ondansetron

Product NDC
67296-1294
11-digit product format
672961294
Labeler code
67296
Product ID
67296-1294_d6111f7c-6139-392e-e053-2995a90a9b7d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ondansetron
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA077851
Marketing category
ANDA
Marketing start
2007-06-25
Marketing end
0000-00-00
Substance
ONDANSETRON HYDROCHLORIDE
Active strength
4 mg/1
Pharmacologic classes
Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
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
d9bd4853-037c-6968-f4d4-9bb9a0efd1eaProduct name220250722
32e23bc9-ce14-4555-bb6d-bcb654d7d296Product name120201015
e459f50a-1553-4aab-b6bd-1e5f0c211c49Product name120201015
909480fe-0d18-c1c1-a658-0bd9a7131822Product name520170829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1294-32024-01-30C16284748780-11030e365-395b-111a-e063-dadaa90a10e24fcfc585-78de-2dce-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1294-3ondansetron3 in 1 BOTTLETABLET, FILM COATED33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1294ONDANSETRON TABLET, FILM COATED [REDPHARM DRUG, INC.]3Legacy NDC, 1 package rows20220121_4fcfc585-78de-2dce-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSN4fcfc585-78de-2dce-e054-00144ff88e883
198052ondansetron 4 MG Oral TabletSCD4fcfc585-78de-2dce-e054-00144ff88e883
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY4fcfc585-78de-2dce-e054-00144ff88e883

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-1294-3672961294033 TABLET, FILM COATED in 1 BOTTLE (67296-1294-3) 2007-06-250000-00-00NoNoCurrent