FDA.reportPublic FDA data

Ondansetron

Product NDC
55154-8339
11-digit product format
551548339
Labeler code
55154
Product ID
55154-8339_536561ac-f104-46f2-abe4-bfb59793ed61
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA090469
Marketing category
ANDA
Marketing start
2024-10-31
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
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
909480fe-0d18-c1c1-a658-0bd9a7131822Product name520170829
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-8339-0Ondansetron1 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING12
55154-8339-0Ondansetron10 in 1 CARTONTABLET, ORALLY DISINTEGRATING102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-8339ONDANSETRON TABLET, ORALLY DISINTEGRATING [CARDINAL HEALTH 107, LLC]1Current NDC, 2 package rows20241103_b50c1767-8a50-49ab-be31-6533021ae7c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312087ondansetron 8 MG Disintegrating Oral TabletPSNb50c1767-8a50-49ab-be31-6533021ae7c42
312087ondansetron 8 MG Disintegrating Oral TabletSCDb50c1767-8a50-49ab-be31-6533021ae7c42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55154-8339-05515483390010 BLISTER PACK in 1 CARTON (55154-8339-0) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK10 blister pack2024-10-31NoNoHistorical