Ondansetron

Product NDC
11819-371
11-digit product format
118190371
Labeler code
11819
Product ID
11819-371_874b1d89-b9a2-815e-e053-2a95a90a1a34
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
United States Department of Health & Human Services
Application
ANDA078139
Marketing category
ANDA
Marketing start
2014-10-27
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
No
Listing certified through
2020-12-31
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
11819-371-01Ondansetron1 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING12
11819-371-28Ondansetron5 in 1 CARTONTABLET, ORALLY DISINTEGRATING52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11819-371ONDANSETRON TABLET, ORALLY DISINTEGRATING [UNITED STATES DEPARTMENT OF HEALTH & HUMAN SERVICES]2Legacy NDC, 2 package rows20190425_7524d455-726d-6318-e053-2a91aa0a202e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312087ondansetron 8 MG Disintegrating Oral TabletPSN7524d455-726d-6318-e053-2a91aa0a202e2
312087ondansetron 8 MG Disintegrating Oral TabletSCD7524d455-726d-6318-e053-2a91aa0a202e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
11819-371-01118190371011 in 1 BLISTER PACKHistorical
11819-371-28118190371285 in 1 CARTONHistorical