ARISTADA
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
Approved
Approval ID
17a8d11b-73b0-4833-a0b4-cf1ef85edefb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 2023
Manufacturers
FDA
Alkermes, Inc.
DUNS: 185481132
Products 4
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 Code65757-404
Application NumberNDA207533
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: 1064 mg in 3.9 mL
Code: B786J7A343
Classification: ACTIB
Sorbitan MonolaurateInactive
Code: 6W9PS8B71J
Classification: IACT
Polysorbate 20Inactive
Code: 7T1F30V5YH
Classification: IACT
Sodium Phosphate, Dibasic, AnhydrousInactive
Code: 22ADO53M6F
Classification: IACT
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT
Sodium Phosphate, Monobasic, DihydrateInactive
Code: 5QWK665956
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
aripiprazole lauroxil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65757-402
Application NumberNDA207533
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: 662 mg in 2.4 mL
Code: B786J7A343
Classification: ACTIB
Polysorbate 20Inactive
Code: 7T1F30V5YH
Classification: IACT
Sodium Phosphate, Dibasic, AnhydrousInactive
Code: 22ADO53M6F
Classification: IACT
Sorbitan MonolaurateInactive
Code: 6W9PS8B71J
Classification: IACT
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT
Sodium Phosphate, Monobasic, DihydrateInactive
Code: 5QWK665956
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
aripiprazole lauroxil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65757-403
Application NumberNDA207533
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: 882 mg in 3.2 mL
Code: B786J7A343
Classification: ACTIB
Sorbitan MonolaurateInactive
Code: 6W9PS8B71J
Classification: IACT
Polysorbate 20Inactive
Code: 7T1F30V5YH
Classification: IACT
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT
Sodium Phosphate, Dibasic, AnhydrousInactive
Code: 22ADO53M6F
Classification: IACT
Sodium Phosphate, Monobasic, DihydrateInactive
Code: 5QWK665956
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
aripiprazole lauroxil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65757-401
Application NumberNDA207533
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)
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Sodium Phosphate, Monobasic, DihydrateInactive
Code: 5QWK665956
Classification: IACT
aripiprazole lauroxilActive
Quantity: 441 mg in 1.6 mL
Code: B786J7A343
Classification: ACTIB
Sorbitan MonolaurateInactive
Code: 6W9PS8B71J
Classification: IACT
Polysorbate 20Inactive
Code: 7T1F30V5YH
Classification: IACT
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT
Sodium Phosphate, Dibasic, AnhydrousInactive
Code: 22ADO53M6F
Classification: IACT