FDA.reportPublic FDA data

Ondansetron Hydrochloride

Product NDC
76420-916
11-digit product format
764200916
Labeler code
76420
Product ID
76420-916_2cbe06c2-92c4-f72d-e063-6294a90aede8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Asclemed USA, Inc.
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
Rxcui198052, 312084, 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
76420-916-00Ondansetron Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10001
76420-916-03Ondansetron Hydrochloride3 in 1 BOTTLETABLET, FILM COATED31
76420-916-05Ondansetron Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5001
76420-916-10Ondansetron Hydrochloride10 in 1 BOTTLETABLET, FILM COATED101
76420-916-11Ondansetron Hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED101
76420-916-11Ondansetron Hydrochloride10 in 1 CARTONTABLET, FILM COATED101
76420-916-30Ondansetron Hydrochloride30 in 1 BOTTLETABLET, FILM COATED301
76420-916-33Ondansetron Hydrochloride3 in 1 BLISTER PACKTABLET, FILM COATED31
76420-916-33Ondansetron Hydrochloride1 in 1 CARTONTABLET, FILM COATED11
76420-916-60Ondansetron Hydrochloride60 in 1 BOTTLETABLET, FILM COATED601
76420-916-90Ondansetron Hydrochloride90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-916ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED ONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [ASCLEMED USA, INC.]1Current NDC, 11 package rows20250130_65b0b2e2-37fd-4d08-9674-954d62bb531a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312084ondansetron 24 MG Oral TabletPSN65b0b2e2-37fd-4d08-9674-954d62bb531a1
198052ondansetron HCl 4 MG Oral TabletPSN65b0b2e2-37fd-4d08-9674-954d62bb531a1
312086ondansetron HCl 8 MG Oral TabletPSN65b0b2e2-37fd-4d08-9674-954d62bb531a1
312084ondansetron 24 MG Oral TabletSCD65b0b2e2-37fd-4d08-9674-954d62bb531a1
198052ondansetron 4 MG Oral TabletSCD65b0b2e2-37fd-4d08-9674-954d62bb531a1
312086ondansetron 8 MG Oral TabletSCD65b0b2e2-37fd-4d08-9674-954d62bb531a1
312084ondansetron 24 MG (ondansetron hydrochloride dihydrate 30 MG) Oral TabletSY65b0b2e2-37fd-4d08-9674-954d62bb531a1
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY65b0b2e2-37fd-4d08-9674-954d62bb531a1
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY65b0b2e2-37fd-4d08-9674-954d62bb531a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-916-00764200916001000 TABLET, FILM COATED in 1 BOTTLE (76420-916-00) 2025-01-28NoNoHistorical
76420-916-03764200916033 TABLET, FILM COATED in 1 BOTTLE (76420-916-03) 2025-01-28NoNoHistorical
76420-916-0576420091605500 TABLET, FILM COATED in 1 BOTTLE (76420-916-05) 2025-01-28NoNoHistorical
76420-916-107642009161010 TABLET, FILM COATED in 1 BOTTLE (76420-916-10) 2025-01-28NoNoHistorical
76420-916-117642009161110 BLISTER PACK in 1 CARTON (76420-916-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2025-01-28NoNoHistorical
76420-916-307642009163030 TABLET, FILM COATED in 1 BOTTLE (76420-916-30) 2025-01-28NoNoHistorical
76420-916-33764200916331 BLISTER PACK in 1 CARTON (76420-916-33) / 3 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2025-01-28NoNoHistorical
76420-916-607642009166060 TABLET, FILM COATED in 1 BOTTLE (76420-916-60) 2025-01-28NoNoHistorical
76420-916-907642009169090 TABLET, FILM COATED in 1 BOTTLE (76420-916-90) 2025-01-28NoNoHistorical