FDA.reportPublic FDA data

Ondansetron Hydrochloride

Product NDC
68788-8582
11-digit product format
687888582
Labeler code
68788
Product ID
68788-8582_a1774123-cb6f-4744-9034-657a0cabbeb3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA078539
Marketing category
ANDA
Marketing start
2024-02-12
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
68788-8582-1Ondansetron Hydrochloride10 in 1 BOTTLETABLET, FILM COATED102
68788-8582-2Ondansetron Hydrochloride12 in 1 BOTTLETABLET, FILM COATED122
68788-8582-3Ondansetron Hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
68788-8582-5Ondansetron Hydrochloride15 in 1 BOTTLETABLET, FILM COATED152
68788-8582-6Ondansetron Hydrochloride60 in 1 BOTTLETABLET, FILM COATED602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8582-1EA - Each68788-8582f830d477-43b9-4551-9bf1-f4eba8e119da12024-05-16
68788-8582-2EA - Each68788-8582600b27b6-e7a3-425b-abee-f7cf29c0b66b12024-05-16
68788-8582-3EA - Each68788-8582d5abeabc-a86a-4972-bb7c-cff7256ae2f312024-05-16
68788-8582-5EA - Each68788-858292f745a0-c0c6-4e9c-bfe0-509e524d47c612024-05-16
68788-8582-6EA - Each68788-8582cae8ccbf-68fa-4c3b-af79-c18f9b85205612024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8582ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 5 package rows20240308_2a30d534-4607-4882-865e-56d2364acaad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312086ondansetron HCl 8 MG Oral TabletPSN2a30d534-4607-4882-865e-56d2364acaad2
312086ondansetron 8 MG Oral TabletSCD2a30d534-4607-4882-865e-56d2364acaad2
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY2a30d534-4607-4882-865e-56d2364acaad2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8582-16878885820110 TABLET, FILM COATED in 1 BOTTLE (68788-8582-1) 2024-02-12NoNoHistorical
68788-8582-26878885820212 TABLET, FILM COATED in 1 BOTTLE (68788-8582-2) 2024-02-12NoNoHistorical
68788-8582-36878885820330 TABLET, FILM COATED in 1 BOTTLE (68788-8582-3) 2024-02-12NoNoHistorical
68788-8582-56878885820515 TABLET, FILM COATED in 1 BOTTLE (68788-8582-5) 2024-02-12NoNoHistorical
68788-8582-66878885820660 TABLET, FILM COATED in 1 BOTTLE (68788-8582-6) 2024-02-12NoNoHistorical