Ondansetron Hydrochloride

Product NDC
52959-991
11-digit product format
529590991
Labeler code
52959
Product ID
52959-991_100ad196-b283-436d-9e09-40b89418afce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA077517
Marketing category
ANDA
Marketing start
2007-06-25
Marketing end
0000-00-00
Substance
ONDANSETRON HYDROCHLORIDE
Active strength
4 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
52959-991-032019-11-13C16284748780-197449f38-c4f4-f6ea-e053-dbdaa90aa703Ondansetron Hydrochloride Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-991-03Ondansetron Hydrochloride3 in 1 BOTTLETABLET, FILM COATED35

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-991-03EA - Each52959-99153c4f427-d1d0-4a8e-b41a-f50518e9750212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ONDANSETRON HYDROCHLORIDEACTIVE INGREDIENTNMH84OZK2BONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]5
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-991ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]5Legacy NDC, 1 package rows20111221_93f6d82b-0594-4b48-9711-201d79a03315.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSN93f6d82b-0594-4b48-9711-201d79a033155
198052ondansetron 4 MG Oral TabletSCD93f6d82b-0594-4b48-9711-201d79a033155
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY93f6d82b-0594-4b48-9711-201d79a033155

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-991-03529590991033 in 1 BOTTLEHistorical