ONDANSETRON

Product NDC
84549-130
11-digit product format
845490130
Labeler code
84549
Product ID
84549-130_3d5d25eb-8710-ef8c-e063-6394a90a5e03
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ONDANSETRON
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
ProPharma Distribution
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ONDANSETRON
Listing expiration
2026-12-31

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
84549-130-05ONDANSETRON2 mL in 1 VIAL, SINGLE-USEINJECTION21

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1740467ondansetron 4 MG in 2 ML InjectionPSN3d5d25eb-8711-ef8c-e063-6394a90a5e031
17404672 ML ondansetron 2 MG/ML InjectionSCD3d5d25eb-8711-ef8c-e063-6394a90a5e031
1740467ondansetron 4 MG per 2 ML InjectionSY3d5d25eb-8711-ef8c-e063-6394a90a5e031

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84549-130-05845490130052 mL in 1 VIAL, SINGLE-USE (84549-130-05) 2 ml2025-09-01NoNoCurrent