FDA.reportPublic FDA data

ondansetron

Product NDC
71335-0815
11-digit product format
713350815
Labeler code
71335
Product ID
71335-0815_b638187e-24d5-4c7a-8489-b79e64a2dcfd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ondansetron hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077851
Marketing category
ANDA
Marketing start
2007-06-25
Substance
ONDANSETRON HYDROCHLORIDE
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
ONDANSETRON HYDROCHLORIDE8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNMH84OZK2B
Rxcui198052, 312086

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0815-0ondansetron5 in 1 BOTTLETABLET, FILM COATED55
71335-0815-1ondansetron10 in 1 BOTTLETABLET, FILM COATED105
71335-0815-2ondansetron15 in 1 BOTTLETABLET, FILM COATED155
71335-0815-3ondansetron4 in 1 BOTTLETABLET, FILM COATED45
71335-0815-4ondansetron3 in 1 BOTTLETABLET, FILM COATED35
71335-0815-5ondansetron12 in 1 BOTTLETABLET, FILM COATED125
71335-0815-6ondansetron20 in 1 BOTTLETABLET, FILM COATED205
71335-0815-7ondansetron30 in 1 BOTTLETABLET, FILM COATED305
71335-0815-8ondansetron60 in 1 BOTTLETABLET, FILM COATED605
71335-0815-9ondansetron6 in 1 BOTTLETABLET, FILM COATED65

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0815-7EA - Each71335-0815e03832c5-f23b-4b7c-83f2-7739ec8172ae12018-09-05
71335-0815-8EA - Each71335-0815a86449f7-0aa2-41c8-924c-3966ec4356a112018-09-05
71335-0815-9EA - Each71335-0815afe023db-e843-4530-8f40-79471237891c12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0815ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 10 package rows20190913_37de0550-a6d1-46a8-a0b8-447b0dcf70ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSN37de0550-a6d1-46a8-a0b8-447b0dcf70ad5
312086ondansetron HCl 8 MG Oral TabletPSN37de0550-a6d1-46a8-a0b8-447b0dcf70ad5
198052ondansetron 4 MG Oral TabletSCD37de0550-a6d1-46a8-a0b8-447b0dcf70ad5
312086ondansetron 8 MG Oral TabletSCD37de0550-a6d1-46a8-a0b8-447b0dcf70ad5
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY37de0550-a6d1-46a8-a0b8-447b0dcf70ad5
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY37de0550-a6d1-46a8-a0b8-447b0dcf70ad5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0815-0713350815005 TABLET, FILM COATED in 1 BOTTLE (71335-0815-0) 2012-08-240000-00-00NoNoCurrent
71335-0815-17133508150110 TABLET, FILM COATED in 1 BOTTLE (71335-0815-1) 2012-08-240000-00-00NoNoCurrent
71335-0815-27133508150215 TABLET, FILM COATED in 1 BOTTLE (71335-0815-2) 2012-08-240000-00-00NoNoCurrent
71335-0815-3713350815034 TABLET, FILM COATED in 1 BOTTLE (71335-0815-3) 2012-08-240000-00-00NoNoCurrent
71335-0815-4713350815043 TABLET, FILM COATED in 1 BOTTLE (71335-0815-4) 2012-08-240000-00-00NoNoCurrent
71335-0815-57133508150512 TABLET, FILM COATED in 1 BOTTLE (71335-0815-5) 2012-08-240000-00-00NoNoCurrent
71335-0815-67133508150620 TABLET, FILM COATED in 1 BOTTLE (71335-0815-6) 2012-08-240000-00-00NoNoCurrent
71335-0815-77133508150730 TABLET, FILM COATED in 1 BOTTLE (71335-0815-7) 2012-08-240000-00-00NoNoCurrent
71335-0815-87133508150860 TABLET, FILM COATED in 1 BOTTLE (71335-0815-8) 2012-08-240000-00-00NoNoCurrent
71335-0815-9713350815096 TABLET, FILM COATED in 1 BOTTLE (71335-0815-9) 2012-08-240000-00-00NoNoCurrent