FDA.reportPublic FDA data

Ondansetron

Product NDC
51672-4091
11-digit product format
516724091
Labeler code
51672
Product ID
51672-4091_e10032ef-6d48-44cb-9b7f-9a338f35ca51
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ondansetron hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Taro Pharmaceuticals U.S.A., Inc.
Application
ANDA077009
Marketing category
ANDA
Marketing start
2007-11-30
Substance
ONDANSETRON HYDROCHLORIDE
Active strength
4 mg/5mL
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 HYDROCHLORIDE4 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNMH84OZK2B
Rxcui312085

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
51672-4091-3Ondansetron1 in 1 CARTONSOLUTION17
51672-4091-3Ondansetron50 mL in 1 BOTTLESOLUTION507

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4091-3ML - Milliliter51672-4091c6bdd593-cc17-434d-9471-2e972a725cd212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Ondansetron HydrochlorideACTIVE INGREDIENTNMH84OZK2BONDANSETRON (ONDANSETRON HYDROCHLORIDE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]4
ondansetronACTIVE MOIETY4AF302ESOSONDANSETRON (ONDANSETRON HYDROCHLORIDE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]4
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLONDANSETRON (ONDANSETRON HYDROCHLORIDE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]4
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUONDANSETRON (ONDANSETRON HYDROCHLORIDE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]4
sucraloseINACTIVE INGREDIENT96K6UQ3ZD4ONDANSETRON (ONDANSETRON HYDROCHLORIDE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]4
trisodium citrate dihydrateINACTIVE INGREDIENTB22547B95KONDANSETRON (ONDANSETRON HYDROCHLORIDE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]4
waterINACTIVE INGREDIENT059QF0KO0RONDANSETRON (ONDANSETRON HYDROCHLORIDE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4091ONDANSETRON (ONDANSETRON HYDROCHLORIDE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]7Current NDC, Legacy NDC, 2 package rows20190607_a95ca4f4-c4de-4822-9a08-209d10bf5136.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312085ondansetron HCl 4 MG in 5 mL Oral SolutionPSNa95ca4f4-c4de-4822-9a08-209d10bf51367
312085ondansetron 0.8 MG/ML Oral SolutionSCDa95ca4f4-c4de-4822-9a08-209d10bf51367
312085ondansetron (as ondansetron HCl dihydrate) 4 MG per 5 ML Oral SolutionSYa95ca4f4-c4de-4822-9a08-209d10bf51367
312085ondansetron 4 MG per 5 ML Oral SolutionSYa95ca4f4-c4de-4822-9a08-209d10bf51367
312085ondansetron HCl 4 MG in 5 mL Oral SolutionPSNb7dac63f-556b-4965-ae4e-51330a79ab472
312085ondansetron 0.8 MG/ML Oral SolutionSCDb7dac63f-556b-4965-ae4e-51330a79ab472
312085ondansetron (as ondansetron HCl dihydrate) 4 MG per 5 ML Oral SolutionSYb7dac63f-556b-4965-ae4e-51330a79ab472
312085ondansetron 4 MG per 5 ML Oral SolutionSYb7dac63f-556b-4965-ae4e-51330a79ab472

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-4091-3516724091031 BOTTLE in 1 CARTON (51672-4091-3) / 50 mL in 1 BOTTLE1 bottle2007-11-300000-00-00NoNoCurrent