FDA.reportPublic FDA data

Ondansetron Hydrochloride

Product NDC
68788-8651
11-digit product format
687888651
Labeler code
68788
Product ID
68788-8651_4fecd4f1-85d1-46e3-b5e3-164b04b05e89
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
2024-04-29
Substance
ONDANSETRON HYDROCHLORIDE
Active strength
4 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 HYDROCHLORIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNMH84OZK2B
Rxcui198052

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
68788-8651-1Ondansetron Hydrochloride10 in 1 BOTTLETABLET, FILM COATED102
68788-8651-2Ondansetron Hydrochloride12 in 1 BOTTLETABLET, FILM COATED122
68788-8651-3Ondansetron Hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
68788-8651-5Ondansetron Hydrochloride15 in 1 BOTTLETABLET, FILM COATED152
68788-8651-6Ondansetron Hydrochloride60 in 1 BOTTLETABLET, FILM COATED602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8651-1EA - Each68788-86510ad4f478-61d6-4ca1-99d1-9ffca0f0a44112024-06-10
68788-8651-2EA - Each68788-86512239ec40-07b1-456e-8406-cee93cf1668912024-06-10
68788-8651-3EA - Each68788-865103c3b0e2-21cc-40a4-9515-3b24b1cf9aac12024-06-10
68788-8651-5EA - Each68788-8651322d341d-7c88-4b5c-a833-aa201909545e12024-06-10
68788-8651-6EA - Each68788-86511fd7fea1-f635-43f5-a8cd-f59c8e270e2e12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8651ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 5 package rows20240502_36d64400-2d13-4a1a-a1ca-4741cd3d3f1a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSN36d64400-2d13-4a1a-a1ca-4741cd3d3f1a2
198052ondansetron 4 MG Oral TabletSCD36d64400-2d13-4a1a-a1ca-4741cd3d3f1a2
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY36d64400-2d13-4a1a-a1ca-4741cd3d3f1a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8651-16878886510110 TABLET, FILM COATED in 1 BOTTLE (68788-8651-1) 2024-04-29NoNoHistorical
68788-8651-26878886510212 TABLET, FILM COATED in 1 BOTTLE (68788-8651-2) 2024-04-29NoNoHistorical
68788-8651-36878886510330 TABLET, FILM COATED in 1 BOTTLE (68788-8651-3) 2024-04-29NoNoHistorical
68788-8651-56878886510515 TABLET, FILM COATED in 1 BOTTLE (68788-8651-5) 2024-04-29NoNoHistorical
68788-8651-66878886510660 TABLET, FILM COATED in 1 BOTTLE (68788-8651-6) 2024-04-29NoNoHistorical