FDA.reportPublic FDA data

Ondansetron

Product NDC
54838-555
11-digit product format
548380555
Labeler code
54838
Product ID
54838-555_67190fd5-03b4-406d-88fc-5e50c3e03c9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA091342
Marketing category
ANDA
Marketing start
2011-01-27
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
2024-12-31
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54838-555-50ML - Milliliter54838-555bfe8fea8-b365-4770-9b82-059d282bd51312012-07-24

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312085ondansetron HCl 4 MG in 5 mL Oral SolutionPSNf4bad0ab-c501-4728-b3be-9c620e8568fd5
312085ondansetron 0.8 MG/ML Oral SolutionSCDf4bad0ab-c501-4728-b3be-9c620e8568fd5
312085ondansetron (as ondansetron HCl dihydrate) 4 MG per 5 ML Oral SolutionSYf4bad0ab-c501-4728-b3be-9c620e8568fd5
312085ondansetron 4 MG per 5 ML Oral SolutionSYf4bad0ab-c501-4728-b3be-9c620e8568fd5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54838-555-505483805555050 mL in 1 BOTTLE, PLASTIC (54838-555-50) 50 ml2011-01-270000-00-00NoNoCurrent