FDA.reportPublic FDA data

Ondansetron Hydrochloride

Product NDC
50436-1880
11-digit product format
504361880
Labeler code
50436
Product ID
50436-1880_1fbdf71c-6410-4a60-98b2-05e857587bad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
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
2022-12-31
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
50436-1880-12023-01-30C16284748780-1ba0f9c33-2dab-a910-e053-dadaa90a0b85These 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
50436-1880-12021-09-03C16284748780-1ba0f9c33-2dab-a910-e053-dadaa90a0b85These 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
50436-1880-12021-01-29C16284748780-1ba0f9c33-2dab-a910-e053-dadaa90a0b85These 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
50436-1880-1Ondansetron Hydrochloride30 in 1 BOTTLETABLET, FILM COATED306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-1880-1EA - Each50436-18809aa358a3-ea18-489d-b154-a252802f085712019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-1880ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [UNIT DOSE SERVICES]6Legacy NDC, 1 package rows20210905_0309ecf4-bb8e-439a-9c15-f749f50576bb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSN0309ecf4-bb8e-439a-9c15-f749f50576bb6
312086ondansetron HCl 8 MG Oral TabletPSN0309ecf4-bb8e-439a-9c15-f749f50576bb6
198052ondansetron 4 MG Oral TabletSCD0309ecf4-bb8e-439a-9c15-f749f50576bb6
312086ondansetron 8 MG Oral TabletSCD0309ecf4-bb8e-439a-9c15-f749f50576bb6
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY0309ecf4-bb8e-439a-9c15-f749f50576bb6
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY0309ecf4-bb8e-439a-9c15-f749f50576bb6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50436-1880-15043618800130 TABLET, FILM COATED in 1 BOTTLE (50436-1880-1) 2018-12-040000-00-00NoNoCurrent