ONDANSETRON

Product NDC
42254-097
11-digit product format
422540097
Labeler code
42254
Product ID
42254-097_6c450150-a7a4-46f3-b62a-848eeefada06
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ONDANSETRON
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA077557
Marketing category
ANDA
Marketing start
2007-08-02
Marketing end
0000-00-00
Substance
ONDANSETRON
Active strength
8 mg/1
Pharmacologic classes
Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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
42254-097-102019-09-24C16284748780-19350213a-3c68-c013-e053-90daa90a1393Ondansetron Orally Disintegrating Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-097-10ONDANSETRON10 in 1 BOTTLETABLET, ORALLY DISINTEGRATING101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-097-10EA - Each42254-097c20d7209-387f-42b6-af6f-b49ef07f72bb12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-097ONDANSETRON TABLET, ORALLY DISINTEGRATING [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20120411_6c450150-a7a4-46f3-b62a-848eeefada06.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104894ondansetron 4 MG Disintegrating Oral TabletPSN6c450150-a7a4-46f3-b62a-848eeefada061
312087ondansetron 8 MG Disintegrating Oral TabletPSN6c450150-a7a4-46f3-b62a-848eeefada061
104894ondansetron 4 MG Disintegrating Oral TabletSCD6c450150-a7a4-46f3-b62a-848eeefada061
312087ondansetron 8 MG Disintegrating Oral TabletSCD6c450150-a7a4-46f3-b62a-848eeefada061

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-097-104225400971010 in 1 BOTTLEHistorical