FDA.reportPublic FDA data

ONDANSETRON

Product NDC
62135-351
11-digit product format
621350351
Labeler code
62135
Product ID
62135-351_06fce9d8-ee18-4486-e063-6394a90aeeb4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ONDANSETRON
Dosage form
TABLET
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA077303
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
62135-351-05ONDANSETRON500 in 1 BOTTLETABLET5003
62135-351-30ONDANSETRON30 in 1 BOTTLETABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-351ONDANSETRON TABLET [CHARTWELL RX, LLC]3Current NDC, Legacy NDC, 2 package rows20231006_88b7432b-f5a7-40f3-9b0c-e7b125f5103c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSN88b7432b-f5a7-40f3-9b0c-e7b125f5103c3
312086ondansetron HCl 8 MG Oral TabletPSN88b7432b-f5a7-40f3-9b0c-e7b125f5103c3
198052ondansetron 4 MG Oral TabletSCD88b7432b-f5a7-40f3-9b0c-e7b125f5103c3
312086ondansetron 8 MG Oral TabletSCD88b7432b-f5a7-40f3-9b0c-e7b125f5103c3
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY88b7432b-f5a7-40f3-9b0c-e7b125f5103c3
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY88b7432b-f5a7-40f3-9b0c-e7b125f5103c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62135-351-0562135035105500 TABLET in 1 BOTTLE (62135-351-05) 500 tablet2022-04-200000-00-00NoNoCurrent
62135-351-306213503513030 TABLET in 1 BOTTLE (62135-351-30) 30 tablet2022-04-200000-00-00NoNoCurrent