Ondansetron

Product NDC
42254-212
11-digit product format
422540212
Labeler code
42254
Product ID
42254-212_c286dba1-e6b1-4cf0-936d-9af42d8eedc3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA078152
Marketing category
ANDA
Marketing start
2007-06-27
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
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
4AF302ESOSONDANSETRON99614-02-5ONDANSETRON

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Ondansetron Tablets USP Ondansetron Orally Disintegrating Tablets USPRebel Distributors Corp2012-05-08HUMAN PRESCRIPTION DRUG LABEL1