FDA.reportPublic FDA data

Levetiracetam

Product NDC
63629-4137
11-digit product format
636294137
Labeler code
63629
Product ID
63629-4137_505a2d97-ea8d-4e3a-9af7-95df7f59d89b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078154
Marketing category
ANDA
Marketing start
2009-01-15
Substance
LEVETIRACETAM
Active strength
500 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Levetiracetam
Listing expiration
2027-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-4137-12020-07-21C16284748780-19d75b9d1-0f00-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use LEVETIRACETAM TABLETS USP safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS USP. LEVETIRACETAM tablets USP, for oral use Initial U.S. Approval: 1999
63629-4137-22020-07-21C16284748780-19d75b9d1-0f00-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use LEVETIRACETAM TABLETS USP safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS USP. LEVETIRACETAM tablets USP, for oral use Initial U.S. Approval: 1999
63629-4137-32020-07-21C16284748780-19d75b9d1-0f00-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use LEVETIRACETAM TABLETS USP safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS USP. LEVETIRACETAM tablets USP, for oral use Initial U.S. Approval: 1999
63629-4137-42020-07-21C16284748780-19d75b9d1-0f00-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use LEVETIRACETAM TABLETS USP safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS USP. LEVETIRACETAM tablets USP, for oral use Initial U.S. Approval: 1999
63629-4137-52020-07-21C16284748780-19d75b9d1-0f00-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use LEVETIRACETAM TABLETS USP safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS USP. LEVETIRACETAM tablets USP, for oral use Initial U.S. Approval: 1999
63629-4137-12020-01-31C16284748780-19d75b9d1-0f00-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use LEVETIRACETAM TABLETS USP safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS USP. LEVETIRACETAM tablets USP, for oral use Initial U.S. Approval: 1999
63629-4137-22020-01-31C16284748780-19d75b9d1-0f00-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use LEVETIRACETAM TABLETS USP safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS USP. LEVETIRACETAM tablets USP, for oral use Initial U.S. Approval: 1999
63629-4137-32020-01-31C16284748780-19d75b9d1-0f00-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use LEVETIRACETAM TABLETS USP safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS USP. LEVETIRACETAM tablets USP, for oral use Initial U.S. Approval: 1999
63629-4137-42020-01-31C16284748780-19d75b9d1-0f00-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use LEVETIRACETAM TABLETS USP safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS USP. LEVETIRACETAM tablets USP, for oral use Initial U.S. Approval: 1999
63629-4137-52020-01-31C16284748780-19d75b9d1-0f00-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use LEVETIRACETAM TABLETS USP safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS USP. LEVETIRACETAM tablets USP, for oral use Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-4137-1Levetiracetam90 in 1 BOTTLETABLET, FILM COATED9018
63629-4137-2Levetiracetam60 in 1 BOTTLETABLET, FILM COATED6018
63629-4137-3Levetiracetam30 in 1 BOTTLETABLET, FILM COATED3018
63629-4137-4Levetiracetam120 in 1 BOTTLETABLET, FILM COATED12018
63629-4137-5Levetiracetam28 in 1 BOTTLETABLET, FILM COATED2818
63629-4137-6Levetiracetam100 in 1 BOTTLETABLET, FILM COATED10018
63629-4137-7Levetiracetam21 in 1 BOTTLETABLET, FILM COATED2118
63629-4137-8Levetiracetam180 in 1 BOTTLETABLET, FILM COATED18018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-4137-1EA - Each63629-41373a3ef8b3-2bb0-45be-b3f7-06f006fb9c6412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]6
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]6
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]6
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]6
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]6
POVIDONESINACTIVE INGREDIENTFZ989GH94ELEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]6
TALCINACTIVE INGREDIENT7SEV7J4R1ULEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-4137LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]17Current NDC, Legacy NDC, 8 package rows20240607_24f815ef-58e6-42b9-8137-adcd6c382aa6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311289levETIRAcetam 500 MG Oral TabletPSN24f815ef-58e6-42b9-8137-adcd6c382aa618
311289levetiracetam 500 MG Oral TabletSCD24f815ef-58e6-42b9-8137-adcd6c382aa618

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-4137-16362941370190 TABLET, FILM COATED in 1 BOTTLE (63629-4137-1) 2010-02-180000-00-00NoNoCurrent
63629-4137-26362941370260 TABLET, FILM COATED in 1 BOTTLE (63629-4137-2) 2011-09-060000-00-00NoNoCurrent
63629-4137-36362941370330 TABLET, FILM COATED in 1 BOTTLE (63629-4137-3) 2012-02-240000-00-00NoNoCurrent
63629-4137-463629413704120 TABLET, FILM COATED in 1 BOTTLE (63629-4137-4) 2013-04-190000-00-00NoNoCurrent
63629-4137-56362941370528 TABLET, FILM COATED in 1 BOTTLE (63629-4137-5) 2023-03-060000-00-00NoNoCurrent
63629-4137-663629413706100 TABLET, FILM COATED in 1 BOTTLE (63629-4137-6) 2023-03-06NoNoHistorical
63629-4137-76362941370721 TABLET, FILM COATED in 1 BOTTLE (63629-4137-7) 2024-04-02NoNoHistorical
63629-4137-863629413708180 TABLET, FILM COATED in 1 BOTTLE (63629-4137-8) 2026-04-02NoNoHistorical