DrugCite

ABILIFY MAINTENA KIT - aripiprazole injection, powder, lyophilized, for suspension, extended release 
Otsuka America Pharmaceutical, Inc.

ARIPIPRAZOLE MAINTENA Labeling

ABILIFY MAINTENA KIT


Aripiprazole for extended release injectable suspension 300mg per vial

Label of kit for 300 mg per vials

Image of 300-mg kit label

ARIPIPRAZOLE MAINTENA KIT

Aripiprazole for extended release injectable suspension 400mg per vial

Label of kit for 400 mg per vials

Image of 400-mg kit label


ABILIFY MAINTENA KIT 
aripiprazole  injection, powder, lyophilized, for suspension, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 59148-018
Route of Administration INTRAMUSCULAR DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARIPIPRAZOLE (ARIPIPRAZOLE) ARIPIPRAZOLE 300 mg  in 1.5 mL
Inactive Ingredients
Ingredient Name Strength
No Inactive Ingredients Found
Product Characteristics
Color white (White to off-white) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 59148-018-71 1 VIAL In 1 KIT contains a VIAL
1 1.5 mL In 1 VIAL This package is contained within the KIT (59148-018-71)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202971 04/02/2023

ABILIFY MAINTENA KIT 
aripiprazole  injection, powder, lyophilized, for suspension, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 59148-019
Route of Administration INTRAMUSCULAR DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARIPIPRAZOLE (ARIPIPRAZOLE) ARIPIPRAZOLE 400 mg  in 2.0 mL
Inactive Ingredients
Ingredient Name Strength
No Inactive Ingredients Found
Product Characteristics
Color white (White to off-white) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 59148-019-71 1 VIAL In 1 KIT contains a VIAL
1 2.0 mL In 1 VIAL This package is contained within the KIT (59148-019-71)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202971 09/01/2023

Labeler - Otsuka America Pharmaceutical, Inc. (008314390)
Revised: 04/2013Otsuka America Pharmaceutical, Inc.