FDA.reportPublic FDA data

Ondansetron

Product NDC
53002-0570
11-digit product format
530020570
Labeler code
53002
Product ID
53002-0570_a24b048c-c7c1-4698-a7f8-43da2106bedc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA077851
Marketing category
ANDA
Marketing start
2007-07-27
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
2021-12-31
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
53002-0570-12025-01-30C16284748780-19d75b9d0-68bf-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON TABLETS, USP safely and effectively. See full prescribing information for ONDANSETRON TABLETS, USP. ONDANSETRON Tablets USP, for oral use Initial U.S. Approval: 1991
53002-0570-22025-01-30C16284748780-19d75b9d0-68bf-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON TABLETS, USP safely and effectively. See full prescribing information for ONDANSETRON TABLETS, USP. ONDANSETRON Tablets USP, for oral use Initial U.S. Approval: 1991
53002-0570-32025-01-30C16284748780-19d75b9d0-68bf-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON TABLETS, USP safely and effectively. See full prescribing information for ONDANSETRON TABLETS, USP. ONDANSETRON Tablets USP, for oral use Initial U.S. Approval: 1991
53002-0570-42025-01-30C16284748780-19d75b9d0-68bf-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON TABLETS, USP safely and effectively. See full prescribing information for ONDANSETRON TABLETS, USP. ONDANSETRON Tablets USP, for oral use Initial U.S. Approval: 1991
53002-0570-12023-06-07C16284748780-19d75b9d0-68bf-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON TABLETS, USP safely and effectively. See full prescribing information for ONDANSETRON TABLETS, USP. ONDANSETRON Tablets USP, for oral use Initial U.S. Approval: 1991
53002-0570-22023-06-07C16284748780-19d75b9d0-68bf-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON TABLETS, USP safely and effectively. See full prescribing information for ONDANSETRON TABLETS, USP. ONDANSETRON Tablets USP, for oral use Initial U.S. Approval: 1991
53002-0570-32023-06-07C16284748780-19d75b9d0-68bf-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON TABLETS, USP safely and effectively. See full prescribing information for ONDANSETRON TABLETS, USP. ONDANSETRON Tablets USP, for oral use Initial U.S. Approval: 1991
53002-0570-42023-06-07C16284748780-19d75b9d0-68bf-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON TABLETS, USP safely and effectively. See full prescribing information for ONDANSETRON TABLETS, USP. ONDANSETRON Tablets USP, for oral use Initial U.S. Approval: 1991
53002-0570-12023-01-30C16284748780-19d75b9d0-68bf-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON TABLETS, USP safely and effectively. See full prescribing information for ONDANSETRON TABLETS, USP. ONDANSETRON Tablets USP, for oral use Initial U.S. Approval: 1991
53002-0570-22023-01-30C16284748780-19d75b9d0-68bf-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON TABLETS, USP safely and effectively. See full prescribing information for ONDANSETRON TABLETS, USP. ONDANSETRON Tablets USP, for oral use Initial U.S. Approval: 1991
53002-0570-32023-01-30C16284748780-19d75b9d0-68bf-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON TABLETS, USP safely and effectively. See full prescribing information for ONDANSETRON TABLETS, USP. ONDANSETRON Tablets USP, for oral use Initial U.S. Approval: 1991
53002-0570-42023-01-30C16284748780-19d75b9d0-68bf-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON TABLETS, USP safely and effectively. See full prescribing information for ONDANSETRON TABLETS, USP. ONDANSETRON Tablets USP, for oral use Initial U.S. Approval: 1991
53002-0570-12020-12-15C16284748780-19d75b9d0-68bf-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON TABLETS, USP safely and effectively. See full prescribing information for ONDANSETRON TABLETS, USP. ONDANSETRON Tablets USP, for oral use Initial U.S. Approval: 1991
53002-0570-22020-12-15C16284748780-19d75b9d0-68bf-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON TABLETS, USP safely and effectively. See full prescribing information for ONDANSETRON TABLETS, USP. ONDANSETRON Tablets USP, for oral use Initial U.S. Approval: 1991
53002-0570-32020-12-15C16284748780-19d75b9d0-68bf-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON TABLETS, USP safely and effectively. See full prescribing information for ONDANSETRON TABLETS, USP. ONDANSETRON Tablets USP, for oral use Initial U.S. Approval: 1991
53002-0570-42020-12-15C16284748780-19d75b9d0-68bf-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON TABLETS, USP safely and effectively. See full prescribing information for ONDANSETRON TABLETS, USP. ONDANSETRON Tablets USP, for oral use Initial U.S. Approval: 1991
53002-0570-12020-01-31C16284748780-19d75b9d0-68bf-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON TABLETS, USP safely and effectively. See full prescribing information for ONDANSETRON TABLETS, USP. ONDANSETRON Tablets USP, for oral use Initial U.S. Approval: 1991
53002-0570-22020-01-31C16284748780-19d75b9d0-68bf-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON TABLETS, USP safely and effectively. See full prescribing information for ONDANSETRON TABLETS, USP. ONDANSETRON Tablets USP, for oral use Initial U.S. Approval: 1991
53002-0570-32020-01-31C16284748780-19d75b9d0-68bf-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON TABLETS, USP safely and effectively. See full prescribing information for ONDANSETRON TABLETS, USP. ONDANSETRON Tablets USP, for oral use Initial U.S. Approval: 1991
53002-0570-42020-01-31C16284748780-19d75b9d0-68bf-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON TABLETS, USP safely and effectively. See full prescribing information for ONDANSETRON TABLETS, USP. ONDANSETRON Tablets USP, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-0570-1Ondansetron3 in 1 BOTTLETABLET, FILM COATED35
53002-0570-2Ondansetron6 in 1 BOTTLETABLET, FILM COATED65
53002-0570-3Ondansetron10 in 1 BOTTLETABLET, FILM COATED105
53002-0570-4Ondansetron30 in 1 BOTTLETABLET, FILM COATED305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-0570ONDANSETRON TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 4 package rows20230609_4ae18cf9-450f-4b42-a11e-8506b5783f02.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSN4ae18cf9-450f-4b42-a11e-8506b5783f025
198052ondansetron 4 MG Oral TabletSCD4ae18cf9-450f-4b42-a11e-8506b5783f025
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY4ae18cf9-450f-4b42-a11e-8506b5783f025

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-0570-1530020570013 TABLET, FILM COATED in 1 BOTTLE (53002-0570-1) 2017-10-010000-00-00NoNoCurrent
53002-0570-2530020570026 TABLET, FILM COATED in 1 BOTTLE (53002-0570-2) 2017-10-010000-00-00NoNoCurrent
53002-0570-35300205700310 TABLET, FILM COATED in 1 BOTTLE (53002-0570-3) 2017-10-010000-00-00NoNoCurrent
53002-0570-45300205700430 TABLET, FILM COATED in 1 BOTTLE (53002-0570-4) 2017-10-010000-00-00NoNoCurrent