FDA.reportPublic FDA data

Levetiracetam

Product NDC
67046-420
11-digit product format
670460420
Labeler code
67046
Product ID
67046-420_59cd5863-1c39-df08-e053-2991aa0ab6f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA078154
Marketing category
ANDA
Marketing start
2017-09-22
Marketing end
0000-00-00
Substance
LEVETIRACETAM
Active strength
500 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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
67046-420-072020-01-31C16284748780-19d75b9d0-3457-f424-e053-dadaa90a57ce420 Levetiracetam 500 mg These 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
67046-420-142020-01-31C16284748780-19d75b9d0-3457-f424-e053-dadaa90a57ce420 Levetiracetam 500 mg These 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
67046-420-152020-01-31C16284748780-19d75b9d0-3457-f424-e053-dadaa90a57ce420 Levetiracetam 500 mg These 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
67046-420-202020-01-31C16284748780-19d75b9d0-3457-f424-e053-dadaa90a57ce420 Levetiracetam 500 mg These 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
67046-420-212020-01-31C16284748780-19d75b9d0-3457-f424-e053-dadaa90a57ce420 Levetiracetam 500 mg These 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
67046-420-282020-01-31C16284748780-19d75b9d0-3457-f424-e053-dadaa90a57ce420 Levetiracetam 500 mg These 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
67046-420-302020-01-31C16284748780-19d75b9d0-3457-f424-e053-dadaa90a57ce420 Levetiracetam 500 mg These 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
67046-420-602020-01-31C16284748780-19d75b9d0-3457-f424-e053-dadaa90a57ce420 Levetiracetam 500 mg These 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
67046-420-07Levetiracetam7 in 1 BLISTER PACKTABLET, FILM COATED71
67046-420-14Levetiracetam14 in 1 BLISTER PACKTABLET, FILM COATED141
67046-420-15Levetiracetam15 in 1 BLISTER PACKTABLET, FILM COATED151
67046-420-20Levetiracetam20 in 1 BLISTER PACKTABLET, FILM COATED201
67046-420-21Levetiracetam21 in 1 BLISTER PACKTABLET, FILM COATED211
67046-420-28Levetiracetam28 in 1 BLISTER PACKTABLET, FILM COATED281
67046-420-30Levetiracetam30 in 1 BLISTER PACKTABLET, FILM COATED301
67046-420-60Levetiracetam60 in 1 BLISTER PACKTABLET, FILM COATED601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-420LEVETIRACETAM TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 8 package rows20170923_59cd5863-1c38-df08-e053-2991aa0ab6f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311289levETIRAcetam 500 MG Oral TabletPSN59cd5863-1c38-df08-e053-2991aa0ab6f71
311289levetiracetam 500 MG Oral TabletSCD59cd5863-1c38-df08-e053-2991aa0ab6f71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67046-420-07670460420077 in 1 BLISTER PACKHistorical
67046-420-146704604201414 in 1 BLISTER PACKHistorical
67046-420-156704604201515 in 1 BLISTER PACKHistorical
67046-420-206704604202020 in 1 BLISTER PACKHistorical
67046-420-216704604202121 in 1 BLISTER PACKHistorical
67046-420-286704604202828 in 1 BLISTER PACKHistorical
67046-420-306704604203030 in 1 BLISTER PACKHistorical
67046-420-606704604206060 in 1 BLISTER PACKHistorical