FDA.reportPublic FDA data

Ondansetron

Product NDC
45865-598
11-digit product format
458650598
Labeler code
45865
Product ID
45865-598_9ab33b7d-7056-51b3-e053-2a95a90ad2aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA078152
Marketing category
ANDA
Marketing start
2007-06-27
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d9bd4853-037c-6968-f4d4-9bb9a0efd1eaProduct name220250722
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
32e23bc9-ce14-4555-bb6d-bcb654d7d296Product name120201015
e459f50a-1553-4aab-b6bd-1e5f0c211c49Product name120201015
909480fe-0d18-c1c1-a658-0bd9a7131822Product name520170829
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45865-598-102023-01-30C16284748780-1f386c649-e106-0266-e053-dadaa90a7c1aOndansetron Tablets USP, for oral use Ondansetron Orally Disintegrating Tablets USP, for oral use
45865-598-302023-01-30C16284748780-1f386c649-e106-0266-e053-dadaa90a7c1aOndansetron Tablets USP, for oral use Ondansetron Orally Disintegrating Tablets USP, for oral use

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-598-10Ondansetron10 in 1 BOTTLETABLET, ORALLY DISINTEGRATING102
45865-598-30Ondansetron30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING302

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ONDANSETRONACTIVE INGREDIENT4AF302ESOSONDANSETRON TABLET, ORALLY DISINTEGRATING [MEDSOURCE PHARMACEUTICALS]1
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON TABLET, ORALLY DISINTEGRATING [MEDSOURCE PHARMACEUTICALS]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1ONDANSETRON TABLET, ORALLY DISINTEGRATING [MEDSOURCE PHARMACEUTICALS]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKONDANSETRON TABLET, ORALLY DISINTEGRATING [MEDSOURCE PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ONDANSETRON TABLET, ORALLY DISINTEGRATING [MEDSOURCE PHARMACEUTICALS]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AONDANSETRON TABLET, ORALLY DISINTEGRATING [MEDSOURCE PHARMACEUTICALS]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ONDANSETRON TABLET, ORALLY DISINTEGRATING [MEDSOURCE PHARMACEUTICALS]1
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIONDANSETRON TABLET, ORALLY DISINTEGRATING [MEDSOURCE PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-598ONDANSETRON TABLET, ORALLY DISINTEGRATING [MEDSOURCE PHARMACEUTICALS]2Legacy NDC, 2 package rows20191228_1edf01f7-8cc1-6616-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104894ondansetron 4 MG Disintegrating Oral TabletPSN1edf01f7-8cc1-6616-e054-00144ff88e882
104894ondansetron 4 MG Disintegrating Oral TabletSCD1edf01f7-8cc1-6616-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45865-598-104586505981010 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (45865-598-10) 2015-09-030000-00-00NoNoCurrent
45865-598-304586505983030 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (45865-598-30) 2015-09-030000-00-00NoNoCurrent