ONDANSETRON

Product NDC
23155-548
11-digit product format
231550548
Labeler code
23155
Product ID
23155-548_13c479ff-8168-4358-b65c-3b320691494c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ONDANSETRON
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA079224
Marketing category
ANDA
Marketing start
2015-11-09
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
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
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23155-548-31ONDANSETRON2 mL in 1 VIALINJECTION211
23155-548-41ONDANSETRON10 in 1 CARTONINJECTION1011
23155-548-42ONDANSETRON25 in 1 CARTONINJECTION2511

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-548-31ML - Milliliter23155-5483a198d64-e4c6-4077-afb3-5f0e2b0501aa12016-09-02
23155-548-41ML - Milliliter23155-54888a0580a-f06b-447d-a892-d61ab9c0519f12015-12-02
23155-548-42ML - Milliliter23155-5487fcfad1b-4c1a-4370-a392-988fb5fe4b3412015-12-02

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
23155-548ONDANSETRON INJECTION [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]11Current NDC, Legacy NDC, 3 package rows20240626_8cea2f3a-cfa5-4a68-9ff4-b5a5a2085d08.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283504ondansetron 2 MG/ML Injectable SolutionPSN8cea2f3a-cfa5-4a68-9ff4-b5a5a2085d0811
1740467ondansetron 4 MG in 2 ML InjectionPSN8cea2f3a-cfa5-4a68-9ff4-b5a5a2085d0811
17404672 ML ondansetron 2 MG/ML InjectionSCD8cea2f3a-cfa5-4a68-9ff4-b5a5a2085d0811
283504ondansetron 2 MG/ML Injectable SolutionSCD8cea2f3a-cfa5-4a68-9ff4-b5a5a2085d0811
283504ondansetron (as ondansetron HCl ) 2 MG/ML Injectable SolutionSY8cea2f3a-cfa5-4a68-9ff4-b5a5a2085d0811
1740467ondansetron 4 MG per 2 ML InjectionSY8cea2f3a-cfa5-4a68-9ff4-b5a5a2085d0811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-548-31231550548312 mL in 1 VIAL2 mlHistorical
23155-548-412315505484110 VIAL in 1 CARTON (23155-548-41) / 2 mL in 1 VIAL (23155-548-31) 10 vial2015-11-090000-00-00NoNoCurrent
23155-548-422315505484225 VIAL in 1 CARTON (23155-548-42) / 2 mL in 1 VIAL (23155-548-31) 25 vial2015-11-090000-00-00NoNoCurrent