ARISTADA

Basic Information

Product Name

ARISTADA

FDA Product Code

65757-404

Regulatory Information

NDC Product Code

65757-404

Application Number

NDA207533

Marketing Category

C73594

Effective Date

January 15, 2021

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use ARISTADA safely and effectively. See full prescribing information for ARISTADA. ARISTADA (aripiprazole lauroxil) extended-release injectable suspension, for intramuscular useInitial U.S. Approval: 2015

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

aripiprazole lauroxil

Quantity: 1064 mg in 3.9 mL

Code: B786J7A343

Class Code: ACTIB

Sorbitan Monolaurate

Code: 6W9PS8B71J

Class Code: IACT

Polysorbate 20

Code: 7T1F30V5YH

Class Code: IACT

Sodium Phosphate, Dibasic, Anhydrous

Code: 22ADO53M6F

Class Code: IACT

Sodium Chloride

Code: 451W47IQ8X

Class Code: IACT

Sodium Phosphate, Monobasic, Dihydrate

Code: 5QWK665956

Class Code: IACT

Water

Code: 059QF0KO0R

Class Code: IACT

Active Moieties

aripiprazole lauroxil

Code: B786J7A343

Basic Information

Regulatory Information

Company Information

Active Ingredients

Sorbitan Monolaurate

Polysorbate 20

Sodium Phosphate, Dibasic, Anhydrous

Sodium Chloride

Sodium Phosphate, Monobasic, Dihydrate

Water

Active Moieties

aripiprazole lauroxil