FDA.reportPublic FDA data

Ondansetron

Product NDC
63323-374
11-digit product format
633230374
Labeler code
63323
Product ID
63323-374_83824969-e116-40d6-8940-ff134a4f16c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ONDANSETRON HYDROCHLORIDE
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA076974
Marketing category
ANDA
Marketing start
2009-11-18
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-374-20Ondansetron1 in 1 BOXINJECTION113
63323-374-20Ondansetron20 mL in 1 VIALINJECTION2013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-374-20ML - Milliliter63323-374231486ac-5ea4-4035-84d6-98642be9c4e212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ONDANSETRON HYDROCHLORIDEACTIVE INGREDIENTNMH84OZK2BONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION [FRESENIUS KABI USA, LLC]7
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION [FRESENIUS KABI USA, LLC]7
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION [FRESENIUS KABI USA, LLC]7
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION [FRESENIUS KABI USA, LLC]7
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION [FRESENIUS KABI USA, LLC]7
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION [FRESENIUS KABI USA, LLC]7
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION [FRESENIUS KABI USA, LLC]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-374ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION [FRESENIUS KABI USA, LLC ]13Current NDC, Legacy NDC, 2 package rows20231109_e0050959-c14c-41b6-9a92-fadc5f6feff3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283504ondansetron 2 MG/ML Injectable SolutionPSNe0050959-c14c-41b6-9a92-fadc5f6feff313
1740467ondansetron 4 MG in 2 ML InjectionPSNe0050959-c14c-41b6-9a92-fadc5f6feff313
17404672 ML ondansetron 2 MG/ML InjectionSCDe0050959-c14c-41b6-9a92-fadc5f6feff313
283504ondansetron 2 MG/ML Injectable SolutionSCDe0050959-c14c-41b6-9a92-fadc5f6feff313
283504ondansetron (as ondansetron HCl ) 2 MG/ML Injectable SolutionSYe0050959-c14c-41b6-9a92-fadc5f6feff313
1740467ondansetron 4 MG per 2 ML InjectionSYe0050959-c14c-41b6-9a92-fadc5f6feff313
283504ondansetron 2 MG/ML Injectable SolutionPSNa62e2a6a-6235-7580-e053-2a95a90aa2b02
283504ondansetron 2 MG/ML Injectable SolutionSCDa62e2a6a-6235-7580-e053-2a95a90aa2b02
283504ondansetron (as ondansetron HCl ) 2 MG/ML Injectable SolutionSYa62e2a6a-6235-7580-e053-2a95a90aa2b02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-374-20633230374201 VIAL in 1 BOX (63323-374-20) / 20 mL in 1 VIAL1 vial2009-11-180000-00-00NoNoCurrent