NDC Code(s) : 60505-0404-5
Packager : Apotex Corp.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

aripiprazolearipiprazole SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-0404
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARIPIPRAZOLE(UNII: 82VFR53I78)
(ARIPIPRAZOLE - UNII:82VFR53I78) 		ARIPIPRAZOLE1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
FRUCTOSE(UNII: 6YSS42VSEV)200 mg in 1 mL
GLYCERIN(UNII: PDC6A3C0OX)
MALIC ACID(UNII: 817L1N4CKP)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
SUCROSE(UNII: C151H8M554)400 mg in 1 mL
WATER(UNII: 059QF0KO0R)
EDETATE DISODIUM(UNII: 7FLD91C86K)
ORANGE(UNII: 5EVU04N5QU)
Product Characteristics
Color Score
Shape Size
Flavor ORANGE Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60505-0404-51 in 1 CARTON 10/08/2015
1150 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204094 10/08/2015

LABELER - Apotex Corp.(845263701)

REGISTRANT - Apotex Inc.(209429182)

PRINCIPAL DISPLAY PANEL

Bottle Label 

NDC 60505-0404-5 

Aripiprazole Oral Solution 1 mg/mL 

150 mL 

DISPENSE WITH MEDICATION GUIDE 

Rx only 

PRINCIPAL DISPLAY PANEL

Carton Label 

NDC 60505-0404-5 

Aripiprazole Oral Solution 1 mg/mL 

150 mL 

DISPENSE WITH MEDICATION GUIDE 

Rx only