ABILIFY (Page 14 of 14)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

30 Tablets NDC 59148-006-13
ABILIFY®
(aripiprazole)
TABLETS
2 mg
DISPENSE WITH MEDICATION GUIDE
Rx only
Otsuka America Pharmaceutical, Inc.

Ablify 2 mg Tablets
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

30 Tablets NDC 59148-007-13
ABILIFY®
(aripiprazole)
TABLETS
5 mg
DISPENSE WITH MEDICATION GUIDE
Rx onlyOtsuka America Pharmaceutical, Inc.

Abilify 5 mg Tablets
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

30 Tablets NDC 59148-008-13
ABILIFY®
(aripiprazole)
TABLETS
10 mg
DISPENSE WITH MEDICATION GUIDE
Rx onlyOtsuka America Pharmaceutical, Inc.

Abilify 10 mg Tablets
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

30 Tablets NDC 59148-009-13
ABILIFY®
(aripiprazole)
TABLETS
15 mg
DISPENSE WITH MEDICATION GUIDE
Rx onlyOtsuka America Pharmaceutical, Inc.

Abilify 15 mg Tablets
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

30 Tablets NDC 59148-010-13
ABILIFY®
(aripiprazole)
TABLETS
20 mg
DISPENSE WITH MEDICATION GUIDE
Rx onlyOtsuka America Pharmaceutical, Inc.

Abilify 20 mg Tablets
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

30 Tablets NDC 59148-011-13
ABILIFY®
(aripiprazole)
TABLETS
30 mg
DISPENSE WITH MEDICATION GUIDE
Rx onlyOtsuka America Pharmaceutical, Inc.

Abilify 30 mg Tablets
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

1 Bottle NDC 59148-013-15
150 mL
ABILIFY®
(aripiprazole)
Oral Solution
1 mg/mL
DISPENSE WITH MEDICATION GUIDE
Rx only
Otsuka America Pharmaceutical, Inc. Bristol-Myers Squibb

ABILIFY Oral Solution 1mg/mL -- PDP
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

1 Vial NDC 59148-016-65
ABILIFY®
(aripiprazole)
INJECTION
9.75 mg/1.3 mL
(7.5 mg/mL)
DISPENSE WITH MEDICATION GUIDE
For Intramusular Use Only.
Single-use container.
Discard any unused portion.
Sterile, Ready-to-Use Solution.
Rx only
Otsuka America Pharmaceutical, Inc. Bristol-Myers Squibb

ABILIFY Injection FOR INTRAMUSCULAR USE ONLY -- PDP
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

30 Tablets (3 x 10) NDC 59148-640-23
ABILIFY DISCMELT®10 mg
(aripiprazole) Rx only
Orally Disintegrating Tablets
DISPENSE WITH MEDICATION GUIDE
Bristol-Myers Squibb
Otsuka America Pharmaceutical, Inc.

ABILIFY 10-mg Orally Disintegrating Tablets -- PDP
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

30 Tablets (3 x 10) NDC 59148-641-23
ABILIFY DISCMELT®15 mg
(aripiprazole) Rx only
Orally Disintegrating Tablets
DISPENSE WITH MEDICATION GUIDE
Bristol-Myers Squibb
Otsuka America Pharmaceutical, Inc.

ABILIFY 15-mg Orally Disintegrating Tablets -- PDP
(click image for full-size original)

