FDA.reportPublic FDA data

Ondansetron

Product NDC
50436-0390
11-digit product format
504360390
Labeler code
50436
Product ID
50436-0390_3ce62cae-3300-43ed-a893-e54bf7708056
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA090469
Marketing category
ANDA
Marketing start
2010-04-12
Marketing end
0000-00-00
Substance
ONDANSETRON
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50436-0390-12023-01-30C16284748780-1f386c64a-3022-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0390-1Ondansetron30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-0390-1EA - Each50436-039068e043d1-36c2-4394-85ef-366617aeac5c12021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0390ONDANSETRON TABLET, ORALLY DISINTEGRATING [UNIT DOSE SERVICES]2Legacy NDC, 1 package rows20210905_b2343c64-6a00-4ca8-9c54-33d9a9dc5bc6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104894ondansetron 4 MG Disintegrating Oral TabletPSNb2343c64-6a00-4ca8-9c54-33d9a9dc5bc62
104894ondansetron 4 MG Disintegrating Oral TabletSCDb2343c64-6a00-4ca8-9c54-33d9a9dc5bc62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50436-0390-15043603900130 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (50436-0390-1) 2021-08-300000-00-00NoNoCurrent