Ondansetron

Product NDC
71335-2973
11-digit product format
713352973
Labeler code
71335
Product ID
71335-2973_0d752116-b9e4-4ee6-a395-0e4a83f892dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209389
Marketing category
ANDA
Marketing start
2025-06-19
Substance
ONDANSETRON
Active strength
8 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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
4AF302ESOSONDANSETRON99614-02-5ONDANSETRON

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2973-17133529730190 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-2973-1) 2025-11-06NoNoHistorical
71335-2973-27133529730260 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-2973-2) 2025-11-06NoNoHistorical
71335-2973-37133529730330 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-2973-3) 2025-11-06NoNoHistorical
71335-2973-47133529730414 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-2973-4) 2025-11-06NoNoHistorical
71335-2973-57133529730512 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-2973-5) 2025-11-06NoNoHistorical
71335-2973-67133529730610 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-2973-6) 2025-11-06NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
OndansetronBryant Ranch Prepack2025-11-06HUMAN PRESCRIPTION DRUG LABEL1