Ondansetron

Product NDC
50090-3839
11-digit product format
500903839
Labeler code
50090
Product ID
50090-3839_6877bdb3-ff22-41a4-8a49-357b1d14e5a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
A-S Medication Solutions
Application
ANDA202600
Marketing category
ANDA
Marketing start
2012-12-21
Marketing end
0000-00-00
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
2021-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3839-0Ondansetron25 in 1 CARTONINJECTION, SOLUTION253
50090-3839-0Ondansetron2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3839ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]3Legacy NDC, 2 package rows20200122_3b8463e6-d501-4c97-9323-130c6c2d9c1c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1740467ondansetron 4 MG in 2 ML InjectionPSN3b8463e6-d501-4c97-9323-130c6c2d9c1c3
17404672 ML ondansetron 2 MG/ML InjectionSCD3b8463e6-d501-4c97-9323-130c6c2d9c1c3
1740467ondansetron 4 MG per 2 ML InjectionSY3b8463e6-d501-4c97-9323-130c6c2d9c1c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3839-05009038390025 VIAL, SINGLE-DOSE in 1 CARTON (50090-3839-0) > 2 mL in 1 VIAL, SINGLE-DOSE2018-11-150000-00-00NoNoCurrent