FDA.reportPublic FDA data

ONDANSETRON

Product NDC
61919-218
11-digit product format
619190218
Labeler code
61919
Product ID
61919-218_3a051a70-853c-4ccf-aa6e-ed429fc6c0f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ONDANSETRON
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
DIRECT RX
Application
ANDA078050
Marketing category
ANDA
Marketing start
2014-01-01
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
61919-218-102020-01-31C16284748780-19d75b9d0-f58c-f424-e053-dadaa90a57ceONDANSETRON

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-218-10ONDANSETRON10 in 1 BOTTLETABLET, ORALLY DISINTEGRATING104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-218-10EA - Each61919-2183d462c85-24df-4be1-919b-d3d9b16d8dfd12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ONDANSETRONACTIVE INGREDIENT4AF302ESOSONDANSETRON TABLET, ORALLY DISINTEGRATING [DIRECT RX]4
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON TABLET, ORALLY DISINTEGRATING [DIRECT RX]4
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1ONDANSETRON TABLET, ORALLY DISINTEGRATING [DIRECT RX]4
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LONDANSETRON TABLET, ORALLY DISINTEGRATING [DIRECT RX]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UONDANSETRON TABLET, ORALLY DISINTEGRATING [DIRECT RX]4
MANNITOLINACTIVE INGREDIENT3OWL53L36AONDANSETRON TABLET, ORALLY DISINTEGRATING [DIRECT RX]4
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQUONDANSETRON TABLET, ORALLY DISINTEGRATING [DIRECT RX]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ONDANSETRON TABLET, ORALLY DISINTEGRATING [DIRECT RX]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ONDANSETRON TABLET, ORALLY DISINTEGRATING [DIRECT RX]4
STRAWBERRYINACTIVE INGREDIENT4J2TY8Y81VONDANSETRON TABLET, ORALLY DISINTEGRATING [DIRECT RX]4
TALCINACTIVE INGREDIENT7SEV7J4R1UONDANSETRON TABLET, ORALLY DISINTEGRATING [DIRECT RX]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-218ONDANSETRON TABLET, ORALLY DISINTEGRATING [DIRECT RX]4Legacy NDC, 1 package rows20150504_14752e63-c7a7-4400-825b-ddab1ab9e782.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312087ondansetron 8 MG Disintegrating Oral TabletPSN14752e63-c7a7-4400-825b-ddab1ab9e7824
312087ondansetron 8 MG Disintegrating Oral TabletSCD14752e63-c7a7-4400-825b-ddab1ab9e7824

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-218-106191902181010 in 1 BOTTLEHistorical