ONDANSETRON

Product NDC
50090-4935
11-digit product format
500904935
Labeler code
50090
Product ID
50090-4935_939b693c-3eb0-406b-abd1-b3fe055cfe35
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ONDANSETRON
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
A-S Medication Solutions
Application
ANDA203711
Marketing category
ANDA
Marketing start
2016-05-26
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4935-0ONDANSETRON25 in 1 CARTONINJECTION2511
50090-4935-0ONDANSETRON2 mL in 1 VIAL, SINGLE-USEINJECTION211

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4935-0ML - Milliliter50090-4935ce1b6c32-bb0e-4455-b92f-3b91080593ce12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4935ONDANSETRON INJECTION [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 2 package rows20230208_b60074e5-8e77-4dc0-9244-4205e4adbaef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1740467ondansetron 4 MG in 2 ML InjectionPSNb60074e5-8e77-4dc0-9244-4205e4adbaef11
17404672 ML ondansetron 2 MG/ML InjectionSCDb60074e5-8e77-4dc0-9244-4205e4adbaef11
1740467ondansetron 4 MG per 2 ML InjectionSYb60074e5-8e77-4dc0-9244-4205e4adbaef11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4935-05009049350025 VIAL, SINGLE-USE in 1 CARTON (50090-4935-0) / 2 mL in 1 VIAL, SINGLE-USE2020-02-270000-00-00NoNoCurrent