Levetiracetam

Product NDC: 50090-3889
11-digit product format: 500903889
Labeler code: 50090
Product ID: 50090-3889_a6669ca2-a3aa-4352-b369-11bd2371f5fb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levetiracetam
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA078993
Marketing category: ANDA
Marketing start: 2009-01-15
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: 2022-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50090-3889		D	Discontinued by firm	2026-08-07
excluded package	package	50090-3889	50090-3889-0	D	Discontinued by firm	2026-08-07
excluded package	package	50090-3889	50090-3889-2	D	Discontinued by firm	2026-08-07

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 · 33 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-3889-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-3889-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-3889-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-3889-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-3889-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-3889-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-3889-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-3889-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-3889-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-3889-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-3889-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-3889-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-3889-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-3889-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-3889-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-3889-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-3889-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-3889-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50090-3889-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50090-3889-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-3889-2	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-3889-0	`367a005e9d99…`	`383a685ebd0f…`

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
A078993-001	LEVETIRACETAM	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15
A078993-002	LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15
A078993-003	LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15
A078993-004	LEVETIRACETAM	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078993-001	AB
A078993-002	AB
A078993-003	AB
A078993-004	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	A078993-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078993-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078993-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078993-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078993-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078993-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078993-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078993-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078993-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078993-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078993-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078993-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078993-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078993-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078993-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078993-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078993-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078993-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078993-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078993-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078993-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078993-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078993-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078993-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078993-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078993-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078993-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078993-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078993-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078993-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078993-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078993-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078993-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078993-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078993-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078993-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078993-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078993-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078993-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078993-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`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	A078993-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078993-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078993-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078993-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078993-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078993-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078993-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078993-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078993-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078993-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078993-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078993-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078993-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078993-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078993-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078993-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078993-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078993-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078993-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078993-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078993-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078993-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078993-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078993-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078993-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078993-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078993-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078993-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078993-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078993-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078993-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078993-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078993-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078993-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078993-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078993-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078993-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078993-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078993-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078993-004	AB	1	`d06236e962d9…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50090-3889-0	2023-02-06	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
50090-3889-2	2023-02-06	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
50090-3889-0	2023-01-30	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
50090-3889-2	2023-01-30	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

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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levetiracetam	LEVETIRACETAM	Unit Dose Solutions, Inc.	551626eb-3282-e439-e063-6294a90a8314	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078993 application number: ANDA078993
Levetiracetam	LEVETIRACETAM	Coupler LLC	53843871-23e3-974e-e063-6394a90a8042	2026-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078993 application number: ANDA078993
Levetiracetam	LEVETIRACETAM	Coupler LLC	51b66893-f7d6-8f9d-e063-6294a90a8e9b	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078993 application number: ANDA078993
Levetiracetam	LEVETIRACETAM	Coupler LLC	5037a86a-21f2-d793-e063-6394a90a2cb5	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078993 application number: ANDA078993
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	6e31e766-6504-4f20-8831-1953363cace0	2025-11-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078993 application number: ANDA078993
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	01aef7f7-6092-4e39-8451-dc02d8db9254	2025-11-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078993 application number: ANDA078993
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	58ed7049-44c6-4f97-9174-c0e1504586a6	2025-11-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078993 application number: ANDA078993
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	5eb7bea5-c95f-4a38-a5bb-c20d1549c797	2025-11-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078993 application number: ANDA078993
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	bc12f0b0-e05c-48e4-ad08-0ff14a818a64	2025-11-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078993 application number: ANDA078993
Levetiracetam	LEVETIRACETAM	Major Pharmaceuticals	c4b27429-50a3-467c-a5ff-7e49a01a1088	2025-09-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078993 application number: ANDA078993
Levetiracetam	LEVETIRACETAM	Cardinal Health 107, LLC	0348fec4-d919-4307-ac90-35360819bc00	2025-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078993 application number: ANDA078993
Levetiracetam	LEVETIRACETAM	BluePoint Laboratories	8b74b8bc-d95c-4471-8f74-c3117243bf89	2024-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078993 application number: ANDA078993
Levetiracetam	LEVETIRACETAM	American Health Packaging	fc8bf57e-8aa2-4d3c-856d-b19de65e3ba0	2024-11-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078993 application number: ANDA078993
Levetiracetam	LEVETIRACETAM	American Health Packaging	031a32e1-675a-4efe-a66b-40beb4fe5101	2024-06-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078993 application number: ANDA078993
Levetiracetam	LEVETIRACETAM	Aurobindo Pharma Limited	2471ee03-d747-4113-86d0-1aa93c8f3eba	2024-04-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078993 application number: ANDA078993

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
50090-3889-0	50090388900	120 TABLET, FILM COATED in 1 BOTTLE (50090-3889-0)	2018-11-30	0000-00-00	No	No	Current
50090-3889-2	50090388902	90 TABLET, FILM COATED in 1 BOTTLE (50090-3889-2)	2018-11-30	0000-00-00	No	No	Current