FDA.reportPublic FDA data

Ondansetron

Product NDC
60687-252
11-digit product format
606870252
Labeler code
60687
Product ID
60687-252_43dfaa03-af7d-df4e-e063-6394a90a9f1e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
SOLUTION
Route
ORAL
Labeler
American Health Packaging
Application
ANDA091483
Marketing category
ANDA
Marketing start
2019-02-05
Marketing end
2027-01-31
Substance
ONDANSETRON HYDROCHLORIDE
Active strength
4 mg/5mL
Pharmacologic classes
Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ondansetron
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ONDANSETRON HYDROCHLORIDE4 mg/5mL

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
60687-252-40Ondansetron5 mL in 1 CUP, UNIT-DOSESOLUTION510
60687-252-46Ondansetron10 in 1 TRAYSOLUTION1010
60687-252-86Ondansetron3 in 1 CASESOLUTION310

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-252-40ML - Milliliter60687-252fff1e0d4-f8fc-41ab-9408-bee8420c5db112019-02-13
60687-252-46ML - Milliliter60687-252f339fc5c-dfb6-4593-83b5-71e2ea605b0912019-02-13
60687-252-86ML - Milliliter60687-25229cfca47-9dfd-4852-9f12-f8fb32ce50a312019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-252ONDANSETRON SOLUTION [AMERICAN HEALTH PACKAGING]9Current NDC, Legacy NDC, 3 package rows20250309_92b96072-e8f2-4fd6-aaa0-b73fed214319.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312085ondansetron HCl 4 MG in 5 mL Oral SolutionPSN92b96072-e8f2-4fd6-aaa0-b73fed21431910
312085ondansetron 0.8 MG/ML Oral SolutionSCD92b96072-e8f2-4fd6-aaa0-b73fed21431910
312085ondansetron (as ondansetron HCl dihydrate) 4 MG per 5 ML Oral SolutionSY92b96072-e8f2-4fd6-aaa0-b73fed21431910
312085ondansetron 4 MG per 5 ML Oral SolutionSY92b96072-e8f2-4fd6-aaa0-b73fed21431910

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-252-40606870252405 mL in 1 CUP, UNIT-DOSE5 mlHistorical
60687-252-466068702524610 in 1 TRAYHistorical
60687-252-86606870252863 TRAY in 1 CASE (60687-252-86) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-252-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-252-40) 3 tray2019-02-052027-01-31NoNoCurrent