FILM COATED in 1 BOTTLE (63629-7516-2)	2018-01-23	0000-00-00	No	No	Current