Levetiracetam

Product NDC: 53808-0377
11-digit product format: 538080377
Labeler code: 53808
Product ID: 53808-0377_80210249-70fb-4d75-be2b-8c490f5d26fe
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levetiracetam
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: State of Florida DOH Central Pharmacy
Application: ANDA078234
Marketing category: ANDA
Marketing start: 2009-07-01
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: E
Listing certified through: 2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53808-0377		I	Inactivated by FDA		2026-08-03
excluded package	package	53808-0377	53808-0377-1	I	Inactivated by FDA		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 · 44 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	53808-0377-1	`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	53808-0377-1	`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	53808-0377-1	`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	53808-0377-1	`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	53808-0377-1	`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	53808-0377-1	`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	53808-0377-1	`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	53808-0377-1	`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	53808-0377-1	`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	53808-0377-1	`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	53808-0377-1	`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	53808-0377-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53808-0377-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53808-0377-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53808-0377-1	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53808-0377-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53808-0377-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53808-0377-1	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53808-0377-1	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53808-0377-1	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53808-0377-1	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	53808-0377-1	`110d247fa046…`	`a55b01930146…`

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	Approval date
A078234-001	LEVETIRACETAM	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15
A078234-002	LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15
A078234-003	LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078234-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078234-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078234-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078234-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078234-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078234-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078234-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078234-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078234-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078234-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078234-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078234-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078234-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078234-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078234-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078234-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078234-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078234-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078234-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078234-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078234-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078234-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078234-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078234-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078234-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078234-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078234-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078234-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078234-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078234-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078234-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078234-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078234-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078234-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078234-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078234-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078234-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078234-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078234-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078234-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078234-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078234-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078234-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078234-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078234-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078234-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078234-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078234-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078234-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078234-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078234-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078234-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078234-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078234-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078234-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078234-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078234-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078234-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078234-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078234-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078234-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078234-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078234-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078234-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078234-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078234-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078234-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078234-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078234-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078234-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078234-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078234-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078234-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078234-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078234-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078234-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078234-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078234-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078234-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078234-001	AB	1	`6a51e52b5d6a…`

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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53808-0377-1	2019-10-21	C162847	48780-1	956f9ecf-de3c-621f-e053-dbdaa90a74ad	Levetiracetam Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53808-0377-1	Levetiracetam	30 in 1 BLISTER PACK	TABLET, FILM COATED	30		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVETIRACETAM	ACTIVE INGREDIENT	44YRR34555	LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
LEVETIRACETAM	ACTIVE MOIETY	44YRR34555	LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POLYETHYLENE GLYCOL 4000	INACTIVE INGREDIENT	4R4HFI6D95	LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53808-0377	LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1	Legacy NDC, 1 package rows	20100611_4fe5abcd-4d9c-486c-9ac5-32c27845eae8.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levetiracetam	LEVETIRACETAM	Exelan Pharmaceuticals, Inc.	28c0e61e-1af9-410a-9fa9-b71bf99a776b	2018-11-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078234 application number: ANDA078234

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	4fe5abcd-4d9c-486c-9ac5-32c27845eae8	1
311289	levetiracetam 500 MG Oral Tablet	SCD	4fe5abcd-4d9c-486c-9ac5-32c27845eae8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53808-0377-1	53808037701	30 in 1 BLISTER PACK	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levetiracetam Tablets	State of Florida DOH Central Pharmacy	2010-05-26	HUMAN PRESCRIPTION DRUG LABEL	1