Ondansetron

Product NDC
86211-115
11-digit product format
862110115
Labeler code
86211
Product ID
86211-115_adb0171f-4da2-4c95-857b-63d172d10a48
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
JVET PHARMACEUTICALS LLC
Application
ANDA090648
Marketing category
ANDA
Marketing start
2026-03-23
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

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
86211-115-01Ondansetron1 in 1 CARTONINJECTION11
86211-115-01Ondansetron20 mL in 1 VIALINJECTION201

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283504ondansetron 2 MG/ML Injectable SolutionPSN95ca0d81-a0a8-441d-820e-cb6624018a151
283504ondansetron 2 MG/ML Injectable SolutionSCD95ca0d81-a0a8-441d-820e-cb6624018a151
283504ondansetron (as ondansetron HCl ) 2 MG/ML Injectable SolutionSY95ca0d81-a0a8-441d-820e-cb6624018a151

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
86211-115-01862110115011 VIAL in 1 CARTON (86211-115-01) / 20 mL in 1 VIAL1 vial2026-03-23NoNoCurrent