LEVETIRACETAM

Product NDC: 61919-552
Requested package NDC: 61919-552-30
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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	61919-552-30	I	Inactivated by FDA		2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 3 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-552	61919-552-30	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-552	61919-552-30	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-552	61919-552-30	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`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…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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

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
61919-552-30	61919055230	30 TABLET, FILM COATED in 1 BOTTLE (61919-552-30)	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