FDA.reportPublic FDA data

Ondansetron Hydrochloride

Product NDC
45865-509
11-digit product format
458650509
Labeler code
45865
Product ID
45865-509_7df08e42-5ebe-3938-e053-2991aa0a4cf9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
medsource pharmaceuticals
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
2020-12-31
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
45865-509-302025-01-30C16284748780-12cef2736-817a-d83d-e063-dadaa90ab31fThese 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
45865-509-30Ondansetron Hydrochloride30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-509ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 1 package rows20181227_7df06aee-5db2-9f4c-e053-2a91aa0aa354.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSN7df06aee-5db2-9f4c-e053-2a91aa0aa3541
198052ondansetron 4 MG Oral TabletSCD7df06aee-5db2-9f4c-e053-2a91aa0aa3541
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY7df06aee-5db2-9f4c-e053-2a91aa0aa3541

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45865-509-304586505093030 TABLET, FILM COATED in 1 BOTTLE (45865-509-30) 2018-06-010000-00-00NoNoCurrent