Levetiracetam

Product NDC
67296-1248
11-digit product format
672961248
Labeler code
67296
Product ID
67296-1248_d6102f16-888b-26db-e053-2995a90aad38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA078106
Marketing category
ANDA
Marketing start
2012-09-11
Marketing end
0000-00-00
Substance
LEVETIRACETAM
Active strength
1000 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
67296-1248-32024-01-30C16284748780-11030e365-1407-111a-e063-dadaa90a10e24f96d083-06a7-3655-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1248-3Levetiracetam30 in 1 BOTTLETABLET, FILM COATED304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1248LEVETIRACETAM TABLET, FILM COATED [REDPHARM DRUG, INC.]4Legacy NDC, 1 package rows20220121_4f96d083-06a7-3655-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387003levETIRAcetam 1000 MG Oral TabletPSN4f96d083-06a7-3655-e054-00144ff8d46c4
387003levetiracetam 1000 MG Oral TabletSCD4f96d083-06a7-3655-e054-00144ff8d46c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-1248-36729612480330 TABLET, FILM COATED in 1 BOTTLE (67296-1248-3) 2012-09-110000-00-00NoNoCurrent