ONDANSETRON HYDROCHLORIDE

Product NDC
55154-4453
11-digit product format
551544453
Labeler code
55154
Product ID
55154-4453_f61b876e-8d99-407b-89c0-118fa77c8987
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ONDANSETRON HYDROCHLORIDE
Dosage form
SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Cardinal Health 107, LLC
Application
ANDA078287
Marketing category
ANDA
Marketing start
2013-03-13
Substance
ONDANSETRON HYDROCHLORIDE
Active strength
2 mg/mL
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 HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ONDANSETRON HYDROCHLORIDE2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNMH84OZK2B
Rxcui1740467

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
55154-4453-5ONDANSETRON HYDROCHLORIDE5 in 1 BAGSOLUTION56
55154-4453-5ONDANSETRON HYDROCHLORIDE2 mL in 1 VIALSOLUTION26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-4453ONDANSETRON HYDROCHLORIDE SOLUTION [CARDINAL HEALTH 107, LLC]4Current NDC, Legacy NDC, 2 package rows20240207_30107d6f-5128-484f-b713-65244a98dc67.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1740467ondansetron 4 MG in 2 ML InjectionPSN30107d6f-5128-484f-b713-65244a98dc676
17404672 ML ondansetron 2 MG/ML InjectionSCD30107d6f-5128-484f-b713-65244a98dc676
1740467ondansetron 4 MG per 2 ML InjectionSY30107d6f-5128-484f-b713-65244a98dc676

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-4453-5551544453055 VIAL in 1 BAG (55154-4453-5) / 2 mL in 1 VIAL5 vial2013-03-130000-00-00NoNoCurrent