Levetiracetam

Product NDC: 0378-5613
11-digit product format: 003785613
Labeler code: 0378
Product ID: 0378-5613_5c6f87fe-aabf-4349-9f1b-a280256dce5e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: levetiracetam
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA076919
Marketing category: ANDA
Marketing start: 2008-11-04
Marketing end: 2023-03-31
Substance: LEVETIRACETAM
Active strength: 250 mg/1
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 0000-00-00
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	0378-5613		D	Discontinued by firm	2026-08-11
excluded package	package	0378-5613	0378-5613-05	D	Discontinued by firm	2026-08-11
excluded package	package	0378-5613	0378-5613-78	D	Discontinued by firm	2026-08-11

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 · 36 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	0378-5613-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0378-5613-78	`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	0378-5613-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0378-5613-78	`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	0378-5613-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0378-5613-78	`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	0378-5613-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0378-5613-78	`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	0378-5613-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0378-5613-78	`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	0378-5613-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0378-5613-78	`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	0378-5613-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0378-5613-78	`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	0378-5613-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0378-5613-78	`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	0378-5613-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0378-5613-78	`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	0378-5613-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0378-5613-78	`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	0378-5613-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0378-5613-78	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0378-5613-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0378-5613-78	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A076919-001	LEVETIRACETAM	LEVETIRACETAM	250MG	TABLET / ORAL		2008-11-04
A076919-002	LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2008-11-04
A076919-003	LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2008-11-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A076919-002	AB
A076919-003	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	A076919-001	LEVETIRACETAM	250MG	TABLET / ORAL		2008-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076919-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2008-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076919-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2008-11-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076919-001	LEVETIRACETAM	250MG	TABLET / ORAL		2008-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076919-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2008-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076919-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2008-11-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076919-001	LEVETIRACETAM	250MG	TABLET / ORAL		2008-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076919-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2008-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076919-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2008-11-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076919-001	LEVETIRACETAM	250MG	TABLET / ORAL		2008-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076919-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2008-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076919-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2008-11-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076919-001	LEVETIRACETAM	250MG	TABLET / ORAL		2008-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076919-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2008-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076919-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2008-11-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076919-001	LEVETIRACETAM	250MG	TABLET / ORAL		2008-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076919-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2008-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076919-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2008-11-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076919-001	LEVETIRACETAM	250MG	TABLET / ORAL		2008-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076919-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2008-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076919-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2008-11-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076919-001	LEVETIRACETAM	250MG	TABLET / ORAL		2008-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076919-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2008-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076919-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2008-11-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076919-001	LEVETIRACETAM	250MG	TABLET / ORAL		2008-11-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076919-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2008-11-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076919-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2008-11-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076919-001	LEVETIRACETAM	250MG	TABLET / ORAL		2008-11-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076919-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2008-11-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076919-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2008-11-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076919-001	LEVETIRACETAM	250MG	TABLET / ORAL		2008-11-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076919-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2008-11-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076919-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2008-11-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076919-001	LEVETIRACETAM	250MG	TABLET / ORAL		2008-11-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076919-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2008-11-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076919-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2008-11-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076919-001	LEVETIRACETAM	250MG	TABLET / ORAL		2008-11-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076919-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2008-11-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076919-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2008-11-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076919-001	LEVETIRACETAM	250MG	TABLET / ORAL		2008-11-04	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 101 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	A076919-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076919-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076919-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076919-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076919-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076919-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076919-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076919-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076919-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076919-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076919-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076919-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076919-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076919-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076919-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076919-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076919-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076919-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076919-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076919-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076919-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076919-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076919-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076919-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076919-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076919-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076919-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076919-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076919-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076919-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076919-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076919-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076919-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076919-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076919-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076919-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076919-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076919-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076919-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076919-003	AB	1	`74a2ff9319b5…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-5613-05	EA - Each	0378-5613	6c6e3deb-30b5-4b4b-b8b6-af9f7d1f3706	1	2012-07-24
0378-5613-07	EA - Each	0378-5613	b86d41c7-b3b9-403f-95ce-cc33448d8f31	1	2013-02-13
0378-5613-12	EA - Each	0378-5613	0c3a52b6-130a-425d-a6ab-b1c19f16d601	1	2013-02-13
0378-5613-78	EA - Each	0378-5613	931f58e4-c6b6-4973-83e5-51bb02415e7f	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVETIRACETAM	ACTIVE INGREDIENT	44YRR34555	LEVETIRACETAM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
LEVETIRACETAM	ACTIVE MOIETY	44YRR34555	LEVETIRACETAM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVETIRACETAM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	LEVETIRACETAM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LEVETIRACETAM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVETIRACETAM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	LEVETIRACETAM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	LEVETIRACETAM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	LEVETIRACETAM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEVETIRACETAM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	LEVETIRACETAM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LEVETIRACETAM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	LEVETIRACETAM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5

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	Cardinal Health 107, LLC	e1b14939-7262-40dc-a334-2b3b72c88d47	2026-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076919 application number: ANDA076919
Levetiracetam	LEVETIRACETAM	Safecor Health LLC	e72a7410-13fd-40e4-befb-052d0455e038	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076919 application number: ANDA076919
Levetiracetam	LEVETIRACETAM	Mylan Institutional Inc.	08e1bfea-7f3f-42d9-823d-f75080e664ff	2025-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076919 application number: ANDA076919
Levetiracetam	LEVETIRACETAM	Mylan Pharmaceuticals Inc.	0a987d59-560f-4650-96ec-31aec81953b5	2025-04-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076919 application number: ANDA076919

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
0378-5613-05	00378561305	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5613-05)	2008-11-04	2023-03-31	No	No	Current
0378-5613-78	00378561378	120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5613-78)	2008-11-04	2023-03-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levetiracetam	REMEDYREPACK INC.	2020-04-06	HUMAN PRESCRIPTION DRUG LABEL	5
Levetiracetam	NCS HealthCare of KY, Inc dba Vangard Labs	2015-01-28	HUMAN PRESCRIPTION DRUG LABEL	5