FDA.reportPublic FDA data

Levetiracetam

Product NDC
80425-0565
11-digit product format
804250565
Labeler code
80425
Product ID
80425-0565_45a04d05-6f76-0d6b-e063-6294a90a935d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA091491
Marketing category
ANDA
Marketing start
2025-12-10
Substance
LEVETIRACETAM
Active strength
500 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Levetiracetam
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVETIRACETAM500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii44YRR34555
Rxcui311289

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
76e81f18-c6b9-f226-530a-a6296d5cd5f4Product name620251106
087c9486-f4a9-a565-c6fb-d6fa49f4572aProduct name620230317
525a8d4d-1988-fc3f-e292-27fd384de4f0Product name820230104
32b651f8-caa7-6882-11c7-54c4ad21796bProduct name820201216
ce453ca5-90cf-41ed-9de4-de519f70a0f2Product name220160303
66666eb8-1fa6-4a60-bae9-e564e73b4cd5Product name120150728
eecbc0ef-ab5c-4ff9-8aaa-6ea73ee46477Product name120150410

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0565-1Levetiracetam120 in 1 BOTTLETABLET1201
80425-0565-2Levetiracetam30 in 1 BOTTLETABLET301
80425-0565-3Levetiracetam60 in 1 BOTTLETABLET601
80425-0565-4Levetiracetam90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0565-1EA - Each80425-0565fcd400cd-9dc7-4e0d-a3cf-76c55e3ef84712026-01-08
80425-0565-2EA - Each80425-0565bf0a0a19-9d47-49be-bc73-a81855d8749312026-01-08
80425-0565-3EA - Each80425-05652db59d12-235f-4df5-9ee5-967ddbd0c95912026-01-08
80425-0565-4EA - Each80425-05651813d63d-f998-4edd-9b52-b46ca45b59f512026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311289levETIRAcetam 500 MG Oral TabletPSN45a03a43-04db-9138-e063-6394a90a12fa1
311289levetiracetam 500 MG Oral TabletSCD45a03a43-04db-9138-e063-6394a90a12fa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0565-180425056501120 TABLET in 1 BOTTLE (80425-0565-1) 120 tablet2025-12-10NoNoHistorical
80425-0565-28042505650230 TABLET in 1 BOTTLE (80425-0565-2) 30 tablet2025-12-10NoNoHistorical
80425-0565-38042505650360 TABLET in 1 BOTTLE (80425-0565-3) 60 tablet2025-12-10NoNoHistorical
80425-0565-48042505650490 TABLET in 1 BOTTLE (80425-0565-4) 90 tablet2025-12-10NoNoHistorical