FDA.reportPublic FDA data

Ondansetron

Product NDC
50436-4091
11-digit product format
504364091
Labeler code
50436
Product ID
50436-4091_1e45c791-cbd2-419d-bc32-6ef980f3607f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ondansetron hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA077009
Marketing category
ANDA
Marketing start
2007-11-30
Marketing end
0000-00-00
Substance
ONDANSETRON HYDROCHLORIDE
Active strength
4 mg/5mL
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
50436-4091-12021-01-29C16284748780-1ba0f9c33-418e-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ONDANSETRON ORAL SOLUTION safely and effectively. See full prescribing information for ONDANSETRON ORAL SOLUTION ONDANSETRON oral solution Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-4091-1Ondansetron72 in 1 CASESOLUTION722
50436-4091-1Ondansetron5 mL in 1 CUP, UNIT-DOSESOLUTION52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-4091ONDANSETRON (ONDANSETRON HYDROCHLORIDE) SOLUTION [UNIT DOSE SERVICES]2Legacy NDC, 2 package rows20180404_b7dac63f-556b-4965-ae4e-51330a79ab47.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312085ondansetron HCl 4 MG in 5 mL Oral SolutionPSNb7dac63f-556b-4965-ae4e-51330a79ab472
312085ondansetron 0.8 MG/ML Oral SolutionSCDb7dac63f-556b-4965-ae4e-51330a79ab472
312085ondansetron (as ondansetron HCl dihydrate) 4 MG per 5 ML Oral SolutionSYb7dac63f-556b-4965-ae4e-51330a79ab472
312085ondansetron 4 MG per 5 ML Oral SolutionSYb7dac63f-556b-4965-ae4e-51330a79ab472

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-4091-15043640910172 in 1 CASEHistorical