NDC Code(s) : 59148-018-71, 59148-019-71, 59148-019-91, 59148-045-80, 59148-072-80, 59148-072-92
Packager : Otsuka America Pharmaceutical, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ABILIFY MAINTENAaripiprazole KIT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59148-018
Route of Administration DEA Schedule
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED(UNII: K679OBS311)
MANNITOL(UNII: 3OWL53L36A)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE(UNII: 593YOG76RN)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59148-018-711 in 1 CARTON Type 0: Not a Combination Product28/09/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202971 02/28/2013
ABILIFY MAINTENAaripiprazole KIT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59148-019
Route of Administration DEA Schedule
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED(UNII: K679OBS311)
MANNITOL(UNII: 3OWL53L36A)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE(UNII: 593YOG76RN)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59148-019-711 in 1 CARTON Type 0: Not a Combination Product28/02/2013
2NDC:59148-019-911 in 1 CARTON Type 0: Not a Combination Product10/08/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202971 02/28/2013
ABILIFY MAINTENAaripiprazole KIT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59148-045
Route of Administration DEA Schedule
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED(UNII: K679OBS311)
MANNITOL(UNII: 3OWL53L36A)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE(UNII: 593YOG76RN)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59148-045-801 in 1 CARTON Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)10/08/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202971 10/08/2014
ABILIFY MAINTENAaripiprazole KIT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59148-072
Route of Administration DEA Schedule
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED(UNII: K679OBS311)
MANNITOL(UNII: 3OWL53L36A)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE(UNII: 593YOG76RN)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59148-072-801 in 1 CARTON Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)10/08/2014
2NDC:59148-072-921 in 1 CARTON Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)10/08/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202971 10/08/2014

LABELER - Otsuka America Pharmaceutical, Inc.(008314390)

PRINCIPAL DISPLAY PANEL

NDC 59148-018-70
Rx only
300 mg per vial

Abilify Maintena™ (aripiprazole)
for extended release injectable suspension
Single use only. Sterile. Discard any unused portion.
For deltoid or gluteal intramuscular injection only.
Usual Dosage: See package insert.

Manufactured by: Otsuka Pharmaceutical Co., Ltd.
Distributed and Marketed by: Otsuka America Pharmaceutical, Inc.
Marketed by: Lundbeck

PRINCIPAL DISPLAY PANEL - 300 mg Vial Label

PRINCIPAL DISPLAY PANEL

NDC 59148-100-01

5mL

Sterile Water
for Injection, USP
For single use only.

Discard unused portion.

Store at 25 °C (77 °F), excursions
permitted between 15 °C and 30 °C
(59 °F to 86 °F) [See USP].

09US12L-1008
Rx only

PRINCIPAL DISPLAY PANEL - 5 mL Vial Label

PRINCIPAL DISPLAY PANEL

NDC 59148-018-71
Rx only

Attention: Dispense an enclosed Medication Guide to each patient.

300 mg
per vial

Single use only. Discard Unused Portion.

For deltoid or gluteal
intramuscular injection only.

Abilify Maintena™
(aripiprazole) for extended release injectable suspension

Keep out of reach of children. Each injection must be administered by a healthcare professional only.

To reconstitute: Add 1.5 mL of Sterile Water for Injection, USP (supplied in kit) to make injectable suspension containing 200 mg/mL.

Excess water will be left in the vial; discard vial with the unused portion.

PRINCIPAL DISPLAY PANEL - 300 mg Kit Carton

PRINCIPAL DISPLAY PANEL

NDC 59148-019-70
Rx only
400 mg per vial

Abilify Maintena™ (aripiprazole)
for extended release injectable suspension
Single use only. Sterile. Discard any unused portion.
For deltoid or gluteal intramuscular injection only.
Usual Dosage: See package insert.

Manufactured by: Otsuka Pharmaceutical Co., Ltd.
Distributed and Marketed by: Otsuka America Pharmaceutical, Inc.
Marketed by: Lundbeck

PRINCIPAL DISPLAY PANEL - 400 mg Vial Label

PRINCIPAL DISPLAY PANEL

NDC 59148-019-71
Rx only

Attention: Dispense an enclosed Medication Guide to each patient.

400 mg
per vial

Single use only. Discard Unused Portion.

For deltoid or gluteal
intramuscular injection only.

Abilify Maintena™
(aripiprazole) for extended release injectable suspension

Keep out of reach of children. Each injection must be administered by a healthcare professional only.

To reconstitute: Add 1.9 mL of Sterile Water for Injection, USP (supplied in kit) to make injectable suspension containing 200 mg/mL.

Excess water will be left in the vial; discard vial with the unused portion.

PRINCIPAL DISPLAY PANEL - 400 mg Kit Carton

PRINCIPAL DISPLAY PANEL

NDC 59148-045-80

300 mg

Abilify Maintena®
(aripiprazole)
for extended release
injectable suspension
Single use only.
Sterile. Discard any
unused portion.
For deltoid or gluteal
intramuscular
injection only.
Usual Dosage:
See package insert.

516628AA

PRINCIPAL DISPLAY PANEL - 300 mg Syringe Label

PRINCIPAL DISPLAY PANEL

For deltoid or
gluteal intramuscular
injection only

NDC 59148-045-80

Abilify Maintena®
(aripiprazole) for extended release injectable suspension

300 mg PER PRE-FILLED
DUAL CHAMBER SYRINGE

Single use only.
Keep out of reach
of children.

Each injection must be administered by a healthcare professional only.
Attention: Dispense an enclosed Medication Guide to each patient.

Rx Only

PRINCIPAL DISPLAY PANEL - 300 mg Syringe Carton

PRINCIPAL DISPLAY PANEL

NDC 59148-072-80

400 mg

Abilify Maintena®
(aripiprazole)
for extended release
injectable suspension
Single use only.
Sterile. Discard any
unused portion.
For deltoid or gluteal
intramuscular
injection only.
Usual Dosage:
See package insert.

516629AA

PRINCIPAL DISPLAY PANEL - 400 mg Syringe Label

PRINCIPAL DISPLAY PANEL

For deltoid or
gluteal intramuscular
injection only

NDC 59148-072-80

Abilify Maintena®
(aripiprazole) for extended release injectable suspension

400 mg PER PRE-FILLED
DUAL CHAMBER SYRINGE

Single use only.
Keep out of reach
of children.

Each injection must be administered by a healthcare professional only.
Attention: Dispense an enclosed Medication Guide to each patient.

Rx Only

PRINCIPAL DISPLAY PANEL - 400 mg Syringe Carton