FDA.reportPublic FDA data

ONDANSETRON HYDROCHLORIDE

Product NDC
36000-012
11-digit product format
360000012
Labeler code
36000
Product ID
36000-012_f917f6a4-bb84-46ed-ba13-68e4c01097e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ONDANSETRON HYDROCHLORIDE
Dosage form
SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Baxter Healthcare Corporation
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ONDANSETRON HYDROCHLORIDE
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36000-012-25ONDANSETRON HYDROCHLORIDE25 in 1 CARTONSOLUTION2522
36000-012-25ONDANSETRON HYDROCHLORIDE2 mL in 1 VIAL, SINGLE-DOSESOLUTION222

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36000-012-25ML - Milliliter36000-0129cf1567e-8d91-4603-a1a1-528085c7c53612013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ONDANSETRON HYDROCHLORIDEACTIVE INGREDIENTNMH84OZK2BONDANSETRON HYDROCHLORIDE SOLUTION [CLARIS LIFESCIENCES INC.]8
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON HYDROCHLORIDE SOLUTION [CLARIS LIFESCIENCES INC.]8
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPONDANSETRON HYDROCHLORIDE SOLUTION [CLARIS LIFESCIENCES INC.]8
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TONDANSETRON HYDROCHLORIDE SOLUTION [CLARIS LIFESCIENCES INC.]8
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHONDANSETRON HYDROCHLORIDE SOLUTION [CLARIS LIFESCIENCES INC.]8
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XONDANSETRON HYDROCHLORIDE SOLUTION [CLARIS LIFESCIENCES INC.]8
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KONDANSETRON HYDROCHLORIDE SOLUTION [CLARIS LIFESCIENCES INC.]8
WATERINACTIVE INGREDIENT059QF0KO0RONDANSETRON HYDROCHLORIDE SOLUTION [CLARIS LIFESCIENCES INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36000-012ONDANSETRON HYDROCHLORIDE SOLUTION [BAXTER HEALTHCARE CORPORATION]20Current NDC, Legacy NDC, 2 package rows20240921_729d865f-d84a-495e-9456-4bceebb6e03f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283504ondansetron 2 MG/ML Injectable SolutionPSN729d865f-d84a-495e-9456-4bceebb6e03f22
1740467ondansetron 4 MG in 2 ML InjectionPSN729d865f-d84a-495e-9456-4bceebb6e03f22
17404672 ML ondansetron 2 MG/ML InjectionSCD729d865f-d84a-495e-9456-4bceebb6e03f22
283504ondansetron 2 MG/ML Injectable SolutionSCD729d865f-d84a-495e-9456-4bceebb6e03f22
283504ondansetron (as ondansetron HCl ) 2 MG/ML Injectable SolutionSY729d865f-d84a-495e-9456-4bceebb6e03f22
1740467ondansetron 4 MG per 2 ML InjectionSY729d865f-d84a-495e-9456-4bceebb6e03f22
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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36000-012-253600000122525 VIAL, SINGLE-DOSE in 1 CARTON (36000-012-25) / 2 mL in 1 VIAL, SINGLE-DOSE2013-03-130000-00-00NoNoCurrent