FDA.reportPublic FDA data

Ondansetron Hydrochloride

Product NDC
60760-658
11-digit product format
607600658
Labeler code
60760
Product ID
60760-658_4536d878-2855-7b80-e063-6394a90a07ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
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
60760-658-10Ondansetron Hydrochloride10 in 1 BOTTLE, PLASTICTABLET, FILM COATED105
60760-658-15Ondansetron Hydrochloride15 in 1 BOTTLE, PLASTICTABLET, FILM COATED155
60760-658-20Ondansetron Hydrochloride20 in 1 BOTTLE, PLASTICTABLET, FILM COATED205
60760-658-60Ondansetron Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-658-10EA - Each60760-658382745cc-ce99-4b20-9bd0-91874b997f9512023-08-08
60760-658-15EA - Each60760-658d913e912-a6ff-436c-8246-9abd3c5a955212025-10-14
60760-658-20EA - Each60760-65831b05557-f16e-41f7-93fd-e1c0bd80f81a12025-08-11
60760-658-60EA - Each60760-658bb2c34c2-3dd5-4fa4-aed5-29344656c85c12025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-658ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY]1Current NDC, 4 package rows20230718_00b17a8e-9d38-a8d4-e063-6294a90a153e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312086ondansetron HCl 8 MG Oral TabletPSN00b17a8e-9d38-a8d4-e063-6294a90a153e5
312086ondansetron 8 MG Oral TabletSCD00b17a8e-9d38-a8d4-e063-6294a90a153e5
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY00b17a8e-9d38-a8d4-e063-6294a90a153e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60760-658-106076006581010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-658-10) 2023-06-20NoNoCurrent
60760-658-156076006581515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-658-15) 2025-09-15NoNoCurrent
60760-658-206076006582020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-658-20) 2025-06-23NoNoCurrent
60760-658-606076006586060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-658-60) 2025-10-30NoNoCurrent