Ondansetron

Product NDC
45865-105
11-digit product format
458650105
Labeler code
45865
Product ID
45865-105_b72d3b7f-bff3-3ec4-e053-2995a90a67b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA090469
Marketing category
ANDA
Marketing start
2020-07-02
Marketing end
0000-00-00
Substance
ONDANSETRON
Active strength
4 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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-105-30Ondansetron3 in 1 CARTONTABLET, ORALLY DISINTEGRATING31
45865-105-30Ondansetron10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-105ONDANSETRON TABLET, ORALLY DISINTEGRATING [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 2 package rows20201224_b72d3b7f-bff2-3ec4-e053-2995a90a67b0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104894ondansetron 4 MG Disintegrating Oral TabletPSNb72d3b7f-bff2-3ec4-e053-2995a90a67b01
104894ondansetron 4 MG Disintegrating Oral TabletSCDb72d3b7f-bff2-3ec4-e053-2995a90a67b01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-105-30458650105303 BLISTER PACK in 1 CARTON (45865-105-30) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK3 blister pack2020-07-020000-00-00NoNoCurrent