FDA.reportPublic FDA data

Ondansetron

Product NDC
50090-1659
11-digit product format
500901659
Labeler code
50090
Product ID
50090-1659_b78afa5d-da9c-4dbb-8509-857dc2b89dd0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
A-S Medication Solutions
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
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
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
50090-1659-02023-10-23C16284748780-1f386c64a-394c-0266-e053-dadaa90a7c1aThese 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
50090-1659-02023-10-23C16284748780-1f386c64a-394c-0266-e053-dadaa90a7c1aThese 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
50090-1659-02023-01-30C16284748780-1f386c64a-394c-0266-e053-dadaa90a7c1aThese 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
50090-1659-02023-01-30C16284748780-1f386c64a-394c-0266-e053-dadaa90a7c1aThese 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
50090-1659-0Ondansetron10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1013
50090-1659-0Ondansetron1 in 1 CARTONTABLET, ORALLY DISINTEGRATING113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1659-0EA - Each50090-16590c900953-bac3-4acc-abfa-d98394e6546612018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1659ONDANSETRON TABLET, ORALLY DISINTEGRATING [A-S MEDICATION SOLUTIONS]11Current NDC, Legacy NDC, 2 package rows20231024_02ddd5f5-76d3-4f1c-9af3-d39e05a19c29.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104894ondansetron 4 MG Disintegrating Oral TabletPSN02ddd5f5-76d3-4f1c-9af3-d39e05a19c2913
104894ondansetron 4 MG Disintegrating Oral TabletSCD02ddd5f5-76d3-4f1c-9af3-d39e05a19c2913

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1659-0500901659001 BLISTER PACK in 1 CARTON (50090-1659-0) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK1 blister pack2015-01-230000-00-00NoNoCurrent