FDA.reportPublic FDA data

Ondansetron Hydrochloride

Product NDC
53808-1121
11-digit product format
538081121
Labeler code
53808
Product ID
53808-1121_7f595038-3997-4af0-a235-5448374b1dae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DOH CENTRAL PHARMACY
Application
ANDA078539
Marketing category
ANDA
Marketing start
2017-09-14
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
53808-1121-12024-01-30C16284748780-11030e365-04da-111a-e063-dadaa90a10e2These 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
53808-1121-1Ondansetron Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-1121ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20190123_9b9b3b8f-62e3-4cd6-bc94-bacdf24c825c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSN9b9b3b8f-62e3-4cd6-bc94-bacdf24c825c1
198052ondansetron 4 MG Oral TabletSCD9b9b3b8f-62e3-4cd6-bc94-bacdf24c825c1
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY9b9b3b8f-62e3-4cd6-bc94-bacdf24c825c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53808-1121-15380811210130 TABLET, FILM COATED in 1 BLISTER PACK (53808-1121-1) 2017-09-140000-00-00NoNoCurrent