Levetiracetam

Product NDC
35208-032
11-digit product format
352080032
Labeler code
35208
Product ID
35208-032_b0da0932-ad12-458d-b4de-5d1174cff448
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
IntelliPharmaCeutics Corp.
Application
ANDA204511
Marketing category
ANDA
Marketing start
2016-10-03
Marketing end
0000-00-00
Substance
LEVETIRACETAM
Active strength
750 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2020-12-31
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
35208-032-102025-07-29C16284748780-11030e365-30e5-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use LEVETIRACETAM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM EXTENDED-RELEASE TABLETS. LEVETIRACETAM extended-release tablets, for oral use Initial U.S. Approval: 1999
35208-032-602025-07-29C16284748780-11030e365-30e5-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use LEVETIRACETAM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM EXTENDED-RELEASE TABLETS. LEVETIRACETAM extended-release tablets, for oral use Initial U.S. Approval: 1999
35208-032-102024-01-30C16284748780-11030e365-30e5-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use LEVETIRACETAM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM EXTENDED-RELEASE TABLETS. LEVETIRACETAM extended-release tablets, for oral use Initial U.S. Approval: 1999
35208-032-602024-01-30C16284748780-11030e365-30e5-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use LEVETIRACETAM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM EXTENDED-RELEASE TABLETS. LEVETIRACETAM extended-release tablets, for oral use Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35208-032-10LevetiracetamExtended-release1000 in 1 BOTTLETABLET, EXTENDED RELEASE10005
35208-032-60LevetiracetamExtended-release60 in 1 BOTTLETABLET, EXTENDED RELEASE605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35208-032LEVETIRACETAM EXTENDED-RELEASE (LEVETIRACETAM) TABLET, EXTENDED RELEASE [INTELLIPHARMACEUTICS CORP.]5Legacy NDC, 2 package rows20171211_02727941-c5ea-4f85-beb4-2a00eec73dd0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
807832levETIRAcetam 500 MG 24HR Extended Release Oral TabletPSN02727941-c5ea-4f85-beb4-2a00eec73dd05
846378levETIRAcetam 750 MG 24HR Extended Release Oral TabletPSN02727941-c5ea-4f85-beb4-2a00eec73dd05
80783224 HR levetiracetam 500 MG Extended Release Oral TabletSCD02727941-c5ea-4f85-beb4-2a00eec73dd05
84637824 HR levetiracetam 750 MG Extended Release Oral TabletSCD02727941-c5ea-4f85-beb4-2a00eec73dd05
807832levetiracetam 500 MG 24 HR Extended Release Oral TabletSY02727941-c5ea-4f85-beb4-2a00eec73dd05
846378levetiracetam 750 MG 24 HR Extended Release Oral TabletSY02727941-c5ea-4f85-beb4-2a00eec73dd05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
35208-032-10352080032101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (35208-032-10) 2016-10-030000-00-00NoNoCurrent
35208-032-603520800326060 TABLET, EXTENDED RELEASE in 1 BOTTLE (35208-032-60) 2016-10-030000-00-00NoNoCurrent