NDC Code(s) : 66689-735-05
Packager : VistaPharm, Inc.

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:66689-735
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
EDETATE DISODIUM(UNII: 7FLD91C86K)
FRUCTOSE(UNII: 6YSS42VSEV)
GLYCERIN(UNII: PDC6A3C0OX)
MALIC ACID(UNII: 817L1N4CKP)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
WATER(UNII: 059QF0KO0R)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
SUCROSE(UNII: C151H8M554)
Product Characteristics
Color YELLOW (clear colorless to yellow) Score
Shape Size
Flavor ORANGE Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:66689-735-051 in 1 CARTON 19/06/2020
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 ANDA212870 06/19/2020

LABELER - VistaPharm, Inc.(116743084)

PRINCIPAL DISPLAY PANEL

NDC 66689-735-05

Aripiprazole
Oral Solution

1 mg per mL

PHARMACIST: Dispense the accompanying
Medication Guide to each patient.

150 mL

Rx Only

VistaPharm®

Aripiprazole Carton

PRINCIPAL DISPLAY PANEL

NDC 66689-735-05

Aripiprazole
Oral Solution

1 mg per mL

PHARMACIST: Dispense the accompanying
Medication Guide to each patient

150 mL

Rx Only

VistaPharm®

Aripiprazole Bottle Label