FDA.reportPublic FDA data

Levetiracetam

Product NDC
80425-0566
11-digit product format
804250566
Labeler code
80425
Product ID
80425-0566_45a04c5b-7c31-19bf-e063-6294a90aad27
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
80425-0566-1Levetiracetam120 in 1 BOTTLETABLET1201
80425-0566-2Levetiracetam30 in 1 BOTTLETABLET301
80425-0566-3Levetiracetam60 in 1 BOTTLETABLET601
80425-0566-4Levetiracetam90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0566-1EA - Each80425-05664ca41aa7-2654-4b03-90cf-f3a3fe3f46d212026-01-08
80425-0566-2EA - Each80425-0566edcb2463-2ad3-43e4-9d06-819e50300f3e12026-01-08
80425-0566-3EA - Each80425-05669fcb051a-cb95-4d54-9fcc-3ded20b62add12026-01-08
80425-0566-4EA - Each80425-05662174dc95-f629-4e7f-951b-7055705acde912026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311289levETIRAcetam 500 MG Oral TabletPSN45a07f44-078d-0513-e063-6394a90a16291
311289levetiracetam 500 MG Oral TabletSCD45a07f44-078d-0513-e063-6394a90a16291

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0566-180425056601120 TABLET in 1 BOTTLE (80425-0566-1) 120 tablet2025-12-10NoNoHistorical
80425-0566-28042505660230 TABLET in 1 BOTTLE (80425-0566-2) 30 tablet2025-12-10NoNoHistorical
80425-0566-38042505660360 TABLET in 1 BOTTLE (80425-0566-3) 60 tablet2025-12-10NoNoHistorical
80425-0566-48042505660490 TABLET in 1 BOTTLE (80425-0566-4) 90 tablet2025-12-10NoNoHistorical