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
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65757-401
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
aripiprazole lauroxil(UNII: B786J7A343)
(aripiprazole lauroxil - UNII:B786J7A343) 		aripiprazole lauroxil441 mg in 1.6 mL
Inactive Ingredients
Ingredient Name Strength
Sorbitan Monolaurate(UNII: 6W9PS8B71J)
Polysorbate 20(UNII: 7T1F30V5YH)
Sodium Chloride(UNII: 451W47IQ8X)
Sodium Phosphate, Dibasic, Anhydrous(UNII: 22ADO53M6F)
Sodium Phosphate, Monobasic, Dihydrate(UNII: 5QWK665956)
Water(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65757-401-031 in 1 CARTON 10/05/2015
11.6 mL in 1 SYRINGE Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207533 10/05/2015
ARISTADAaripiprazole lauroxil INJECTION, SUSPENSION, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65757-402
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
aripiprazole lauroxil(UNII: B786J7A343)
(aripiprazole lauroxil - UNII:B786J7A343) 		aripiprazole lauroxil662 mg in 2.4 mL
Inactive Ingredients
Ingredient Name Strength
Sorbitan Monolaurate(UNII: 6W9PS8B71J)
Polysorbate 20(UNII: 7T1F30V5YH)
Sodium Chloride(UNII: 451W47IQ8X)
Sodium Phosphate, Dibasic, Anhydrous(UNII: 22ADO53M6F)
Sodium Phosphate, Monobasic, Dihydrate(UNII: 5QWK665956)
Water(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65757-402-031 in 1 CARTON 10/05/2015
12.4 mL in 1 SYRINGE Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207533 10/05/2015
ARISTADAaripiprazole lauroxil INJECTION, SUSPENSION, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65757-403
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
aripiprazole lauroxil(UNII: B786J7A343)
(aripiprazole lauroxil - UNII:B786J7A343) 		aripiprazole lauroxil882 mg in 3.2 mL
Inactive Ingredients
Ingredient Name Strength
Sorbitan Monolaurate(UNII: 6W9PS8B71J)
Polysorbate 20(UNII: 7T1F30V5YH)
Sodium Chloride(UNII: 451W47IQ8X)
Sodium Phosphate, Dibasic, Anhydrous(UNII: 22ADO53M6F)
Sodium Phosphate, Monobasic, Dihydrate(UNII: 5QWK665956)
Water(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65757-403-031 in 1 CARTON 10/05/2015
13.2 mL in 1 SYRINGE Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207533 10/05/2015
ARISTADAaripiprazole lauroxil INJECTION, SUSPENSION, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65757-404
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
aripiprazole lauroxil(UNII: B786J7A343)
(aripiprazole lauroxil - UNII:B786J7A343) 		aripiprazole lauroxil1064 mg in 3.9 mL
Inactive Ingredients
Ingredient Name Strength
Sorbitan Monolaurate(UNII: 6W9PS8B71J)
Polysorbate 20(UNII: 7T1F30V5YH)
Sodium Chloride(UNII: 451W47IQ8X)
Sodium Phosphate, Dibasic, Anhydrous(UNII: 22ADO53M6F)
Sodium Phosphate, Monobasic, Dihydrate(UNII: 5QWK665956)
Water(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65757-404-031 in 1 CARTON 06/05/2017
13.9 mL in 1 SYRINGE Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207533 06/05/2017

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 - 441 mg/1.6 mL Carton Label

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 - 662 mg/2.4 mL Carton Label

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 - 882 mg/3.2 mL Carton Label

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

Principal Display Panel - 1064 mg/3.9 mL Carton Label