FDA.reportPublic FDA data

Ondansetron Hydrochloride

Product NDC
57237-076
11-digit product format
572370076
Labeler code
57237
Product ID
57237-076_523d3416-6472-44c4-abc0-13df8f875e00
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rising Pharma Holdings, 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, 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
57237-076-30Ondansetron Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3011
57237-076-50Ondansetron Hydrochloride500 in 1 BOTTLETABLET, FILM COATED50011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-076-30EA - Each57237-076854d47c4-1281-46bb-a60b-3d2b303b74dd12016-04-04
57237-076-50EA - Each57237-0761400aaf1-7fb0-41eb-bd69-987a90565ff912022-12-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ONDANSETRON HYDROCHLORIDEACTIVE INGREDIENTNMH84OZK2BONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]2
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]2
TRIACETININACTIVE INGREDIENTXHX3C3X673ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-076ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.]10Current NDC, Legacy NDC, 2 package rows20231215_90e0e508-75f7-4c8b-bb38-898aa4c531c3.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
198052ondansetron HCl 4 MG Oral TabletPSN90e0e508-75f7-4c8b-bb38-898aa4c531c311
198052ondansetron HCl 4 MG Oral TabletPSN674ea285-8f84-4603-9655-82200c523fe511
312086ondansetron HCl 8 MG Oral TabletPSN90e0e508-75f7-4c8b-bb38-898aa4c531c311
312086ondansetron HCl 8 MG Oral TabletPSN674ea285-8f84-4603-9655-82200c523fe511
198052ondansetron 4 MG Oral TabletSCD90e0e508-75f7-4c8b-bb38-898aa4c531c311
198052ondansetron 4 MG Oral TabletSCD674ea285-8f84-4603-9655-82200c523fe511
312086ondansetron 8 MG Oral TabletSCD674ea285-8f84-4603-9655-82200c523fe511
312086ondansetron 8 MG Oral TabletSCD90e0e508-75f7-4c8b-bb38-898aa4c531c311
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY674ea285-8f84-4603-9655-82200c523fe511
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY90e0e508-75f7-4c8b-bb38-898aa4c531c311
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY674ea285-8f84-4603-9655-82200c523fe511
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY90e0e508-75f7-4c8b-bb38-898aa4c531c311
312086ondansetron HCl 8 MG Oral TabletPSNaf735f22-6d6c-6e1f-e053-2a95a90a353210
312086ondansetron 8 MG Oral TabletSCDaf735f22-6d6c-6e1f-e053-2a95a90a353210
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSYaf735f22-6d6c-6e1f-e053-2a95a90a353210
312086ondansetron HCl 8 MG Oral TabletPSN5cc67d95-6629-4451-9e34-2f7a60482be58
312086ondansetron 8 MG Oral TabletSCD5cc67d95-6629-4451-9e34-2f7a60482be58
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY5cc67d95-6629-4451-9e34-2f7a60482be58
312086ondansetron HCl 8 MG Oral TabletPSN115e8fb5-61f5-4719-8eb3-063b7ca194ae6
312086ondansetron 8 MG Oral TabletSCD115e8fb5-61f5-4719-8eb3-063b7ca194ae6
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY115e8fb5-61f5-4719-8eb3-063b7ca194ae6
312086ondansetron HCl 8 MG Oral TabletPSNdb99c77a-0b01-9da6-e053-2a95a90a51995
312086ondansetron HCl 8 MG Oral TabletPSN00b17a8e-9d38-a8d4-e063-6294a90a153e5
312086ondansetron 8 MG Oral TabletSCDdb99c77a-0b01-9da6-e053-2a95a90a51995
312086ondansetron 8 MG Oral TabletSCD00b17a8e-9d38-a8d4-e063-6294a90a153e5
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSYdb99c77a-0b01-9da6-e053-2a95a90a51995
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY00b17a8e-9d38-a8d4-e063-6294a90a153e5
312086ondansetron HCl 8 MG Oral TabletPSN7f315229-7e8f-67fd-e053-2a91aa0a8cb63
312086ondansetron HCl 8 MG Oral TabletPSNfbe71308-2927-2467-e053-6394a90aa4193
312086ondansetron HCl 8 MG Oral TabletPSN8d696b8c-eba6-505e-e053-2995a90acb5d3
312086ondansetron HCl 8 MG Oral TabletPSN144cd729-8d1f-4a08-8c29-1daddd4347953
312086ondansetron 8 MG Oral TabletSCD8d696b8c-eba6-505e-e053-2995a90acb5d3
312086ondansetron 8 MG Oral TabletSCD7f315229-7e8f-67fd-e053-2a91aa0a8cb63
312086ondansetron 8 MG Oral TabletSCDfbe71308-2927-2467-e053-6394a90aa4193
312086ondansetron 8 MG Oral TabletSCD144cd729-8d1f-4a08-8c29-1daddd4347953
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSYfbe71308-2927-2467-e053-6394a90aa4193
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY8d696b8c-eba6-505e-e053-2995a90acb5d3
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY144cd729-8d1f-4a08-8c29-1daddd4347953
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY7f315229-7e8f-67fd-e053-2a91aa0a8cb63
312086ondansetron HCl 8 MG Oral TabletPSN2a30d534-4607-4882-865e-56d2364acaad2
312086ondansetron HCl 8 MG Oral TabletPSN65f01335-452e-42c6-a59b-4eb03badc55a2
312086ondansetron 8 MG Oral TabletSCD2a30d534-4607-4882-865e-56d2364acaad2
312086ondansetron 8 MG Oral TabletSCD65f01335-452e-42c6-a59b-4eb03badc55a2
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY2a30d534-4607-4882-865e-56d2364acaad2
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY65f01335-452e-42c6-a59b-4eb03badc55a2
312086ondansetron HCl 8 MG Oral TabletPSN3a76bae2-04c2-ee2d-e063-6394a90ad4c81
312086ondansetron HCl 8 MG Oral TabletPSNebf2ca6f-ee60-48f7-e053-2a95a90adc1c1
312086ondansetron 8 MG Oral TabletSCD3a76bae2-04c2-ee2d-e063-6394a90ad4c81
312086ondansetron 8 MG Oral TabletSCDebf2ca6f-ee60-48f7-e053-2a95a90adc1c1
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY3a76bae2-04c2-ee2d-e063-6394a90ad4c81
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSYebf2ca6f-ee60-48f7-e053-2a95a90adc1c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57237-076-305723700763030 TABLET, FILM COATED in 1 BOTTLE (57237-076-30) 2007-07-310000-00-00NoNoCurrent
57237-076-5057237007650500 TABLET, FILM COATED in 1 BOTTLE (57237-076-50) 2022-10-040000-00-00NoNoCurrent