FDA.reportPublic FDA data

ONDANSETRON HYDROCHLORIDE

Product NDC
55045-3817
11-digit product format
550453817
Labeler code
55045
Product ID
55045-3817_e75fe627-6f74-4e14-8b7e-0b360ebaee22
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ONDANSETRON HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dispensing Solutions, Inc.
Application
ANDA077050
Marketing category
ANDA
Marketing start
2007-06-25
Marketing end
0000-00-00
Substance
ONDANSETRON HYDROCHLORIDE
Active strength
8 mg/1
Pharmacologic classes
Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
55045-3817-32019-11-27C16284748780-19855e2a2-4cd4-60a7-e053-dbdaa90a05bdOndansetron Hydrochloride Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55045-3817-3ONDANSETRON HYDROCHLORIDE30 in 1 BOTTLE, PLASTICTABLET, FILM COATED302

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ONDANSETRON HYDROCHLORIDEACTIVE INGREDIENTNMH84OZK2BONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55045-3817ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2Legacy NDC, 1 package rows20131105_2e57105a-b925-4182-9f70-d0fa0e613051.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSN2e57105a-b925-4182-9f70-d0fa0e6130512
312086ondansetron HCl 8 MG Oral TabletPSN2e57105a-b925-4182-9f70-d0fa0e6130512
198052ondansetron 4 MG Oral TabletSCD2e57105a-b925-4182-9f70-d0fa0e6130512
312086ondansetron 8 MG Oral TabletSCD2e57105a-b925-4182-9f70-d0fa0e6130512
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY2e57105a-b925-4182-9f70-d0fa0e6130512
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY2e57105a-b925-4182-9f70-d0fa0e6130512

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55045-3817-35504538170330 in 1 BOTTLE, PLASTICHistorical