Ondansetron

Product NDC
72266-124
11-digit product format
722660124
Labeler code
72266
Product ID
72266-124_3f2b4281-55ef-43e3-e063-6294a90a56ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Fosun Pharma USA Inc.
Application
ANDA090648
Marketing category
ANDA
Marketing start
2019-04-02
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
72266-124-01Ondansetron20 mL in 1 VIALINJECTION207
72266-124-01Ondansetron1 in 1 CARTONINJECTION17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72266-124-01ML - Milliliter72266-1241d549120-8edd-42f1-ab0b-82c6a4e86e7a12019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72266-124ONDANSETRON INJECTION [FOSUN PHARMA USA INC.]6Current NDC, Legacy NDC, 2 package rows20240510_e3f22b7e-b6ad-4799-93c7-d30540cada85.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283504ondansetron 2 MG/ML Injectable SolutionPSNe3f22b7e-b6ad-4799-93c7-d30540cada857
1740467ondansetron 4 MG in 2 ML InjectionPSNe3f22b7e-b6ad-4799-93c7-d30540cada857
17404672 ML ondansetron 2 MG/ML InjectionSCDe3f22b7e-b6ad-4799-93c7-d30540cada857
283504ondansetron 2 MG/ML Injectable SolutionSCDe3f22b7e-b6ad-4799-93c7-d30540cada857
283504ondansetron (as ondansetron HCl ) 2 MG/ML Injectable SolutionSYe3f22b7e-b6ad-4799-93c7-d30540cada857
1740467ondansetron 4 MG per 2 ML InjectionSYe3f22b7e-b6ad-4799-93c7-d30540cada857

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72266-124-01722660124011 VIAL in 1 CARTON (72266-124-01) / 20 mL in 1 VIAL1 vial2019-04-020000-00-00NoNoCurrent