FDA.reportPublic FDA data

Levetiracetam

Product NDC
63629-4675
11-digit product format
636294675
Labeler code
63629
Product ID
63629-4675_93506504-64ac-4aeb-9fa8-50592a296d02
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
250 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
LEVETIRACETAM250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii44YRR34555
Rxcui311288

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
63629-4675-12022-02-16C16284748780-19855d018-ec1e-cd31-e053-dbdaa90ab51aThese 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
63629-4675-22022-02-16C16284748780-19855d018-ec1e-cd31-e053-dbdaa90ab51aThese 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
63629-4675-32022-02-16C16284748780-19855d018-ec1e-cd31-e053-dbdaa90ab51aThese 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
63629-4675-12019-11-27C16284748780-19855d018-ec1e-cd31-e053-dbdaa90ab51aThese 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
63629-4675-22019-11-27C16284748780-19855d018-ec1e-cd31-e053-dbdaa90ab51aThese 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
63629-4675-32019-11-27C16284748780-19855d018-ec1e-cd31-e053-dbdaa90ab51aThese 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
63629-4675-1Levetiracetam60 in 1 BOTTLETABLET, FILM COATED601007
63629-4675-2Levetiracetam30 in 1 BOTTLETABLET, FILM COATED301007
63629-4675-3Levetiracetam120 in 1 BOTTLETABLET, FILM COATED1201007
63629-4675-4Levetiracetam90 in 1 BOTTLETABLET, FILM COATED901007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-4675-1EA - Each63629-46758575b35a-d027-41fe-b931-5c970d5d2db612015-10-02
63629-4675-2EA - Each63629-467576f6c84f-1704-4e60-a230-549161e85e1c12015-10-02
63629-4675-3EA - Each63629-46757eb584e0-6542-4496-adb2-825414bd48f512015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POVIDONESINACTIVE INGREDIENTFZ989GH94ELEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
TALCINACTIVE INGREDIENT7SEV7J4R1ULEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]1000

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-4675LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]1006Current NDC, Legacy NDC, 4 package rows20240417_9e3171c9-70e2-4725-8aca-c7f83773940d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311288levETIRAcetam 250 MG Oral TabletPSN9e3171c9-70e2-4725-8aca-c7f83773940d1007
311288levetiracetam 250 MG Oral TabletSCD9e3171c9-70e2-4725-8aca-c7f83773940d1007

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-4675-16362946750160 TABLET, FILM COATED in 1 BOTTLE (63629-4675-1) 2013-04-170000-00-00NoNoCurrent
63629-4675-26362946750230 TABLET, FILM COATED in 1 BOTTLE (63629-4675-2) 2012-09-060000-00-00NoNoCurrent
63629-4675-363629467503120 TABLET, FILM COATED in 1 BOTTLE (63629-4675-3) 2013-04-110000-00-00NoNoCurrent
63629-4675-46362946750490 TABLET, FILM COATED in 1 BOTTLE (63629-4675-4) 2024-04-020000-00-00NoNoCurrent