NDC Code(s) : 68788-9550-6
Packager : Preferred Pharmaceuuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Rizatriptan BenzoateRizatriptan Benzoate TABLET, ORALLY DISINTEGRATING
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68788-9550(NDC:60505-3724)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RIZATRIPTAN BENZOATE(UNII: WR978S7QHH)
(RIZATRIPTAN - UNII:51086HBW8G) 		RIZATRIPTAN10 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL(UNII: 3OWL53L36A)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
SUCRALOSE(UNII: 96K6UQ3ZD4)
PEPPERMINT(UNII: V95R5KMY2B)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 3 mm
Flavor Imprint Code APO;RZ;10
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68788-9550-63 in 1 BLISTER PACK Type 0: Not a Combination Product22/10/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202477 10/22/2013

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL – 10 MG BLISTER CARTON LABEL

Apotex Corp. NDC 68788-9550

Repackaged By: Preferred Pharmaceuticals Inc.

Rizatriptan Benzoate Orally Disintegrating Tablets

PHARMACIST: Dispense the enclosed Patient Informaton Leaflet to each patient.

10 mg

Rx only

Rizatriptan Benzoate ODT 10mg