Ondansetron

Product NDC
55154-3680
11-digit product format
551543680
Labeler code
55154
Product ID
55154-3680_6ce0d9b0-1ce4-4870-b134-cc3ea1187af6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA078152
Marketing category
ANDA
Marketing start
2007-06-27
Substance
ONDANSETRON
Active strength
4 mg/1
Pharmacologic classes
Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ondansetron
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ONDANSETRON4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4AF302ESOS
Rxcui104894

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d9bd4853-037c-6968-f4d4-9bb9a0efd1eaProduct name220250722
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
32e23bc9-ce14-4555-bb6d-bcb654d7d296Product name120201015
e459f50a-1553-4aab-b6bd-1e5f0c211c49Product name120201015
909480fe-0d18-c1c1-a658-0bd9a7131822Product name520170829
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-3680-0Ondansetron10 in 1 BAGTABLET, ORALLY DISINTEGRATING1012
55154-3680-0Ondansetron1 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING112

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-3680ONDANSETRON TABLET, ORALLY DISINTEGRATING [CARDINAL HEALTH 107, LLC]10Current NDC, Legacy NDC, 2 package rows20240207_3c34ca82-9705-4784-be7c-8b50351d14fc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104894ondansetron 4 MG Disintegrating Oral TabletPSN3c34ca82-9705-4784-be7c-8b50351d14fc12
104894ondansetron 4 MG Disintegrating Oral TabletSCD3c34ca82-9705-4784-be7c-8b50351d14fc12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-3680-05515436800010 BLISTER PACK in 1 BAG (55154-3680-0) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK10 blister pack2007-06-270000-00-00NoNoCurrent