FDA.reportPublic FDA data

Ondansetron

Product NDC
68788-9559
11-digit product format
687889559
Labeler code
68788
Product ID
68788-9559_f31d49c2-beda-452d-9f36-f1ef89a0eeae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA090469
Marketing category
ANDA
Marketing start
2013-08-27
Substance
ONDANSETRON
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ONDANSETRON8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4AF302ESOS
Rxcui312087

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
68788-9559-1Ondansetron10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1011
68788-9559-3Ondansetron10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1011
68788-9559-3Ondansetron3 in 1 CARTONTABLET, ORALLY DISINTEGRATING311
68788-9559-5Ondansetron5 in 1 BOTTLETABLET, ORALLY DISINTEGRATING511

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ONDANSETRONACTIVE INGREDIENT4AF302ESOSONDANSETRON TABLET, ORALLY DISINTEGRATING [PREFERRED PHARMACEUTICALS, INC.]2
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON TABLET, ORALLY DISINTEGRATING [PREFERRED PHARMACEUTICALS, INC.]2
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1ONDANSETRON TABLET, ORALLY DISINTEGRATING [PREFERRED PHARMACEUTICALS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UONDANSETRON TABLET, ORALLY DISINTEGRATING [PREFERRED PHARMACEUTICALS, INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKONDANSETRON TABLET, ORALLY DISINTEGRATING [PREFERRED PHARMACEUTICALS, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XONDANSETRON TABLET, ORALLY DISINTEGRATING [PREFERRED PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ONDANSETRON TABLET, ORALLY DISINTEGRATING [PREFERRED PHARMACEUTICALS, INC.]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AONDANSETRON TABLET, ORALLY DISINTEGRATING [PREFERRED PHARMACEUTICALS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ONDANSETRON TABLET, ORALLY DISINTEGRATING [PREFERRED PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-9559ONDANSETRON TABLET, ORALLY DISINTEGRATING [PREFERRED PHARMACEUTICALS, INC.]10Current NDC, Legacy NDC, 4 package rows20240726_b9abd5ce-6aca-4fda-8f46-0bb5b7fdd5da.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312087ondansetron 8 MG Disintegrating Oral TabletPSNb9abd5ce-6aca-4fda-8f46-0bb5b7fdd5da11
312087ondansetron 8 MG Disintegrating Oral TabletSCDb9abd5ce-6aca-4fda-8f46-0bb5b7fdd5da11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-9559-16878895590110 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68788-9559-1) 2013-08-270000-00-00NoNoCurrent
68788-9559-3687889559033 BLISTER PACK in 1 CARTON (68788-9559-3) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK3 blister pack2013-08-270000-00-00NoNoCurrent
68788-9559-5687889559055 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68788-9559-5) 2013-08-270000-00-00NoNoCurrent