FDA.reportPublic FDA data

Ondansetron

Product NDC
53002-0591
11-digit product format
530020591
Labeler code
53002
Product ID
53002-0591_4c58826f-793d-4cd8-97c5-b12072a6db23
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA090469
Marketing category
ANDA
Marketing start
2010-04-12
Marketing end
0000-00-00
Substance
ONDANSETRON
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
53002-0591-12025-01-30C16284748780-1f386c649-e34d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
53002-0591-22025-01-30C16284748780-1f386c649-e34d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
53002-0591-32025-01-30C16284748780-1f386c649-e34d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
53002-0591-42025-01-30C16284748780-1f386c649-e34d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
53002-0591-12023-06-07C16284748780-1f386c649-e34d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
53002-0591-22023-06-07C16284748780-1f386c649-e34d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
53002-0591-32023-06-07C16284748780-1f386c649-e34d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
53002-0591-42023-06-07C16284748780-1f386c649-e34d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
53002-0591-12023-01-30C16284748780-1f386c649-e34d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
53002-0591-22023-01-30C16284748780-1f386c649-e34d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
53002-0591-32023-01-30C16284748780-1f386c649-e34d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
53002-0591-42023-01-30C16284748780-1f386c649-e34d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-0591-1Ondansetron3 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING33
53002-0591-2Ondansetron6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING63
53002-0591-3Ondansetron10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING103
53002-0591-4Ondansetron30 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-0591ONDANSETRON TABLET, ORALLY DISINTEGRATING [RPK PHARMACEUTICALS, INC.]3Legacy NDC, 4 package rows20230609_c0640556-ae39-4b57-9030-03a23dcdb60c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312087ondansetron 8 MG Disintegrating Oral TabletPSNc0640556-ae39-4b57-9030-03a23dcdb60c3
312087ondansetron 8 MG Disintegrating Oral TabletSCDc0640556-ae39-4b57-9030-03a23dcdb60c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-0591-1530020591013 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (53002-0591-1) 2020-01-010000-00-00NoNoCurrent
53002-0591-2530020591026 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (53002-0591-2) 2020-01-010000-00-00NoNoCurrent
53002-0591-35300205910310 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (53002-0591-3) 2020-01-010000-00-00NoNoCurrent
53002-0591-45300205910430 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (53002-0591-4) 2020-01-010000-00-00NoNoCurrent