FDA.reportPublic FDA data

Ondansetron Hydrochloride

Product NDC
53002-0571
11-digit product format
530020571
Labeler code
53002
Product ID
53002-0571_9d685f26-f892-40fd-b7cd-1461aca06a4c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA078539
Marketing category
ANDA
Marketing start
2007-07-31
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
53002-0571-12025-01-30C16284748780-1f386c649-d43e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
53002-0571-22025-01-30C16284748780-1f386c649-d43e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
53002-0571-32025-01-30C16284748780-1f386c649-d43e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
53002-0571-42025-01-30C16284748780-1f386c649-d43e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
53002-0571-12023-06-07C16284748780-1f386c649-d43e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
53002-0571-22023-06-07C16284748780-1f386c649-d43e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
53002-0571-32023-06-07C16284748780-1f386c649-d43e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
53002-0571-42023-06-07C16284748780-1f386c649-d43e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
53002-0571-12023-01-30C16284748780-1f386c649-d43e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
53002-0571-22023-01-30C16284748780-1f386c649-d43e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
53002-0571-32023-01-30C16284748780-1f386c649-d43e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
53002-0571-42023-01-30C16284748780-1f386c649-d43e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-0571-1Ondansetron Hydrochloride3 in 1 BOTTLETABLET, FILM COATED33
53002-0571-2Ondansetron Hydrochloride6 in 1 BOTTLETABLET, FILM COATED63
53002-0571-3Ondansetron Hydrochloride10 in 1 BOTTLETABLET, FILM COATED103
53002-0571-4Ondansetron Hydrochloride30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-0571ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]3Legacy NDC, 4 package rows20230609_f1e04ccb-60c4-4f9a-acd7-70b1c9bee036.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSNf1e04ccb-60c4-4f9a-acd7-70b1c9bee0363
198052ondansetron 4 MG Oral TabletSCDf1e04ccb-60c4-4f9a-acd7-70b1c9bee0363
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSYf1e04ccb-60c4-4f9a-acd7-70b1c9bee0363

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-0571-1530020571013 TABLET, FILM COATED in 1 BOTTLE (53002-0571-1) 2019-01-010000-00-00NoNoCurrent
53002-0571-2530020571026 TABLET, FILM COATED in 1 BOTTLE (53002-0571-2) 2019-01-010000-00-00NoNoCurrent
53002-0571-35300205710310 TABLET, FILM COATED in 1 BOTTLE (53002-0571-3) 2019-01-010000-00-00NoNoCurrent
53002-0571-45300205710430 TABLET, FILM COATED in 1 BOTTLE (53002-0571-4) 2019-01-010000-00-00NoNoCurrent