NDC Code(s) : 55154-4567-0
Packager : Cardinal Health 107, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ondansetronondansetron TABLET, ORALLY DISINTEGRATING
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-4567(NDC:62756-240)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ONDANSETRON(UNII: 4AF302ESOS)
(ONDANSETRON - UNII:4AF302ESOS) 		ONDANSETRON4 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME(UNII: Z0H242BBR1)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
GLYCERYL DISTEARATE(UNII: 73071MW2KM)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color WHITE (white to off white) Score no score
Shape OVAL Size 10 mm
Flavor STRAWBERRY Imprint Code 240
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-4567-010 in 1 BAG 08/02/2007
11 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077557 08/02/2007

LABELER - Cardinal Health 107, LLC(118546603)

PRINCIPAL DISPLAY PANEL

Ondansetron Orally Disintegrating Tablets

4 mg

10 Tablets

Bag label