Ondansetron

Product NDC
85766-199
11-digit product format
857660199
Labeler code
85766
Product ID
85766-199_4f67ae3e-8c47-3c88-e063-6294a90a64d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ONDANSETRON
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Sportpharm LLC
Application
ANDA077473
Marketing category
ANDA
Marketing start
2006-11-07
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85766-199-20Ondansetron1 in 1 CARTONINJECTION, SOLUTION11
85766-199-20Ondansetron20 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION201

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283504ondansetron 2 MG/ML Injectable SolutionPSN98c1413c-ff7f-4554-9e9f-289038b39ca61
283504ondansetron 2 MG/ML Injectable SolutionSCD98c1413c-ff7f-4554-9e9f-289038b39ca61
283504ondansetron (as ondansetron HCl ) 2 MG/ML Injectable SolutionSY98c1413c-ff7f-4554-9e9f-289038b39ca61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85766-199-20857660199201 VIAL, MULTI-DOSE in 1 CARTON (85766-199-20) / 20 mL in 1 VIAL, MULTI-DOSE2026-04-14NoNoHistorical