Ondansetron

Product NDC
68071-2901
11-digit product format
680712901
Labeler code
68071
Product ID
68071-2901_4bd325a4-0fd4-e343-e063-6394a90a8881
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA078152
Marketing category
ANDA
Marketing start
2007-06-27
Substance
ONDANSETRON
Active strength
4 mg/1
Pharmacologic classes
Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
4AF302ESOSONDANSETRON99614-02-5ONDANSETRON

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-2901-36807129010330 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (68071-2901-3) 2022-12-09NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
OndansetronNuCare Pharmaceuticals,Inc.2026-02-27HUMAN PRESCRIPTION DRUG LABEL2