Ondansetron

Product NDC
33261-761
11-digit product format
332610761
Labeler code
33261
Product ID
33261-761_c864bb57-bef4-4d7d-91c7-7e70ce696656
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA078152
Marketing category
ANDA
Marketing start
2007-06-27
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
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
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
33261-761-012020-01-31C16284748780-19d75b9d1-24f3-f424-e053-dadaa90a57ceOndansetron Tablets USP Ondansetron Orally Disintegrating Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-761-01Ondansetron10 in 1 BOX, UNIT-DOSETABLET, ORALLY DISINTEGRATING101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-761ONDANSETRON TABLET, ORALLY DISINTEGRATING [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20140128_366b4f74-02aa-4f67-a7cb-7362e60e1052.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104894ondansetron 4 MG Disintegrating Oral TabletPSN366b4f74-02aa-4f67-a7cb-7362e60e10521
312087ondansetron 8 MG Disintegrating Oral TabletPSN366b4f74-02aa-4f67-a7cb-7362e60e10521
104894ondansetron 4 MG Disintegrating Oral TabletSCD366b4f74-02aa-4f67-a7cb-7362e60e10521
312087ondansetron 8 MG Disintegrating Oral TabletSCD366b4f74-02aa-4f67-a7cb-7362e60e10521

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-761-013326107610110 in 1 BOX, UNIT-DOSEHistorical