Levetiracetam

Product NDC
67296-1636
11-digit product format
672961636
Labeler code
67296
Product ID
67296-1636_b8d08b7b-cbfe-9efd-e053-2995a90a89e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA078154
Marketing category
ANDA
Marketing start
2019-01-01
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
2022-12-31
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
67296-1636-22023-01-30C16284748780-1f386c64a-0774-0266-e053-dadaa90a7c1aLevetiracetam 500mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1636-2Levetiracetam20 in 1 BOTTLETABLET, FILM COATED205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1636LEVETIRACETAM TABLET, FILM COATED [REDPHARM DRUG, INC.]5Legacy NDC, 1 package rows20210114_88dcbe93-494e-5b74-e053-2a95a90a1eab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311289levETIRAcetam 500 MG Oral TabletPSN88dcbe93-494e-5b74-e053-2a95a90a1eab5
311289levetiracetam 500 MG Oral TabletSCD88dcbe93-494e-5b74-e053-2a95a90a1eab5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-1636-26729616360220 TABLET, FILM COATED in 1 BOTTLE (67296-1636-2) 2019-01-010000-00-00NoNoCurrent