Ondansetron

Product NDC
75921-459
11-digit product format
759210459
Labeler code
75921
Product ID
75921-459_0e655e4b-acb1-4326-8204-44c406a0c4eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Life Line Home Care Services, Inc.
Application
ANDA077851
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
75921-459-102019-11-13C16284748780-197449f38-cf4d-f6ea-e053-dbdaa90aa7032e5372a6-718e-49d4-a312-04a7f4498b4b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75921-459-10Ondansetron10 in 1 BOTTLETABLET, FILM COATED101

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75921-459ONDANSETRON TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.]1Legacy NDC, 1 package rows20120302_2e5372a6-718e-49d4-a312-04a7f4498b4b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312086ondansetron HCl 8 MG Oral TabletPSN2e5372a6-718e-49d4-a312-04a7f4498b4b1
312086ondansetron 8 MG Oral TabletSCD2e5372a6-718e-49d4-a312-04a7f4498b4b1
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY2e5372a6-718e-49d4-a312-04a7f4498b4b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
75921-459-107592104591010 in 1 BOTTLEHistorical