Aripiprazole (Page 12 of 12)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2 mg 30s count

2mg3oscount
(click image for full-size original)

5mg3oscount
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10 mg 30s count

10mg3oscount
(click image for full-size original)

15 mg 30s count
15mg3oscount
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20 mg 30s count
20mg3oscount
(click image for full-size original)

30 mg 30s count

30mg3oscount
(click image for full-size original)

ARIPIPRAZOLE aripiprazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-141
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
FD&C BLUE NO. 2
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color GREEN Score no score
Shape RECTANGLE Size 8mm
Flavor Imprint Code I;94
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-141-01 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205064 10/01/2020
ARIPIPRAZOLE aripiprazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-142
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
FD&C BLUE NO. 2
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color BLUE Score no score
Shape RECTANGLE Size 8mm
Flavor Imprint Code I;95
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-142-01 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205064 10/01/2020
ARIPIPRAZOLE aripiprazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-143
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
FD&C BLUE NO. 2
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color PINK Score no score
Shape RECTANGLE Size 8mm
Flavor Imprint Code I;96
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-143-01 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205064 10/01/2020
ARIPIPRAZOLE aripiprazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-144
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
FD&C BLUE NO. 2
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 7mm
Flavor Imprint Code I;97
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-144-01 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205064 10/01/2020
ARIPIPRAZOLE aripiprazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-145
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
FD&C BLUE NO. 2
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color WHITE (off-white) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code I;98
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-145-01 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205064 10/01/2020
ARIPIPRAZOLE aripiprazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-146
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
FD&C BLUE NO. 2
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color PINK Score no score
Shape ROUND Size 9mm
Flavor Imprint Code I;99
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-146-01 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205064 10/01/2020
Labeler — NorthStar RxLLC (830546433)
Registrant — Hetero Labs Limited Unit V (650452530)
Establishment
Name Address ID/FEI Operations
Hetero Labs Limited Unit V 650452530 ANALYSIS (16714-141), ANALYSIS (16714-142), ANALYSIS (16714-143), ANALYSIS (16714-144), ANALYSIS (16714-145), ANALYSIS (16714-146), MANUFACTURE (16714-141), MANUFACTURE (16714-142), MANUFACTURE (16714-143), MANUFACTURE (16714-144), MANUFACTURE (16714-145), MANUFACTURE (16714-146)

Revised: 10/2020 NorthStar RxLLC

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