Ondansetron

Product NDC
33358-512
11-digit product format
333580512
Labeler code
33358
Product ID
33358-512_355a69d9-5b4d-4d6c-be1c-213b9e0ad096
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
RxChange Co.
Application
ANDA090469
Marketing category
ANDA
Marketing start
2014-12-02
Marketing end
0000-00-00
Substance
ONDANSETRON
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
32e23bc9-ce14-4555-bb6d-bcb654d7d296Product name120201015
e459f50a-1553-4aab-b6bd-1e5f0c211c49Product name120201015
909480fe-0d18-c1c1-a658-0bd9a7131822Product name520170829
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33358-512-302020-01-31C16284748780-19d75b9d0-bec9-f424-e053-dadaa90a57ceOndansetron Orally Disintegrating Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33358-512-30Ondansetron30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33358-512-30EA - Each33358-512ccf97ab2-b23d-4f70-81bb-3dd8cebfd85212015-03-03

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33358-512ONDANSETRON TABLET, ORALLY DISINTEGRATING [RXCHANGE CO.]2Legacy NDC, 1 package rows20141202_0e62c438-359f-4cec-a785-9c7ac09fa6f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312087ondansetron 8 MG Disintegrating Oral TabletPSN0e62c438-359f-4cec-a785-9c7ac09fa6f82
312087ondansetron 8 MG Disintegrating Oral TabletSCD0e62c438-359f-4cec-a785-9c7ac09fa6f82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33358-512-303335805123030 in 1 BOTTLEHistorical