FDA.reportPublic FDA data

Ondansetron

Product NDC
50090-1658
11-digit product format
500901658
Labeler code
50090
Product ID
50090-1658_b108bb68-c81b-48a3-876b-e0280f726a1b
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, 312087

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
50090-1658-02023-03-16C16284748780-1f386c649-fa2b-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
50090-1658-02023-03-16C16284748780-1f386c649-fa2b-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
50090-1658-12023-03-16C16284748780-1f386c649-fa2b-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
50090-1658-12023-03-16C16284748780-1f386c649-fa2b-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
50090-1658-22023-03-16C16284748780-1f386c649-fa2b-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
50090-1658-22023-03-16C16284748780-1f386c649-fa2b-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
50090-1658-32023-03-16C16284748780-1f386c649-fa2b-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
50090-1658-32023-03-16C16284748780-1f386c649-fa2b-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
50090-1658-02023-01-30C16284748780-1f386c649-fa2b-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
50090-1658-02023-01-30C16284748780-1f386c649-fa2b-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
50090-1658-12023-01-30C16284748780-1f386c649-fa2b-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
50090-1658-12023-01-30C16284748780-1f386c649-fa2b-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
50090-1658-22023-01-30C16284748780-1f386c649-fa2b-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
50090-1658-22023-01-30C16284748780-1f386c649-fa2b-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
50090-1658-32023-01-30C16284748780-1f386c649-fa2b-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
50090-1658-32023-01-30C16284748780-1f386c649-fa2b-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
50090-1658-0Ondansetron1 in 1 PACKETTABLET, ORALLY DISINTEGRATING121
50090-1658-0Ondansetron10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1021
50090-1658-1Ondansetron1 in 1 PACKETTABLET, ORALLY DISINTEGRATING121
50090-1658-1Ondansetron20 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING2021
50090-1658-2Ondansetron5 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING521
50090-1658-2Ondansetron1 in 1 PACKAGETABLET, ORALLY DISINTEGRATING121
50090-1658-3Ondansetron30 in 1 BOX, UNIT-DOSETABLET, ORALLY DISINTEGRATING3021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1658-0EA - Each50090-1658017e302b-d747-4f1e-8319-76e834c7a70112018-11-06
50090-1658-1EA - Each50090-16580893feae-0043-4f4d-b8d7-2c122231d97f12018-08-13
50090-1658-2EA - Each50090-16584ddeecd5-83b4-4a7c-a788-f82737f8a1b312018-08-13
50090-1658-3EA - Each50090-1658a87e82db-4edc-4694-b741-4ce1575f5b2812018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1658ONDANSETRON TABLET, ORALLY DISINTEGRATING [A-S MEDICATION SOLUTIONS]19Current NDC, Legacy NDC, 7 package rows20230518_5a81a39b-051b-414e-a6b0-d844de4e9ab4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104894ondansetron 4 MG Disintegrating Oral TabletPSN5a81a39b-051b-414e-a6b0-d844de4e9ab421
312087ondansetron 8 MG Disintegrating Oral TabletPSN5a81a39b-051b-414e-a6b0-d844de4e9ab421
104894ondansetron 4 MG Disintegrating Oral TabletSCD5a81a39b-051b-414e-a6b0-d844de4e9ab421
312087ondansetron 8 MG Disintegrating Oral TabletSCD5a81a39b-051b-414e-a6b0-d844de4e9ab421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1658-0500901658001 BLISTER PACK in 1 PACKET (50090-1658-0) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK1 blister pack2015-01-230000-00-00NoNoCurrent
50090-1658-1500901658011 BLISTER PACK in 1 PACKET (50090-1658-1) / 20 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK1 blister pack2015-01-230000-00-00NoNoCurrent
50090-1658-2500901658021 BLISTER PACK in 1 PACKAGE (50090-1658-2) / 5 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK1 blister pack2015-01-23NoNoCurrent
50090-1658-35009016580330 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (50090-1658-3) 2017-01-160000-00-00NoNoCurrent