NDC Code(s) : 65757-401-03, 65757-402-03, 65757-403-03, 65757-404-03
Packager : Alkermes, Inc.
Category : HUMAN PRESCRIPTION DRUG LABEL
DEA Schedule : none
Marketing Status : New Drug Application
INGREDIENTS AND APPEARANCE
ARISTADAaripiprazole lauroxil INJECTION, SUSPENSION, EXTENDED RELEASE | ||||||||||||||||||||
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ARISTADAaripiprazole lauroxil INJECTION, SUSPENSION, EXTENDED RELEASE | ||||||||||||||||||||
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LABELER - Alkermes, Inc.(185481132) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
Alkermes, Inc | 858582083 | MANUFACTURE(65757-401, 65757-402, 65757-403, 65757-404), ANALYSIS(65757-401, 65757-402, 65757-403, 65757-404) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
Sharp Corporation | 143696495 | LABEL(65757-401, 65757-402, 65757-403, 65757-404), PACK(65757-401, 65757-402, 65757-403, 65757-404) |
PRINCIPAL DISPLAY PANEL
Principal Display Panel - 441 mg/1.6 mL Carton Label
NDC: 65757-401-03
Rx only
Aristada
®
aripiprazole lauroxil
extended-release injectable suspension
441 mg
For deltoid or gluteal intramuscular injection only
Single-dose injection - Entire Content of Syringe Must Be
Administered by Healthcare Professional Only
441 mg/1.6 mL administered monthly.
For dosing and administration instructions, please
see accompanying full prescribing information.
Dispense enclosed Medication Guide to Patient.
Store at room temperature 20°C to 25°C (68°F to 77°F)
with excursions permitted between 15°C to 30°C (59°F to 86°F)
Keep out of reach of children
PRINCIPAL DISPLAY PANEL
Principal Display Panel - 662 mg/2.4 mL Carton Label
NDC: 65757-402-03
Rx only
Aristada
®
aripiprazole lauroxil
extended-release injectable suspension
662 mg
For gluteal intramuscular injection only
Single-dose injection - Entire Content of Syringe Must Be
Administered by Healthcare Professional Only
662 mg/2.4 mL administered monthly.
For dosing and administration instructions, please
see accompanying full prescribing information.
Dispense enclosed Medication Guide to Patient.
Store at room temperature 20°C to 25°C (68°F to 77°F)
with excursions permitted between 15°C to 30°C (59°F to 86°F)
Keep out of reach of children
PRINCIPAL DISPLAY PANEL
Principal Display Panel - 882 mg/3.2 mL Carton Label
NDC: 65757-403-03
Rx only
Aristada
®
aripiprazole lauroxil
extended-release injectable suspension
882 mg
For gluteal intramuscular injection only
Single-dose injection - Entire Content of Syringe Must Be
Administered by Healthcare Professional Only
882 mg/3.2 mL administered monthly or every 6 weeks.
For dosing and administration instructions, please
see accompanying full prescribing information.
Dispense enclosed Medication Guide to Patient.
Store at room temperature 20°C to 25°C (68°F to 77°F)
with excursions permitted between 15°C to 30°C (59°F to 86°F)
Keep out of reach of children
PRINCIPAL DISPLAY PANEL
Principal Display Panel - 1064 mg/3.9 mL Carton Label
NDC: 65757-404-03
Rx only
Aristada
®
aripiprazole lauroxil
extended-release injectable suspension
1064 mg
For gluteal intramuscular injection only
Single-dose injection - Entire Content of Syringe Must Be
Administered by Healthcare Professional Only
1064 mg/3.9 mL administered every 2 months.
For dosing and administration instructions, please
see accompanying full prescribing information.
Dispense enclosed Medication Guide to Patient.
Store at room temperature 20°C to 25°C (68°F to 77°F)
with excursions permitted between 15°C to 30°C (59°F to 86°F)
Keep out of reach of children