ONDANSETRON

Product NDC
70934-448
11-digit product format
709340448
Labeler code
70934
Product ID
70934-448_a799bd22-c212-8575-e053-2a95a90af04f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ONDANSETRON
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA077557
Marketing category
ANDA
Marketing start
2019-09-26
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
2021-12-31
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
70934-448-832022-01-28C16284748780-1d6a99b39-44ea-a426-e053-dadaa90af4c2Ondansetron Orally Disintegrating Tablets
70934-448-952022-01-28C16284748780-1d6a99b39-44ea-a426-e053-dadaa90af4c2Ondansetron Orally Disintegrating Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-448-83ONDANSETRON4 in 1 BAGTABLET, ORALLY DISINTEGRATING41
70934-448-95ONDANSETRON10 in 1 BAGTABLET, ORALLY DISINTEGRATING101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-448ONDANSETRON TABLET, ORALLY DISINTEGRATING [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]1Legacy NDC, 2 package rows20200819_a799a6ec-917a-33c9-e053-2995a90a2df3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312087ondansetron 8 MG Disintegrating Oral TabletPSNa799a6ec-917a-33c9-e053-2995a90a2df31
312087ondansetron 8 MG Disintegrating Oral TabletSCDa799a6ec-917a-33c9-e053-2995a90a2df31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70934-448-83709340448834 TABLET, ORALLY DISINTEGRATING in 1 BAG (70934-448-83) 2020-04-080000-00-00NoNoCurrent
70934-448-957093404489510 TABLET, ORALLY DISINTEGRATING in 1 BAG (70934-448-95) 2020-09-260000-00-00NoNoCurrent