FDA.reportPublic FDA data

Ondansetron Hydrochloride

Product NDC
85766-053
11-digit product format
857660053
Labeler code
85766
Product ID
85766-053_502ee59f-cd7a-80c0-e063-6394a90acba4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sportpharm LLC
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ondansetron Hydrochloride
Listing expiration
2027-12-31

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
85766-053-05Ondansetron Hydrochloride5 in 1 BOTTLETABLET, FILM COATED52
85766-053-10Ondansetron Hydrochloride10 in 1 BOTTLETABLET, FILM COATED102
85766-053-14Ondansetron Hydrochloride14 in 1 BOTTLETABLET, FILM COATED142
85766-053-20Ondansetron Hydrochloride20 in 1 BOTTLETABLET, FILM COATED202
85766-053-24Ondansetron Hydrochloride24 in 1 BOTTLETABLET, FILM COATED242
85766-053-30Ondansetron Hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
85766-053-60Ondansetron Hydrochloride60 in 1 BOTTLETABLET, FILM COATED602
85766-053-90Ondansetron Hydrochloride90 in 1 BOTTLETABLET, FILM COATED902

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312086ondansetron HCl 8 MG Oral TabletPSNc0be25a0-e13d-4242-93dc-0b86e82aadd72
312086ondansetron 8 MG Oral TabletSCDc0be25a0-e13d-4242-93dc-0b86e82aadd72
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSYc0be25a0-e13d-4242-93dc-0b86e82aadd72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85766-053-05857660053055 TABLET, FILM COATED in 1 BOTTLE (85766-053-05) 2025-10-01NoNoHistorical
85766-053-108576600531010 TABLET, FILM COATED in 1 BOTTLE (85766-053-10) 2025-10-01NoNoHistorical
85766-053-148576600531414 TABLET, FILM COATED in 1 BOTTLE (85766-053-14) 2025-10-01NoNoHistorical
85766-053-208576600532020 TABLET, FILM COATED in 1 BOTTLE (85766-053-20) 2025-10-01NoNoHistorical
85766-053-248576600532424 TABLET, FILM COATED in 1 BOTTLE (85766-053-24) 2025-10-01NoNoHistorical
85766-053-308576600533030 TABLET, FILM COATED in 1 BOTTLE (85766-053-30) 2025-10-01NoNoHistorical
85766-053-608576600536060 TABLET, FILM COATED in 1 BOTTLE (85766-053-60) 2025-10-01NoNoHistorical
85766-053-908576600539090 TABLET, FILM COATED in 1 BOTTLE (85766-053-90) 2025-10-01NoNoHistorical