ONDANSETRON

Product NDC
70934-448
11-digit product format
709340448
Labeler code
70934
Product ID
70934-448_a799bd22-c212-8575-e053-2a95a90af04f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ONDANSETRON
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA077557
Marketing category
ANDA
Marketing start
2019-09-26
Marketing end
0000-00-00
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
2021-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
4AF302ESOSONDANSETRON99614-02-5ONDANSETRON

Packages

Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70934-448-83709340448834 TABLET, ORALLY DISINTEGRATING in 1 BAG (70934-448-83) 2020-04-080000-00-00NoNoCurrent
70934-448-957093404489510 TABLET, ORALLY DISINTEGRATING in 1 BAG (70934-448-95) 2020-09-260000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Ondansetron Orally Disintegrating TabletsDenton Pharma, Inc. DBA Northwind Pharmaceuticals2020-06-08HUMAN PRESCRIPTION DRUG LABEL1