FDA.reportPublic FDA data

Ondansetron

Product NDC
68071-3268
11-digit product format
680713268
Labeler code
68071
Product ID
68071-3268_4c3bfaa1-85d5-5e53-e063-6294a90a84fd
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
32e23bc9-ce14-4555-bb6d-bcb654d7d296Product name120201015
e459f50a-1553-4aab-b6bd-1e5f0c211c49Product name120201015
909480fe-0d18-c1c1-a658-0bd9a7131822Product name520170829
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-3268-12025-02-04C16284748780-12cef2736-602f-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
68071-3268-22025-02-04C16284748780-12cef2736-602f-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
68071-3268-32025-02-04C16284748780-12cef2736-602f-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
68071-3268-42025-02-04C16284748780-12cef2736-602f-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
68071-3268-52025-02-04C16284748780-12cef2736-602f-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
68071-3268-62025-02-04C16284748780-12cef2736-602f-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
68071-3268-72025-02-04C16284748780-12cef2736-602f-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
68071-3268-12025-01-30C16284748780-12cef2736-602f-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
68071-3268-22025-01-30C16284748780-12cef2736-602f-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
68071-3268-32025-01-30C16284748780-12cef2736-602f-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
68071-3268-42025-01-30C16284748780-12cef2736-602f-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
68071-3268-52025-01-30C16284748780-12cef2736-602f-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
68071-3268-62025-01-30C16284748780-12cef2736-602f-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
68071-3268-72025-01-30C16284748780-12cef2736-602f-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
68071-3268-1Ondansetron10 in 1 BOTTLETABLET, ORALLY DISINTEGRATING108
68071-3268-2Ondansetron2 in 1 BOTTLETABLET, ORALLY DISINTEGRATING28
68071-3268-3Ondansetron3 in 1 BOTTLETABLET, ORALLY DISINTEGRATING38
68071-3268-4Ondansetron4 in 1 BOTTLETABLET, ORALLY DISINTEGRATING48
68071-3268-5Ondansetron5 in 1 BOTTLETABLET, ORALLY DISINTEGRATING58
68071-3268-6Ondansetron6 in 1 BOTTLETABLET, ORALLY DISINTEGRATING68
68071-3268-7Ondansetron20 in 1 BOTTLETABLET, ORALLY DISINTEGRATING208

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3268ONDANSETRON TABLET, ORALLY DISINTEGRATING [NUCARE PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 7 package rows20250206_50383ef5-6e6e-63a7-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104894ondansetron 4 MG Disintegrating Oral TabletPSN50383ef5-6e6e-63a7-e054-00144ff88e888
104894ondansetron 4 MG Disintegrating Oral TabletSCD50383ef5-6e6e-63a7-e054-00144ff88e888

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-3268-16807132680110 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68071-3268-1) 2017-05-230000-00-00NoNoCurrent
68071-3268-2680713268022 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68071-3268-2) 2017-05-230000-00-00NoNoCurrent
68071-3268-3680713268033 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68071-3268-3) 2017-05-230000-00-00NoNoCurrent
68071-3268-4680713268044 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68071-3268-4) 2017-05-230000-00-00NoNoCurrent
68071-3268-5680713268055 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68071-3268-5) 2017-05-23NoNoCurrent
68071-3268-6680713268066 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68071-3268-6) 2017-05-230000-00-00NoNoCurrent
68071-3268-76807132680720 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68071-3268-7) 2017-05-23NoNoCurrent