FDA.reportPublic FDA data

LEVETIRACETAM Extended-release

Product NDC
40051-079
11-digit product format
400510079
Labeler code
40051
Product ID
40051-079_7c902b2c-edf6-4dd0-923f-c38f2c621733
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levetiracetam
Dosage form
TABLET
Route
ORAL
Labeler
Lotus Pharmaceutical Co., Ltd. Nantou Plant
Application
ANDA202095
Marketing category
ANDA
Marketing start
2016-10-31
Marketing end
0000-00-00
Substance
LEVETIRACETAM
Active strength
750 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#

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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct40051-079DDiscontinued by firm2026-07-31
excluded packagepackage40051-07940051-079-11DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202095-001LEVETIRACETAMLEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORAL2016-06-06
A202095-002LEVETIRACETAMLEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORAL2016-06-06

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A202095-001LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORAL2016-06-06a50c72e98297…
2026-08-01 22:54:322026-06A202095-002LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORAL2016-06-06a50c72e98297…