Levetiracetam

Product NDC: 70518-0126
11-digit product format: 705180126
Labeler code: 70518
Product ID: 70518-0126_4a1712df-f706-03cd-e054-00144ff8d46c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levetiracetam
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA077319
Marketing category: ANDA
Marketing start: 2017-01-16
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: 2018-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	70518-0126		D	Discontinued by firm		2026-07-31
excluded package	package	70518-0126	70518-0126-0	D	Discontinued by firm		2026-07-31

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
A077319-001	LEVETIRACETAM	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-03-20
A077319-002	LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-03-20
A077319-003	LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-03-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A077319-001	AB
A077319-002	AB
A077319-003	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.

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	A077319-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-03-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077319-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-03-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077319-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-03-20	`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	A077319-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077319-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077319-003	AB	1	`a50c72e98297…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-0126-0	2020-03-29	C162847	48780-1	9d75b9d0-d93c-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use levetiracetam safely and effectively. See full prescribing information for levetiracetam. LEVETIRACETAM tablets, USP, for oral use Initial U.S. Approval: 1999
70518-0126-0	2020-01-31	C162847	48780-1	9d75b9d0-d93c-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use levetiracetam safely and effectively. See full prescribing information for levetiracetam. LEVETIRACETAM tablets, USP, for oral use Initial U.S. Approval: 1999