FDA.reportPublic FDA data

Ondansetron

Product NDC
71335-1731
11-digit product format
713351731
Labeler code
71335
Product ID
71335-1731_bc491a5a-1f19-4c2b-85f3-459d571603a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090469
Marketing category
ANDA
Marketing start
2010-04-12
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
71335-1731-0Ondansetron3 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING3105
71335-1731-1Ondansetron30 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING30105
71335-1731-2Ondansetron10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING10105
71335-1731-3Ondansetron5 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING5105
71335-1731-4Ondansetron4 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING4105
71335-1731-5Ondansetron6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING6105
71335-1731-6Ondansetron14 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING14105
71335-1731-7Ondansetron60 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING60105
71335-1731-8Ondansetron12 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING12105
71335-1731-9Ondansetron90 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING90105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1731-1EA - Each71335-17318e4f1114-6f9a-4b8b-bdee-fc4d56f0294d12021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1731ONDANSETRON TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 10 package rows20240829_2d1b8953-7ff5-4e91-ba97-3ba5c6ea8f71.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312087ondansetron 8 MG Disintegrating Oral TabletPSN2d1b8953-7ff5-4e91-ba97-3ba5c6ea8f71105
312087ondansetron 8 MG Disintegrating Oral TabletSCD2d1b8953-7ff5-4e91-ba97-3ba5c6ea8f71105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1731-0713351731003 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-1731-0) 2024-04-040000-00-00NoNoCurrent
71335-1731-17133517310130 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-1731-1) 2021-01-280000-00-00NoNoCurrent
71335-1731-27133517310210 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-1731-2) 2021-01-050000-00-00NoNoCurrent
71335-1731-3713351731035 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-1731-3) 2020-12-290000-00-00NoNoCurrent
71335-1731-4713351731044 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-1731-4) 2021-05-240000-00-00NoNoCurrent
71335-1731-5713351731056 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-1731-5) 2020-12-280000-00-00NoNoCurrent
71335-1731-67133517310614 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-1731-6) 2024-04-040000-00-00NoNoCurrent
71335-1731-77133517310760 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-1731-7) 2024-04-040000-00-00NoNoCurrent
71335-1731-87133517310812 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-1731-8) 2024-04-040000-00-00NoNoCurrent
71335-1731-97133517310990 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-1731-9) 2024-04-040000-00-00NoNoCurrent