ondansetron

Product NDC
16729-298
11-digit product format
167290298
Labeler code
16729
Product ID
16729-298_424e0911-305e-8eb5-e063-6294a90aaab3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ondansetron
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Accord Healthcare, Inc.
Application
ANDA206846
Marketing category
ANDA
Marketing start
2016-10-20
Substance
ONDANSETRON
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
ONDANSETRON2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4AF302ESOS
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
16729-298-05ondansetron20 mL in 1 VIALINJECTION207

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-298-05ML - Milliliter16729-29801d0e641-4bf7-4bc4-a0fe-b97cd8d6b64212016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-298ONDANSETRON INJECTION [ACCORD HEALTHCARE, INC.]6Current NDC, Legacy NDC, 1 package rows20241006_35e0d160-813f-41d7-a382-d2cab6485d9c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283504ondansetron 2 MG/ML Injectable SolutionPSN35e0d160-813f-41d7-a382-d2cab6485d9c7
283504ondansetron 2 MG/ML Injectable SolutionSCD35e0d160-813f-41d7-a382-d2cab6485d9c7
283504ondansetron (as ondansetron HCl ) 2 MG/ML Injectable SolutionSY35e0d160-813f-41d7-a382-d2cab6485d9c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16729-298-051672902980520 mL in 1 VIAL (16729-298-05) 20 ml2016-10-200000-00-00NoNoCurrent