FDA.reportPublic FDA data

Ondansetron Hydrochloride

Product NDC
68071-2053
11-digit product format
680712053
Labeler code
68071
Product ID
68071-2053_2bae2620-0ac5-7e55-e063-6394a90ad47c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA078539
Marketing category
ANDA
Marketing start
2007-07-31
Substance
ONDANSETRON HYDROCHLORIDE
Active strength
4 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 HYDROCHLORIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNMH84OZK2B
Rxcui198052

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
68071-2053-1Ondansetron Hydrochloride10 in 1 BOTTLETABLET, FILM COATED104
68071-2053-2Ondansetron Hydrochloride20 in 1 BOTTLETABLET, FILM COATED204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2053ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 2 package rows20250116_b43e15d6-b778-7575-e053-2995a90a93a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSNb43e15d6-b778-7575-e053-2995a90a93a04
198052ondansetron 4 MG Oral TabletSCDb43e15d6-b778-7575-e053-2995a90a93a04
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSYb43e15d6-b778-7575-e053-2995a90a93a04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2053-16807120530110 TABLET, FILM COATED in 1 BOTTLE (68071-2053-1) 2020-11-160000-00-00NoNoCurrent
68071-2053-26807120530220 TABLET, FILM COATED in 1 BOTTLE (68071-2053-2) 2025-01-14NoNoHistorical