FDA.reportPublic FDA data

Ondansetron

Product NDC
70166-486
11-digit product format
701660486
Labeler code
70166
Product ID
70166-486_bc2eae60-2bf3-2b2e-e053-2995a90af539
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
SOLUTION
Route
ORAL
Labeler
Lohxa
Application
ANDA091483
Marketing category
ANDA
Marketing start
2010-12-17
Marketing end
0000-00-00
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
2022-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70166-486-022023-01-30C16284748780-1ba0f9c33-5d5a-a910-e053-dadaa90a0b85HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ONDANSETRON ORAL SOLUTION safely and effectively. See full prescribing information for ONDANSETRON ORAL SOLUTION. ONDANSETRON ORAL SOLUTION Initial U.S. Approval: 1991
70166-486-052023-01-30C16284748780-1ba0f9c33-5d5a-a910-e053-dadaa90a0b85HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ONDANSETRON ORAL SOLUTION safely and effectively. See full prescribing information for ONDANSETRON ORAL SOLUTION. ONDANSETRON ORAL SOLUTION Initial U.S. Approval: 1991
70166-486-022021-02-25C16284748780-1ba0f9c33-5d5a-a910-e053-dadaa90a0b85HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ONDANSETRON ORAL SOLUTION safely and effectively. See full prescribing information for ONDANSETRON ORAL SOLUTION. ONDANSETRON ORAL SOLUTION Initial U.S. Approval: 1991
70166-486-052021-02-25C16284748780-1ba0f9c33-5d5a-a910-e053-dadaa90a0b85HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ONDANSETRON ORAL SOLUTION safely and effectively. See full prescribing information for ONDANSETRON ORAL SOLUTION. ONDANSETRON ORAL SOLUTION Initial U.S. Approval: 1991
70166-486-022021-01-29C16284748780-1ba0f9c33-5d5a-a910-e053-dadaa90a0b85HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ONDANSETRON ORAL SOLUTION safely and effectively. See full prescribing information for ONDANSETRON ORAL SOLUTION. ONDANSETRON ORAL SOLUTION Initial U.S. Approval: 1991
70166-486-052021-01-29C16284748780-1ba0f9c33-5d5a-a910-e053-dadaa90a0b85HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ONDANSETRON ORAL SOLUTION safely and effectively. See full prescribing information for ONDANSETRON ORAL SOLUTION. ONDANSETRON ORAL SOLUTION Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70166-486-02Ondansetron2.5 mL in 1 SYRINGE, PLASTICSOLUTION2.52
70166-486-02Ondansetron50 in 1 CARTONSOLUTION502
70166-486-05Ondansetron50 in 1 CARTONSOLUTION502
70166-486-05Ondansetron5 mL in 1 CUP, UNIT-DOSESOLUTION52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70166-486ONDANSETRON SOLUTION [LOHXA]2Legacy NDC, 4 package rows20210226_7f60016c-7c84-4ffa-8adb-2688105b3054.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312085ondansetron HCl 4 MG in 5 mL Oral SolutionPSN7f60016c-7c84-4ffa-8adb-2688105b30542
312085ondansetron 0.8 MG/ML Oral SolutionSCD7f60016c-7c84-4ffa-8adb-2688105b30542
312085ondansetron (as ondansetron HCl dihydrate) 4 MG per 5 ML Oral SolutionSY7f60016c-7c84-4ffa-8adb-2688105b30542
312085ondansetron 4 MG per 5 ML Oral SolutionSY7f60016c-7c84-4ffa-8adb-2688105b30542

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
70166-486-02701660486022.5 mL in 1 SYRINGE, PLASTIC2.5 mlHistorical
70166-486-057016604860550 in 1 CARTONHistorical