Ondansetron Hydrochloride

Product NDC
72162-2365
11-digit product format
721622365
Labeler code
72162
Product ID
72162-2365_e2d7ce52-5bca-410d-8b24-cb25f1ede451
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
72162-2365-5Ondansetron Hydrochloride500 in 1 BOTTLETABLET, FILM COATED500101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2365-5EA - Each72162-23651c08be3c-e41b-4f8d-9e4b-e16ca81e143612024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2365ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]101Current NDC, 1 package rows20250224_d6694136-7591-4f23-8415-f2aa3c8bab40.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312086ondansetron HCl 8 MG Oral TabletPSNd6694136-7591-4f23-8415-f2aa3c8bab40101
312086ondansetron 8 MG Oral TabletSCDd6694136-7591-4f23-8415-f2aa3c8bab40101
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSYd6694136-7591-4f23-8415-f2aa3c8bab40101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2365-572162236505500 TABLET, FILM COATED in 1 BOTTLE (72162-2365-5) 2024-07-16NoNoHistorical