ONDANSETRON

Product NDC
50090-3769
11-digit product format
500903769
Labeler code
50090
Product ID
50090-3769_e45ce0ef-c557-4286-a97b-e9d7a44a330a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ONDANSETRON
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
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
No
Listing certified through
2019-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3769-0ONDANSETRON4 in 1 BOTTLETABLET, FILM COATED42
50090-3769-1ONDANSETRON10 in 1 BOTTLETABLET, FILM COATED102
50090-3769-3ONDANSETRON30 in 1 BOTTLETABLET, FILM COATED302
50090-3769-4ONDANSETRON6 in 1 BOTTLETABLET, FILM COATED62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3769ONDANSETRON TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]2Legacy NDC, 4 package rows20191001_fdf239e4-9f13-4958-b49f-0757fc825eb8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312086ondansetron HCl 8 MG Oral TabletPSNfdf239e4-9f13-4958-b49f-0757fc825eb82
312086ondansetron 8 MG Oral TabletSCDfdf239e4-9f13-4958-b49f-0757fc825eb82
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSYfdf239e4-9f13-4958-b49f-0757fc825eb82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-3769-0500903769004 in 1 BOTTLEHistorical
50090-3769-15009037690110 in 1 BOTTLEHistorical
50090-3769-35009037690330 in 1 BOTTLEHistorical
50090-3769-4500903769046 in 1 BOTTLEHistorical