NDC Code(s) : 52125-569-10
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ONDANSETRON ONDANSETRON TABLET, ORALLY DISINTEGRATING
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52125-569(NDC:62756-356)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ONDANSETRON(UNII: 4AF302ESOS)
(ONDANSETRON - UNII:4AF302ESOS) 		ONDANSETRON8 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME(UNII: Z0H242BBR1)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
GLYCERYL DISTEARATE(UNII: 73071MW2KM)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color white Score no score
Shape OVAL (TABLET, ORALLY DISINTEGRATING) Size 13 mm
Flavor Imprint Code 241
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52125-569-106 in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077557 10/14/2014

PRINCIPAL DISPLAY PANEL

DRUG: ONDANSETRON


GENERIC: ONDANSETRON


DOSAGE: TABLET, ORALLY DISINTEGRATING


ADMINSTRATION: ORAL


NDC: 52125-569-10


ACTIVE INGREDIENT(S):

  • ONDANSETRON 8mg in 1


INACTIVE INGREDIENT(S):

  • ASPARTAME
  • MAGNESIUM STEARATE
  • MANNITOL
  • GLYCERYL DISTEARATE
  • CROSCARMELLOSE SODIUM
  • SILICON DIOXIDE
  • TALC


COLOR: white


SHAPE: OVAL


SCORE: No score


SIZE: 13 mm


IMPRINT: 241


PACKAGING: 6 in 1 VIAL




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