FDA.reportPublic FDA data

ONDANSETRON

Product NDC
63187-693
11-digit product format
631870693
Labeler code
63187
Product ID
63187-693_e9c75381-ef2c-49ec-8a2f-cc445aa5527b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ONDANSETRON
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077557
Marketing category
ANDA
Marketing start
2007-08-02
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ONDANSETRON
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ONDANSETRON8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4AF302ESOS
Rxcui312087

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-693-10ONDANSETRON10 in 1 BOTTLETABLET, ORALLY DISINTEGRATING105
63187-693-15ONDANSETRON15 in 1 BOTTLETABLET, ORALLY DISINTEGRATING155
63187-693-20ONDANSETRON20 in 1 BOTTLETABLET, ORALLY DISINTEGRATING205
63187-693-30ONDANSETRON30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-693ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]5Current NDC, Legacy NDC, 4 package rows20220419_4feb4b89-2d2f-4a9c-a4f4-5ae3e26281b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312087ondansetron 8 MG Disintegrating Oral TabletPSN4feb4b89-2d2f-4a9c-a4f4-5ae3e26281b65
312087ondansetron 8 MG Disintegrating Oral TabletSCD4feb4b89-2d2f-4a9c-a4f4-5ae3e26281b65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-693-106318706931010 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63187-693-10) 2016-04-010000-00-00NoNoCurrent
63187-693-156318706931515 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63187-693-15) 2016-04-010000-00-00NoNoCurrent
63187-693-206318706932020 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63187-693-20) 2016-04-010000-00-00NoNoCurrent
63187-693-306318706933030 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63187-693-30) 2016-04-010000-00-00NoNoCurrent