LEVETIRACETAM

Product NDC
61919-552
11-digit product format
619190552
Labeler code
61919
Product ID
61919-552_e9adf8f1-95f0-5d73-e053-2a95a90a0fc2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVETIRACETAM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA078106
Marketing category
ANDA
Marketing start
2019-08-28
Marketing end
0000-00-00
Substance
LEVETIRACETAM
Active strength
250 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
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
61919-552-302025-01-30C16284748780-12cef2736-875b-d83d-e063-dadaa90ab31fLEVETIRACETAM
61919-552-722025-01-30C16284748780-12cef2736-875b-d83d-e063-dadaa90ab31fLEVETIRACETAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-552-30LEVETIRACETAM30 in 1 BOTTLETABLET, FILM COATED303
61919-552-72LEVETIRACETAM120 in 1 BOTTLETABLET, FILM COATED1203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-552-60EA - Each61919-552ed59cc42-a774-483a-a206-19733ec807ef12019-08-06
61919-552-72EA - Each61919-5524746ada4-1fbe-4c19-aef2-db0afea31f5812019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-552LEVETIRACETAM TABLET, FILM COATED [DIRECT_RX]3Legacy NDC, 2 package rows20230509_912f771a-2cd0-2625-e053-2995a90a2244.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311288levETIRAcetam 250 MG Oral TabletPSN912f771a-2cd0-2625-e053-2995a90a22443
311288levetiracetam 250 MG Oral TabletSCD912f771a-2cd0-2625-e053-2995a90a22443

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-552-306191905523030 TABLET, FILM COATED in 1 BOTTLE (61919-552-30) 2019-08-280000-00-00NoNoCurrent
61919-552-606191905526060 TABLET, FILM COATED in 1 BOTTLE (61919-552-60) 2018-07-300000-00-00NoNoCurrent
61919-552-7261919055272120 TABLET, FILM COATED in 1 BOTTLE (61919-552-72) 2019-08-280000-00-00NoNoCurrent