FDA.reportPublic FDA data

Ondansetron

Product NDC
69339-171
11-digit product format
693390171
Labeler code
69339
Product ID
69339-171_8bc7e584-a388-43b6-9627-e58b7b79b2d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET
Route
ORAL
Labeler
Natco Pharma USA LLC
Application
ANDA077851
Marketing category
ANDA
Marketing start
2022-10-24
Substance
ONDANSETRON HYDROCHLORIDE
Active strength
4 mg/1
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/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNMH84OZK2B
Rxcui198052, 312086

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
69339-171-01Ondansetron100 in 1 BOTTLETABLET1003
69339-171-03Ondansetron30 in 1 BOTTLETABLET303
69339-171-05Ondansetron500 in 1 BOTTLETABLET5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69339-171ONDANSETRON TABLET [NATCO PHARMA USA LLC]2Current NDC, Legacy NDC, 3 package rows20230930_64527de5-0b92-4340-9243-7a37e8ff96d9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSN64527de5-0b92-4340-9243-7a37e8ff96d93
312086ondansetron HCl 8 MG Oral TabletPSN64527de5-0b92-4340-9243-7a37e8ff96d93
198052ondansetron 4 MG Oral TabletSCD64527de5-0b92-4340-9243-7a37e8ff96d93
312086ondansetron 8 MG Oral TabletSCD64527de5-0b92-4340-9243-7a37e8ff96d93
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY64527de5-0b92-4340-9243-7a37e8ff96d93
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY64527de5-0b92-4340-9243-7a37e8ff96d93
198052ondansetron HCl 4 MG Oral TabletPSN36592150-7e19-474c-9f96-cc8341e28b5d1
198052ondansetron 4 MG Oral TabletSCD36592150-7e19-474c-9f96-cc8341e28b5d1
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY36592150-7e19-474c-9f96-cc8341e28b5d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69339-171-0169339017101100 TABLET in 1 BOTTLE (69339-171-01) 100 tablet2025-06-27NoNoCurrent
69339-171-036933901710330 TABLET in 1 BOTTLE (69339-171-03) 30 tablet2022-10-240000-00-00NoNoCurrent
69339-171-0569339017105500 TABLET in 1 BOTTLE (69339-171-05) 500 tablet2025-06-270000-00-00NoNoCurrent