ONDANSETRON

Product NDC
50436-0459
11-digit product format
504360459
Labeler code
50436
Product ID
50436-0459_fbb031d2-6b3c-4f4e-a2a1-523adc9fc576
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ONDANSETRON
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA077851
Marketing category
ANDA
Marketing start
2007-06-25
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
2019-12-31
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
50436-0459-12020-01-31C16284748780-19d75b9d0-6997-f424-e053-dadaa90a57ce2b307a32-6a0c-4ea0-8744-f0231d9bcb4a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0459-1ONDANSETRON30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-0459-1EA - Each50436-0459ae446aaa-23c4-45a6-a349-ec38cb9cf09112018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0459ONDANSETRON TABLET, FILM COATED [UNIT DOSE SERVICES]2Legacy NDC, 1 package rows20180227_2b307a32-6a0c-4ea0-8744-f0231d9bcb4a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312086ondansetron HCl 8 MG Oral TabletPSN2b307a32-6a0c-4ea0-8744-f0231d9bcb4a2
312086ondansetron 8 MG Oral TabletSCD2b307a32-6a0c-4ea0-8744-f0231d9bcb4a2
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY2b307a32-6a0c-4ea0-8744-f0231d9bcb4a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-0459-15043604590130 in 1 BOTTLEHistorical