FDA.reportPublic FDA data

Ondansetron Hydrochloride

Product NDC
71335-1357
11-digit product format
713351357
Labeler code
71335
Product ID
71335-1357_d48ed97a-a53e-4757-9712-cc4bf0acd961
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078539
Marketing category
ANDA
Marketing start
2007-07-31
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 Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ONDANSETRON HYDROCHLORIDE8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNMH84OZK2B
Rxcui312086

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
71335-1357-0Ondansetron Hydrochloride5 in 1 BOTTLETABLET, FILM COATED56
71335-1357-1Ondansetron Hydrochloride10 in 1 BOTTLETABLET, FILM COATED106
71335-1357-2Ondansetron Hydrochloride15 in 1 BOTTLETABLET, FILM COATED156
71335-1357-3Ondansetron Hydrochloride4 in 1 BOTTLETABLET, FILM COATED46
71335-1357-4Ondansetron Hydrochloride3 in 1 BOTTLETABLET, FILM COATED36
71335-1357-5Ondansetron Hydrochloride12 in 1 BOTTLETABLET, FILM COATED126
71335-1357-6Ondansetron Hydrochloride20 in 1 BOTTLETABLET, FILM COATED206
71335-1357-7Ondansetron Hydrochloride30 in 1 BOTTLETABLET, FILM COATED306
71335-1357-8Ondansetron Hydrochloride60 in 1 BOTTLETABLET, FILM COATED606
71335-1357-9Ondansetron Hydrochloride6 in 1 BOTTLETABLET, FILM COATED66

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1357-2EA - Each71335-1357d622be3e-0860-4472-90b0-5e9d99bce56712025-09-12
71335-1357-7EA - Each71335-1357a903ad39-da57-4cf1-9ad6-f9bdc5430e8512022-03-09
71335-1357-8EA - Each71335-13571646d231-ea89-46fa-8577-179b4abd4a5d12022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1357ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 10 package rows20240809_115e8fb5-61f5-4719-8eb3-063b7ca194ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312086ondansetron HCl 8 MG Oral TabletPSN115e8fb5-61f5-4719-8eb3-063b7ca194ae6
312086ondansetron 8 MG Oral TabletSCD115e8fb5-61f5-4719-8eb3-063b7ca194ae6
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY115e8fb5-61f5-4719-8eb3-063b7ca194ae6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1357-0713351357005 TABLET, FILM COATED in 1 BOTTLE (71335-1357-0) 2024-04-030000-00-00NoNoCurrent
71335-1357-17133513570110 TABLET, FILM COATED in 1 BOTTLE (71335-1357-1) 2019-10-140000-00-00NoNoCurrent
71335-1357-27133513570215 TABLET, FILM COATED in 1 BOTTLE (71335-1357-2) 2021-07-300000-00-00NoNoCurrent
71335-1357-3713351357034 TABLET, FILM COATED in 1 BOTTLE (71335-1357-3) 2024-04-030000-00-00NoNoCurrent
71335-1357-4713351357043 TABLET, FILM COATED in 1 BOTTLE (71335-1357-4) 2024-04-030000-00-00NoNoCurrent
71335-1357-57133513570512 TABLET, FILM COATED in 1 BOTTLE (71335-1357-5) 2021-09-300000-00-00NoNoCurrent
71335-1357-67133513570620 TABLET, FILM COATED in 1 BOTTLE (71335-1357-6) 2019-09-270000-00-00NoNoCurrent
71335-1357-77133513570730 TABLET, FILM COATED in 1 BOTTLE (71335-1357-7) 2019-10-010000-00-00NoNoCurrent
71335-1357-87133513570860 TABLET, FILM COATED in 1 BOTTLE (71335-1357-8) 2021-07-280000-00-00NoNoCurrent
71335-1357-9713351357096 TABLET, FILM COATED in 1 BOTTLE (71335-1357-9) 2020-02-120000-00-00NoNoCurrent