FDA.reportPublic FDA data

Ondansetron

Product NDC
68071-4115
11-digit product format
680714115
Labeler code
68071
Product ID
68071-4115_4ef6e0dd-a995-22cf-e063-6394a90add4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA078152
Marketing category
ANDA
Marketing start
2007-06-27
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
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
ONDANSETRON4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4AF302ESOS
Rxcui104894

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
68071-4115-22025-02-03C16284748780-12cef2736-7c63-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
68071-4115-32025-02-03C16284748780-12cef2736-7c63-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
68071-4115-42025-02-03C16284748780-12cef2736-7c63-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
68071-4115-22025-01-30C16284748780-12cef2736-7c63-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
68071-4115-32025-01-30C16284748780-12cef2736-7c63-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
68071-4115-42025-01-30C16284748780-12cef2736-7c63-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4115-2Ondansetron2 in 1 BOTTLETABLET, ORALLY DISINTEGRATING27
68071-4115-3Ondansetron3 in 1 BOTTLETABLET, ORALLY DISINTEGRATING37
68071-4115-4Ondansetron4 in 1 BOTTLETABLET, ORALLY DISINTEGRATING47

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4115ONDANSETRON TABLET, ORALLY DISINTEGRATING [NUCARE PHARMACEUTICALS,INC.]6Current NDC, Legacy NDC, 3 package rows20250205_5bacb621-1261-25d9-e053-2991aa0afa3b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104894ondansetron 4 MG Disintegrating Oral TabletPSN5bacb621-1261-25d9-e053-2991aa0afa3b7
104894ondansetron 4 MG Disintegrating Oral TabletSCD5bacb621-1261-25d9-e053-2991aa0afa3b7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-4115-2680714115022 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68071-4115-2) 2017-10-160000-00-00NoNoCurrent
68071-4115-3680714115033 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68071-4115-3) 2023-06-27NoNoCurrent
68071-4115-4680714115044 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68071-4115-4) 2017-10-160000-00-00NoNoCurrent