FDA.reportPublic FDA data

ondansetron

Product NDC
50436-0133
11-digit product format
504360133
Labeler code
50436
Product ID
50436-0133_39d8379b-aa65-4a42-b0e5-13ab68e25573
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Unit Dose Services
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
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
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
50436-0133-12021-01-29C16284748780-1ba0f9c33-2c8e-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON HYDROCHLORIDE tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0133-1ondansetron10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING106
50436-0133-1ondansetron3 in 1 DOSE PACKTABLET, ORALLY DISINTEGRATING36

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-0133-1EA - Each50436-013389613586-48ad-4449-9b3d-041b2bba46d512013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ONDANSETRONACTIVE INGREDIENT4AF302ESOSONDANSETRON TABLET, ORALLY DISINTEGRATING [UNIT DOSE SERVICES]2
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON TABLET, ORALLY DISINTEGRATING [UNIT DOSE SERVICES]2
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1ONDANSETRON TABLET, ORALLY DISINTEGRATING [UNIT DOSE SERVICES]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ONDANSETRON TABLET, ORALLY DISINTEGRATING [UNIT DOSE SERVICES]2
GLYCERYL DISTEARATEINACTIVE INGREDIENT73071MW2KMONDANSETRON TABLET, ORALLY DISINTEGRATING [UNIT DOSE SERVICES]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ONDANSETRON TABLET, ORALLY DISINTEGRATING [UNIT DOSE SERVICES]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AONDANSETRON TABLET, ORALLY DISINTEGRATING [UNIT DOSE SERVICES]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ONDANSETRON TABLET, ORALLY DISINTEGRATING [UNIT DOSE SERVICES]2
TALCINACTIVE INGREDIENT7SEV7J4R1UONDANSETRON TABLET, ORALLY DISINTEGRATING [UNIT DOSE SERVICES]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0133ONDANSETRON TABLET, ORALLY DISINTEGRATING [UNIT DOSE SERVICES]6Legacy NDC, 2 package rows20170512_8d763a30-c778-4560-82a0-91e7b99c8e85.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104894ondansetron 4 MG Disintegrating Oral TabletPSN8d763a30-c778-4560-82a0-91e7b99c8e856
104894ondansetron 4 MG Disintegrating Oral TabletSCD8d763a30-c778-4560-82a0-91e7b99c8e856

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-0133-15043601330110 in 1 BLISTER PACKHistorical