FDA.reportPublic FDA data

Ondansetron

Product NDC
65219-323
11-digit product format
652190323
Labeler code
65219
Product ID
65219-323_0b0b9b52-bc7d-4c4e-8df5-6c9ab0b268d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ONDANSETRON HYDROCHLORIDE
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA076972
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
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65219-323-00Ondansetron2 mL in 1 VIALINJECTION21
65219-323-02Ondansetron25 in 1 TRAYINJECTION251

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-323-00ML - Milliliter65219-3233852095b-08da-4b2e-bc2e-75616400149412025-05-14
65219-323-02ML - Milliliter65219-323e12894a4-63ca-444a-8b36-2c3c00d7b0d812025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-323ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION [FRESENIUS KABI USA, LLC ]1Current NDC, 2 package rows20231202_6a231919-6837-4b09-b66d-3706432b9702.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1740467ondansetron 4 MG in 2 ML InjectionPSN6a231919-6837-4b09-b66d-3706432b97021
17404672 ML ondansetron 2 MG/ML InjectionSCD6a231919-6837-4b09-b66d-3706432b97021
1740467ondansetron 4 MG per 2 ML InjectionSY6a231919-6837-4b09-b66d-3706432b97021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65219-323-00652190323002 mL in 1 VIAL2 mlHistorical
65219-323-026521903230225 VIAL in 1 TRAY (65219-323-02) / 2 mL in 1 VIAL (65219-323-00) 25 vial2024-01-22NoNoCurrent