LEVETIRACETAM

Product NDC: 61919-552
Requested package NDC: 61919-552-72
11-digit product format: 619190552
Labeler code: 61919
Product ID: 61919-552_e9adf8f1-95f0-5d73-e053-2a95a90a0fc2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LEVETIRACETAM
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Direct_Rx
Application: ANDA078106
Marketing category: ANDA
Marketing start: 2019-08-28
Marketing end: 0000-00-00
Substance: LEVETIRACETAM
Active strength: 250 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	61919-552	61919-552-72	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 · 9 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	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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…`

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
61919-552-30	2025-01-30	C162847	48780-1	2cef2736-875b-d83d-e063-dadaa90ab31f	LEVETIRACETAM
61919-552-72	2025-01-30	C162847	48780-1	2cef2736-875b-d83d-e063-dadaa90ab31f	LEVETIRACETAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-552-30	LEVETIRACETAM	30 in 1 BOTTLE	TABLET, FILM COATED	30		3
61919-552-72	LEVETIRACETAM	120 in 1 BOTTLE	TABLET, FILM COATED	120		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-552-60	EA - Each	61919-552	ed59cc42-a774-483a-a206-19733ec807ef	1	2019-08-06
61919-552-72	EA - Each	61919-552	4746ada4-1fbe-4c19-aef2-db0afea31f58	1	2019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-552	LEVETIRACETAM TABLET, FILM COATED [DIRECT_RX]	3	Legacy NDC, 2 package rows	20230509_912f771a-2cd0-2625-e053-2995a90a2244.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
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
311288	levETIRAcetam 250 MG Oral Tablet	PSN	912f771a-2cd0-2625-e053-2995a90a2244	3
311288	levetiracetam 250 MG Oral Tablet	SCD	912f771a-2cd0-2625-e053-2995a90a2244	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-552-72	61919055272	120 TABLET, FILM COATED in 1 BOTTLE (61919-552-72)	2019-08-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LEVETIRACETAM	Direct_Rx	2023-05-08	HUMAN PRESCRIPTION DRUG LABEL	3
LEVETIRACETAM	DIRECT RX	2019-04-17	HUMAN PRESCRIPTION DRUG LABEL	2