FDA.reportPublic FDA data

Ondansetron Hydrochloride

Product NDC
51655-415
11-digit product format
516550415
Labeler code
51655
Product ID
51655-415_4b42c5c3-2626-a1d3-e063-6294a90ab9d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA078539
Marketing category
ANDA
Marketing start
2017-12-07
Substance
ONDANSETRON HYDROCHLORIDE
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 Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ONDANSETRON HYDROCHLORIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNMH84OZK2B
Rxcui198052

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
51655-415-042023-03-27C16284748780-1ba0f9c33-1bbf-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
51655-415-432023-03-27C16284748780-1ba0f9c33-1bbf-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
51655-415-532023-03-27C16284748780-1ba0f9c33-1bbf-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
51655-415-542023-03-27C16284748780-1ba0f9c33-1bbf-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
51655-415-552023-03-27C16284748780-1ba0f9c33-1bbf-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
51655-415-872023-03-27C16284748780-1ba0f9c33-1bbf-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
51655-415-042021-01-29C16284748780-1ba0f9c33-1bbf-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
51655-415-432021-01-29C16284748780-1ba0f9c33-1bbf-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
51655-415-532021-01-29C16284748780-1ba0f9c33-1bbf-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
51655-415-542021-01-29C16284748780-1ba0f9c33-1bbf-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
51655-415-552021-01-29C16284748780-1ba0f9c33-1bbf-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
51655-415-872021-01-29C16284748780-1ba0f9c33-1bbf-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-415-04Ondansetron Hydrochloride4 in 1 BOTTLETABLET, FILM COATED44
51655-415-43Ondansetron Hydrochloride3 in 1 BOTTLETABLET, FILM COATED34
51655-415-53Ondansetron Hydrochloride10 in 1 BOTTLETABLET, FILM COATED104
51655-415-54Ondansetron Hydrochloride15 in 1 BOTTLETABLET, FILM COATED154
51655-415-55Ondansetron Hydrochloride5 in 1 BOTTLETABLET, FILM COATED54
51655-415-87Ondansetron Hydrochloride6 in 1 BOTTLETABLET, FILM COATED64

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-415ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, Legacy NDC, 6 package rows20230328_852a3251-bf28-5557-e053-2991aa0a4fbd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSN852a3251-bf28-5557-e053-2991aa0a4fbd4
198052ondansetron 4 MG Oral TabletSCD852a3251-bf28-5557-e053-2991aa0a4fbd4
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY852a3251-bf28-5557-e053-2991aa0a4fbd4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-415-04516550415044 TABLET, FILM COATED in 1 BOTTLE (51655-415-04) 2018-04-12NoNoCurrent
51655-415-43516550415433 TABLET, FILM COATED in 1 BOTTLE (51655-415-43) 2017-12-28NoNoCurrent
51655-415-535165504155310 TABLET, FILM COATED in 1 BOTTLE (51655-415-53) 2018-04-24NoNoCurrent
51655-415-545165504155415 TABLET, FILM COATED in 1 BOTTLE (51655-415-54) 2017-12-28NoNoCurrent
51655-415-55516550415555 TABLET, FILM COATED in 1 BOTTLE (51655-415-55) 2017-12-07NoNoCurrent
51655-415-87516550415876 TABLET, FILM COATED in 1 BOTTLE (51655-415-87) 2018-10-24NoNoCurrent