Ondansetron

Product NDC
21695-380
11-digit product format
216950380
Labeler code
21695
Product ID
21695-380_1648670a-5567-4e17-ba8d-84583b7973c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA078050
Marketing category
ANDA
Marketing start
2007-08-13
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
21695-380-302019-09-24C16284748780-1934fe258-4aa3-48b1-e053-8cdaa90a720aOndansetron Orally Disintegrating Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-380-30Ondansetron30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-380-30EA - Each21695-380f3ee0f4c-38e8-4d8e-8abb-39e8616f870112012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-380ONDANSETRON TABLET, ORALLY DISINTEGRATING [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 1 package rows20091119_0934b7ad-41c4-418d-86e3-a2ea4e7bb4c7.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-380-302169503803030 in 1 BOTTLEHistorical