ABILIFY aripiprazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59148-006
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARIPIPRAZOLE (ARIPIPRAZOLE) ARIPIPRAZOLE 2 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
FERRIC OXIDE YELLOW
FD&C BLUE NO. 2–ALUMINUM LAKE
Product Characteristics
Color green Score no score
Shape RECTANGLE (modified rectangle) Size 8mm
Flavor Imprint Code A;006;2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59148-006-13 30 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:59148-006-92 7 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021436 11/15/2002
ABILIFY aripiprazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59148-007
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARIPIPRAZOLE (ARIPIPRAZOLE) ARIPIPRAZOLE 5 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
FD&C BLUE NO. 2–ALUMINUM LAKE
Product Characteristics
Color blue Score no score
Shape RECTANGLE (modified rectangle) Size 8mm
Flavor Imprint Code A;007;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59148-007-13 30 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:59148-007-35 100 TABLET in 1 BLISTER PACK None
3 NDC:59148-007-94 7 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021436 11/15/2002
ABILIFY aripiprazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59148-008
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARIPIPRAZOLE (ARIPIPRAZOLE) ARIPIPRAZOLE 10 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
FERRIC OXIDE RED
Product Characteristics
Color pink Score no score
Shape RECTANGLE (modified rectangle) Size 8mm
Flavor Imprint Code A;008;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59148-008-13 30 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:59148-008-35 100 TABLET in 1 BLISTER PACK None
3 NDC:59148-008-95 7 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021436 11/15/2002
ABILIFY aripiprazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59148-009
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARIPIPRAZOLE (ARIPIPRAZOLE) ARIPIPRAZOLE 15 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
FERRIC OXIDE YELLOW
Product Characteristics
Color yellow Score no score
Shape ROUND Size 6mm
Flavor Imprint Code A;009;15
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59148-009-13 30 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:59148-009-35 100 TABLET in 1 BLISTER PACK None
3 NDC:59148-009-95 7 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021436 11/15/2002
ABILIFY aripiprazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59148-010
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARIPIPRAZOLE (ARIPIPRAZOLE) ARIPIPRAZOLE 20 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color white Score no score
Shape ROUND Size 8mm
Flavor Imprint Code A;010;20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59148-010-13 30 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:59148-010-35 100 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021436 11/15/2002
ABILIFY aripiprazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59148-011
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARIPIPRAZOLE (ARIPIPRAZOLE) ARIPIPRAZOLE 30 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
FERRIC OXIDE RED
Product Characteristics
Color pink Score no score
Shape ROUND Size 9mm
Flavor Imprint Code A;011;30
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59148-011-13 30 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:59148-011-35 100 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021436 11/15/2002
ABILIFY aripiprazole solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59148-013
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARIPIPRAZOLE (ARIPIPRAZOLE) ARIPIPRAZOLE 1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
FRUCTOSE 200 mg in 1 mL
GLYCERIN
LACTIC ACID, DL-
METHYLPARABEN
PROPYLENE GLYCOL
PROPYLPARABEN
SODIUM HYDROXIDE
SUCROSE 400 mg in 1 mL
WATER
Product Characteristics
Color Score
Shape Size
Flavor ORANGE (natural orange cream and other natural flavors) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59148-013-15 150 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021713 12/10/2004 04/15/2021
ABILIFY aripiprazole tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59148-640
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARIPIPRAZOLE (ARIPIPRAZOLE) ARIPIPRAZOLE 10 mg
Inactive Ingredients
Ingredient Name Strength
ACESULFAME POTASSIUM
ASPARTAME
CALCIUM SILICATE
CROSCARMELLOSE SODIUM
CROSPOVIDONE (120 .MU.M)
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
TARTARIC ACID
XYLITOL
FD&C BLUE NO. 2
ALUMINUM OXIDE
PHENYLALANINE 1.12 mg
Product Characteristics
Color pink (pink with scattered specks) Score no score
Shape ROUND Size 7mm
Flavor VANILLA (crème de vanilla (natural and artificial flavors)) Imprint Code A;640;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59148-640-23 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021729 06/07/2006 04/15/2021
ABILIFY aripiprazole tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59148-641
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARIPIPRAZOLE (ARIPIPRAZOLE) ARIPIPRAZOLE 15 mg
Inactive Ingredients
Ingredient Name Strength
ACESULFAME POTASSIUM
ASPARTAME
CALCIUM SILICATE
CROSCARMELLOSE SODIUM
CROSPOVIDONE (120 .MU.M)
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
TARTARIC ACID
XYLITOL
FD&C BLUE NO. 2
ALUMINUM OXIDE
PHENYLALANINE 1.68 mg
Product Characteristics
Color yellow (yellow with scattered specks) Score no score
Shape ROUND Size 8mm
Flavor VANILLA (crème de vanilla (natural and artificial flavors)) Imprint Code A;641;15
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59148-641-23 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021729 06/07/2006 04/15/2021
ABILIFY aripiprazole injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59148-016
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARIPIPRAZOLE (ARIPIPRAZOLE) ARIPIPRAZOLE 9.75 mg in 1.3 mL
Inactive Ingredients
Ingredient Name Strength
BETADEX SULFOBUTYL ETHER SODIUM
TARTARIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59148-016-65 1.3 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021866 09/20/2006 04/15/2021
Labeler — Otsuka America Pharmaceutical, Inc. (008314390)

Revised: 11/2022 Otsuka America Pharmaceutical, Inc.

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