FDA.reportPublic FDA data

Ondansetron Hydrochloride

Product NDC
53002-0601
11-digit product format
530020601
Labeler code
53002
Product ID
53002-0601_9f2c3de1-c322-4191-8971-a0bddc49ceb1
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
8 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
53002-0601-12025-01-30C16284748780-1f386c649-ab20-0266-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
53002-0601-22025-01-30C16284748780-1f386c649-ab20-0266-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
53002-0601-32025-01-30C16284748780-1f386c649-ab20-0266-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
53002-0601-42025-01-30C16284748780-1f386c649-ab20-0266-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
53002-0601-12023-06-08C16284748780-1f386c649-ab20-0266-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
53002-0601-22023-06-08C16284748780-1f386c649-ab20-0266-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
53002-0601-32023-06-08C16284748780-1f386c649-ab20-0266-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
53002-0601-42023-06-08C16284748780-1f386c649-ab20-0266-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
53002-0601-12023-01-30C16284748780-1f386c649-ab20-0266-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
53002-0601-22023-01-30C16284748780-1f386c649-ab20-0266-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
53002-0601-32023-01-30C16284748780-1f386c649-ab20-0266-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
53002-0601-42023-01-30C16284748780-1f386c649-ab20-0266-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
53002-0601-1Ondansetron Hydrochloride3 in 1 BOTTLETABLET, FILM COATED33
53002-0601-2Ondansetron Hydrochloride6 in 1 BOTTLETABLET, FILM COATED63
53002-0601-3Ondansetron Hydrochloride10 in 1 BOTTLETABLET, FILM COATED103
53002-0601-4Ondansetron Hydrochloride30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-0601ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]3Legacy NDC, 4 package rows20230609_144cd729-8d1f-4a08-8c29-1daddd434795.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312086ondansetron HCl 8 MG Oral TabletPSN144cd729-8d1f-4a08-8c29-1daddd4347953
312086ondansetron 8 MG Oral TabletSCD144cd729-8d1f-4a08-8c29-1daddd4347953
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY144cd729-8d1f-4a08-8c29-1daddd4347953

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-0601-1530020601013 TABLET, FILM COATED in 1 BOTTLE (53002-0601-1) 2019-01-010000-00-00NoNoCurrent
53002-0601-2530020601026 TABLET, FILM COATED in 1 BOTTLE (53002-0601-2) 2019-01-010000-00-00NoNoCurrent
53002-0601-35300206010310 TABLET, FILM COATED in 1 BOTTLE (53002-0601-3) 2019-01-010000-00-00NoNoCurrent
53002-0601-45300206010430 TABLET, FILM COATED in 1 BOTTLE (53002-0601-4) 2019-01-010000-00-00NoNoCurrent