LEVETIRACETAM

Product NDC: 61919-559
Requested package NDC: 61919-559-90
11-digit product format: 619190559
Labeler code: 61919
Product ID: 61919-559_ea4ea5a1-3101-d5dd-e053-2995a90ab48c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LEVETIRACETAM
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Direct_Rx
Application: ANDA078106
Marketing category: ANDA
Marketing start: 2019-08-29
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: 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	61919-559	61919-559-90	D	Discontinued by firm		2026-08-03

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A078106-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-02-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078106-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-02-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078106-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-02-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078106-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-02-10	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A078106-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078106-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078106-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078106-004	AB	1	`a50c72e98297…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-559-60	EA - Each	61919-559	5477d98e-20a6-4f8e-87a6-24c1f4ff7089	1	2019-05-02
61919-559-90	EA - Each	61919-559	80866bcd-2e56-4867-a8ed-2edf531a19e2	1	2019-09-05

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
61919-559-90	61919055990	90 TABLET, FILM COATED in 1 BOTTLE (61919-559-90)	2019-08-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LEVETIRACETAM	Direct_Rx	2022-10-05	HUMAN PRESCRIPTION DRUG LABEL	2
LEVETIRACETAM	DIRECT RX	2019-04-17	HUMAN PRESCRIPTION DRUG LABEL	2