ONDANSETRON

Product NDC
68071-2652
11-digit product format
680712652
Labeler code
68071
Product ID
68071-2652_d9bc4bcd-8467-3b02-e053-2a95a90a635f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ONDANSETRON
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA077557
Marketing category
ANDA
Marketing start
2007-08-02
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
No
Listing certified through
2023-12-31
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
68071-2652-42025-01-30C16284748780-12cef2736-a80d-d83d-e063-dadaa90ab31fOndansetron Orally Disintegrating Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2652-4ONDANSETRON4 in 1 DOSE PACKTABLET, ORALLY DISINTEGRATING41
68071-2652-4ONDANSETRON10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2652ONDANSETRON TABLET, ORALLY DISINTEGRATING [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 2 package rows20220309_d9bc4bcd-8466-3b02-e053-2a95a90a635f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312087ondansetron 8 MG Disintegrating Oral TabletPSNd9bc4bcd-8466-3b02-e053-2a95a90a635f1
312087ondansetron 8 MG Disintegrating Oral TabletSCDd9bc4bcd-8466-3b02-e053-2a95a90a635f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2652-4680712652044 BLISTER PACK in 1 DOSE PACK (68071-2652-4) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK4 blister pack2022-03-080000-00-00NoNoCurrent