NDC Code(s) : 52125-268-02
Packager : REMEDYREPACK INC.

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:52125-268(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:52125-268-0230 in 1 DOSE PACK Type 0: Not a Combination Product06/12/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077557 12/06/2016 12/06/2016

PRINCIPAL DISPLAY PANEL

DRUG: ONDANSETRON

GENERIC: ONDANSETRON

DOSAGE: TABLET, ORALLY DISINTEGRATING

ADMINSTRATION: ORAL

NDC: 52125-268-02

COLOR: white

FLAVOR: STRAWBERRY

SHAPE: OVAL

SCORE: No score

SIZE: 10 mm

IMPRINT: 240

PACKAGING: 30 in 1 DOSE PACK

ACTIVE INGREDIENT(S):

  • ONDANSETRON 4mg in 1

INACTIVE INGREDIENT(S):

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

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