Aripiprazole: Package Insert and Label Information (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

150 ml carton
(click image for full-size original)
150 ml bottle label
(click image for full-size original)
ARIPIPRAZOLE aripiprazole solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54838-570
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARIPIPRAZOLE (ARIPIPRAZOLE) ARIPIPRAZOLE 1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYANISOLE
METHYLPARABEN
PHOSPHORIC ACID
PROPYLENE GLYCOL
PROPYLPARABEN
SODIUM HYDROXIDE
SUCRALOSE
WATER
Product Characteristics
Color Score
Shape Size
Flavor ORANGE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54838-570-59 150 mL in 1 BOTTLE, PLASTIC None
2 NDC:54838-570-70 237 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204171 08/17/2015
Labeler — Lannett Company, Inc. (161630033)

Revised: 01/2020 Lannett Company, Inc.

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.