FDA.reportPublic FDA data

ondansetron

Product NDC
68071-5230
11-digit product format
680715230
Labeler code
68071
Product ID
68071-5230_1b592b2d-916a-154d-e063-6294a90a7ccd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA077557
Marketing category
ANDA
Marketing start
2007-08-02
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ondansetron
Listing expiration
2026-12-31

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
68071-5230-12022-02-07C16284748780-1d6a99b39-3982-a426-e053-dadaa90af4c2These 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
68071-5230-12022-01-28C16284748780-1d6a99b39-3982-a426-e053-dadaa90af4c2These 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
68071-5230-1ondansetron10 in 1 BOXTABLET, ORALLY DISINTEGRATING103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-5230ONDANSETRON TABLET, ORALLY DISINTEGRATING [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 1 package rows20240622_a1dd7420-dd81-2c8e-e053-2995a90ac8e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312087ondansetron 8 MG Disintegrating Oral TabletPSNa1dd7420-dd81-2c8e-e053-2995a90ac8e63
312087ondansetron 8 MG Disintegrating Oral TabletSCDa1dd7420-dd81-2c8e-e053-2995a90ac8e63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-5230-16807152300110 TABLET, ORALLY DISINTEGRATING in 1 BOX (68071-5230-1) 2020-03-270000-00-00NoNoCurrent