FDA.reportPublic FDA data

ONDANSETRON

Product NDC
23155-549
11-digit product format
231550549
Labeler code
23155
Product ID
23155-549_a9ae0d2e-667a-4c29-8697-32b044725d35
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ONDANSETRON
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA090648
Marketing category
ANDA
Marketing start
2012-06-15
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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ONDANSETRON HYDROCHLORIDE2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNMH84OZK2B
Rxcui283504, 1740467

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
23155-549-31ONDANSETRON20 mL in 1 VIALINJECTION2011
23155-549-31ONDANSETRON1 in 1 CARTONINJECTION111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-549-31ML - Milliliter23155-549b09b2457-80b6-4def-ac78-956ffb9a92ef12015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ONDANSETRON HYDROCHLORIDEACTIVE INGREDIENTNMH84OZK2BONDANSETRON INJECTION [HERITAGE PHARMACEUTICALS]1
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON INJECTION [HERITAGE PHARMACEUTICALS]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPONDANSETRON INJECTION [HERITAGE PHARMACEUTICALS]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TONDANSETRON INJECTION [HERITAGE PHARMACEUTICALS]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHONDANSETRON INJECTION [HERITAGE PHARMACEUTICALS]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XONDANSETRON INJECTION [HERITAGE PHARMACEUTICALS]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRONDANSETRON INJECTION [HERITAGE PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-549ONDANSETRON INJECTION [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]10Current NDC, Legacy NDC, 2 package rows20240626_b746d4db-43e6-4219-9e6b-f53e59581305.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283504ondansetron 2 MG/ML Injectable SolutionPSNb746d4db-43e6-4219-9e6b-f53e5958130511
1740467ondansetron 4 MG in 2 ML InjectionPSNb746d4db-43e6-4219-9e6b-f53e5958130511
17404672 ML ondansetron 2 MG/ML InjectionSCDb746d4db-43e6-4219-9e6b-f53e5958130511
283504ondansetron 2 MG/ML Injectable SolutionSCDb746d4db-43e6-4219-9e6b-f53e5958130511
283504ondansetron (as ondansetron HCl ) 2 MG/ML Injectable SolutionSYb746d4db-43e6-4219-9e6b-f53e5958130511
1740467ondansetron 4 MG per 2 ML InjectionSYb746d4db-43e6-4219-9e6b-f53e5958130511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-549-31231550549311 VIAL in 1 CARTON (23155-549-31) / 20 mL in 1 VIAL1 vial2012-06-150000-00-00NoNoCurrent