ONDANSETRON

Product NDC
42254-077
11-digit product format
422540077
Labeler code
42254
Product ID
42254-077_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
4 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
42254-077-102019-09-24C16284748780-19350213a-3c68-c013-e053-90daa90a1393Ondansetron Orally Disintegrating Tablets
42254-077-302019-09-24C16284748780-19350213a-3c68-c013-e053-90daa90a1393Ondansetron Orally Disintegrating Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-077-10ONDANSETRON10 in 1 BOTTLETABLET, ORALLY DISINTEGRATING101
42254-077-30ONDANSETRON30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-077-10EA - Each42254-0775492bcfd-74a2-4990-ba0b-c4970e63769612012-07-24
42254-077-30EA - Each42254-0771145ee90-9848-4105-b3c6-b87ce7b1530712012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-077ONDANSETRON TABLET, ORALLY DISINTEGRATING [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 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
42254-077-104225400771010 in 1 BOTTLEHistorical
42254-077-304225400773030 in 1 BOTTLEHistorical