Levetiracetam

Product NDC: 71335-0748
Requested package NDC: 71335-0748-1
11-digit product format: 713350748
Labeler code: 71335
Product ID: 71335-0748_f6bf21be-3860-4ebc-9be6-7e87ae311535
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
Marketing end: 0000-00-00
Substance: LEVETIRACETAM
Active strength: 500 mg/1
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71335-0748	71335-0748-1	D	Discontinued by firm		2026-08-03

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 · 13 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 164 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	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…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078106-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-02-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078106-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-02-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078106-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-02-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078106-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-02-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078106-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-02-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078106-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-02-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078106-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-02-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078106-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-02-10	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	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…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078106-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078106-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078106-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078106-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078106-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078106-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078106-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078106-004	AB	1	`d06236e962d9…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
71335-0748-1	2024-04-15	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
71335-0748-2	2024-04-15	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
71335-0748-3	2024-04-15	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
71335-0748-4	2024-04-15	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
71335-0748-5	2024-04-15	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
71335-0748-1	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
71335-0748-2	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
71335-0748-3	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
71335-0748-4	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
71335-0748-5	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-0748-1	EA - Each	71335-0748	969409a0-0596-4302-9cea-011fa0454aff	1	2019-10-07
71335-0748-2	EA - Each	71335-0748	7c80dbf6-34fa-4237-9963-ff21af0cf76f	1	2019-10-07
71335-0748-3	EA - Each	71335-0748	842b35a2-7f18-47af-b496-550c8748c789	1	2019-10-07
71335-0748-4	EA - Each	71335-0748	7f43bab8-64d4-4340-b251-2598a42c602f	1	2019-10-07

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-0748-1	71335074801	90 TABLET, FILM COATED in 1 BOTTLE (71335-0748-1)	2018-03-21	0000-00-00	No	No	Current