FDA.reportPublic FDA data

ONDANSETRON

Product NDC
61919-986
11-digit product format
619190986
Labeler code
61919
Product ID
61919-986_4d3a9354-50c1-c926-e063-6394a90ada40
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ONDANSETRON
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Direct Rx
Application
ANDA090469
Marketing category
ANDA
Marketing start
2014-01-01
Substance
ONDANSETRON
Active strength
8 mg/1
Pharmacologic classes
Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ONDANSETRON
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ONDANSETRON8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4AF302ESOS
Rxcui312087

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
61919-986-102025-01-30C16284748780-12cef2736-9d44-d83d-e063-dadaa90ab31fONDANSETRON
61919-986-302025-01-30C16284748780-12cef2736-9d44-d83d-e063-dadaa90ab31fONDANSETRON

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-986-10ONDANSETRON10 in 1 CARTONTABLET, ORALLY DISINTEGRATING106
61919-986-30ONDANSETRON30 in 1 CARTONTABLET, ORALLY DISINTEGRATING306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-986-10EA - Each61919-986d59a4730-86c4-4857-a79c-3dedaf0cd31612016-06-14
61919-986-30EA - Each61919-986cf5df5a0-3d0e-4b4d-a1cd-734c512bd57912014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ONDANSETRONACTIVE INGREDIENT4AF302ESOSONDANSETRON TABLET, ORALLY DISINTEGRATING [DIRECT RX]2
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON TABLET, ORALLY DISINTEGRATING [DIRECT RX]2
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1ONDANSETRON TABLET, ORALLY DISINTEGRATING [DIRECT RX]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKONDANSETRON TABLET, ORALLY DISINTEGRATING [DIRECT RX]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XONDANSETRON TABLET, ORALLY DISINTEGRATING [DIRECT RX]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ONDANSETRON TABLET, ORALLY DISINTEGRATING [DIRECT RX]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AONDANSETRON TABLET, ORALLY DISINTEGRATING [DIRECT RX]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ONDANSETRON TABLET, ORALLY DISINTEGRATING [DIRECT RX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-986ONDANSETRON TABLET, ORALLY DISINTEGRATING [DIRECT RX]5Current NDC, Legacy NDC, 2 package rows20230113_b38feff2-900a-4e0c-8260-8f090edbc0bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312087ondansetron 8 MG Disintegrating Oral TabletPSNb38feff2-900a-4e0c-8260-8f090edbc0bc6
312087ondansetron 8 MG Disintegrating Oral TabletSCDb38feff2-900a-4e0c-8260-8f090edbc0bc6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-986-106191909861010 TABLET, ORALLY DISINTEGRATING in 1 CARTON (61919-986-10) 2014-01-010000-00-00NoNoCurrent
61919-986-306191909863030 TABLET, ORALLY DISINTEGRATING in 1 CARTON (61919-986-30) 2014-01-010000-00-00NoNoCurrent