FDA.reportPublic FDA data

Ondansetron

Product NDC
80175-0017
11-digit product format
801750017
Labeler code
80175
Product ID
80175-0017_be5ebea5-442c-670e-e053-2995a90a5228
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET
Route
ORAL
Labeler
Central Packaging
Application
ANDA077851
Marketing category
ANDA
Marketing start
2018-07-11
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80175-0017-1Ondansetron10 in 1 BOTTLETABLET102
80175-0017-5Ondansetron30 in 1 BOTTLETABLET302
80175-0017-6Ondansetron60 in 1 BOTTLETABLET602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80175-0017ONDANSETRON TABLET [CENTRAL PACKAGING]2Legacy NDC, 3 package rows20210225_bb2b3155-6271-6d65-e053-2995a90aa3a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSNbb2b3155-6271-6d65-e053-2995a90aa3a12
198052ondansetron 4 MG Oral TabletSCDbb2b3155-6271-6d65-e053-2995a90aa3a12
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSYbb2b3155-6271-6d65-e053-2995a90aa3a12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80175-0017-18017500170110 TABLET in 1 BOTTLE (80175-0017-1) 10 tablet2018-07-110000-00-00NoNoCurrent
80175-0017-380175001703500 TABLET in 1 BOTTLE (80175-0017-3) 500 tablet2018-07-110000-00-00NoNoCurrent
80175-0017-58017500170530 TABLET in 1 BOTTLE (80175-0017-5) 30 tablet2018-07-110000-00-00NoNoCurrent
80175-0017-68017500170660 TABLET in 1 BOTTLE (80175-0017-6) 60 tablet2018-07-110000-00-00NoNoCurrent