FDA.reportPublic FDA data

Ondansetron

Product NDC
68071-4570
11-digit product format
680714570
Labeler code
68071
Product ID
68071-4570_4915921c-1bef-5676-e063-6394a90a6810
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA090469
Marketing category
ANDA
Marketing start
2010-04-12
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
68071-4570-32024-06-12C16284748780-1ba0f9c33-0e86-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
68071-4570-32023-01-30C16284748780-1ba0f9c33-0e86-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
68071-4570-32021-02-22C16284748780-1ba0f9c33-0e86-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
68071-4570-32021-01-29C16284748780-1ba0f9c33-0e86-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4570-3Ondansetron30 in 1 BOXTABLET, ORALLY DISINTEGRATING305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4570ONDANSETRON TABLET, ORALLY DISINTEGRATING [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 1 package rows20240802_76666e7e-3312-6f9d-e053-2991aa0af705.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312087ondansetron 8 MG Disintegrating Oral TabletPSN76666e7e-3312-6f9d-e053-2991aa0af7055
312087ondansetron 8 MG Disintegrating Oral TabletSCD76666e7e-3312-6f9d-e053-2991aa0af7055

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-4570-36807145700330 TABLET, ORALLY DISINTEGRATING in 1 BOX (68071-4570-3) 2018-09-210000-00-00NoNoCurrent