NDC Code(s) : 55154-1132-0
Packager : Cardinal Health

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ZOFRANondansetron hydrochloride TABLET, ORALLY DISINTEGRATING
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-1132(NDC:0173-0569)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ondansetron hydrochloride(UNII: NMH84OZK2B)
(ondansetron - UNII:4AF302ESOS)
ondansetron hydrochloride4 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME(UNII: Z0H242BBR1)
gelatin(UNII: 2G86QN327L)
mannitol(UNII: 3OWL53L36A)
METHYLPARABEN SODIUM(UNII: CR6K9C2NHK)
PROPYLPARABEN SODIUM(UNII: 625NNB0G9N)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 14 mm
Flavor STRAWBERRY Imprint Code Z4
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-1132-010 in 1 BAG
11 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020781 01/27/1999

PRINCIPAL DISPLAY PANEL

Zofran ODT®

Ondansetron Orally Disintegrating Tablets

4 mg

10 Tablets

bag label