FDA.reportPublic FDA data

Levetiracetam

Product NDC
50090-1333
11-digit product format
500901333
Labeler code
50090
Product ID
50090-1333_b9dfd326-74eb-49b7-bfdf-0d3364623536
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090515
Marketing category
ANDA
Marketing start
2010-10-08
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, 387003

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
76e81f18-c6b9-f226-530a-a6296d5cd5f4Product name620251106
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
087c9486-f4a9-a565-c6fb-d6fa49f4572aProduct name620230317
525a8d4d-1988-fc3f-e292-27fd384de4f0Product name820230104
32b651f8-caa7-6882-11c7-54c4ad21796bProduct name820201216
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
ce453ca5-90cf-41ed-9de4-de519f70a0f2Product name220160303
66666eb8-1fa6-4a60-bae9-e564e73b4cd5Product name120150728
eecbc0ef-ab5c-4ff9-8aaa-6ea73ee46477Product name120150410
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1333-02021-11-06C16284748780-19d75b9d0-37e7-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999
50090-1333-22021-11-06C16284748780-19d75b9d0-37e7-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999
50090-1333-02020-01-31C16284748780-19d75b9d0-37e7-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999
50090-1333-22020-01-31C16284748780-19d75b9d0-37e7-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1333-0Levetiracetam120 in 1 BOTTLETABLET, FILM COATED12036
50090-1333-1Levetiracetam60 in 1 BOTTLETABLET, FILM COATED6036
50090-1333-2Levetiracetam90 in 1 BOTTLETABLET, FILM COATED9036
50090-1333-3Levetiracetam180 in 1 BOTTLETABLET, FILM COATED18036
50090-1333-4Levetiracetam10 in 1 BOTTLETABLET, FILM COATED1036

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1333-0EA - Each50090-1333bd8c0b57-d8c5-4338-8c8a-fdbb644bddb112018-11-06
50090-1333-1EA - Each50090-133375445d5b-65e3-477d-a16c-0ed79f3ffd9212022-10-06
50090-1333-2EA - Each50090-1333dd99c069-54f3-4b60-a61e-6b13c244ae8112018-11-06
50090-1333-3EA - Each50090-1333f48ef595-4032-4f0c-ad61-fce0b2d8449e12022-10-06
50090-1333-4EA - Each50090-133358866547-a1fc-4c60-bcf5-39c067f40e0d12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1333LEVETIRACETAM (LEVETIRACETAM) TABLET, FILM COATED LEVETIRACETAM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]33Current NDC, Legacy NDC, 5 package rows20250516_b9597cd5-5745-494a-bd72-93071ed221da.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387003levETIRAcetam 1000 MG Oral TabletPSNb9597cd5-5745-494a-bd72-93071ed221da36
311289levETIRAcetam 500 MG Oral TabletPSNb9597cd5-5745-494a-bd72-93071ed221da36
387003levetiracetam 1000 MG Oral TabletSCDb9597cd5-5745-494a-bd72-93071ed221da36
311289levetiracetam 500 MG Oral TabletSCDb9597cd5-5745-494a-bd72-93071ed221da36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-1333-050090133300120 TABLET, FILM COATED in 1 BOTTLE (50090-1333-0) 2014-11-280000-00-00NoNoCurrent
50090-1333-15009013330160 TABLET, FILM COATED in 1 BOTTLE (50090-1333-1) 2022-03-100000-00-00NoNoCurrent
50090-1333-25009013330290 TABLET, FILM COATED in 1 BOTTLE (50090-1333-2) 2018-03-150000-00-00NoNoCurrent
50090-1333-350090133303180 TABLET, FILM COATED in 1 BOTTLE (50090-1333-3) 2022-03-100000-00-00NoNoCurrent
50090-1333-45009013330410 TABLET, FILM COATED in 1 BOTTLE (50090-1333-4) 2022-06-150000-00-00NoNoCurrent