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ARISTADA INITIO

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

Approved
Approval ID

b18fdfd9-31cd-4a2f-9f1c-ebc70d7a9403

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 1, 2023

Manufacturers
FDA

Alkermes, Inc.

DUNS: 185481132

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

aripiprazole lauroxil

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code65757-500
Application NumberNDA209830
Product Classification
M
Marketing Category
C73594
G
Generic Name
aripiprazole lauroxil
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateJanuary 15, 2021
FDA Product Classification

INGREDIENTS (7)

aripiprazole lauroxilActive
Quantity: 675 mg in 2.4 mL
Code: B786J7A343
Classification: ACTIB
Trisodium Citrate DihydrateInactive
Code: B22547B95K
Classification: IACT
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT
Polysorbate 20Inactive
Code: 7T1F30V5YH
Classification: IACT
Sodium Phosphate, Dibasic, AnhydrousInactive
Code: 22ADO53M6F
Classification: IACT
Sodium Phosphate, Monobasic, DihydrateInactive
Code: 5QWK665956
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT

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ARISTADA INITIO - FDA Drug Approval Details