Aripiprazole (Page 11 of 11)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rx only
Aripiprazole Tablets, USP 2 mg
NDC: 16714-783-01 30′s Tablets

2mg-30s
(click image for full-size original)

Rx only
Aripiprazole Tablets, USP 5 mg
NDC:16714-784-01 30′s Tablets

5mg-30s
(click image for full-size original)

Rx only
Aripiprazole Tablets, USP 10 mg
NDC:16714-785-01 30′s Tablets

10mg-30s
(click image for full-size original)

Rx only
Aripiprazole Tablets, USP 15 mg
NDC:16714-786-01 30′s Tablets

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

Rx only
Aripiprazole Tablets, USP 20 mg
NDC:16714-787-01 30′s Tablets

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

Rx only
Aripiprazole Tablets, USP 30 mg
NDC:16714-788-01 30′s Tablets

30mg-30s
(click image for full-size original)
ARIPIPRAZOLE aripiprazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-783
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
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
FERRIC OXIDE YELLOW
FD&C BLUE NO. 2
Product Characteristics
Color GREEN (green) Score no score
Shape RECTANGLE (modified rectangle shape) Size 8mm
Flavor Imprint Code CL;72
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-783-01 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204111 03/07/2018
ARIPIPRAZOLE aripiprazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-784
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
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
FD&C BLUE NO. 2
Product Characteristics
Color BLUE (Blue) Score no score
Shape RECTANGLE (modified rectangle shape) Size 8mm
Flavor Imprint Code CL;73
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-784-01 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204111 03/07/2018
ARIPIPRAZOLE aripiprazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-785
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
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
FERRIC OXIDE RED
Product Characteristics
Color PINK (pink) Score no score
Shape RECTANGLE (modified rectangle shape) Size 8mm
Flavor Imprint Code CL;74
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-785-01 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204111 03/07/2018
ARIPIPRAZOLE aripiprazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-786
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
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW (yellow) Score no score
Shape ROUND (round shaped) Size 7mm
Flavor Imprint Code CL;75
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-786-01 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204111 03/07/2018
ARIPIPRAZOLE aripiprazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-787
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
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color WHITE (White to off- white) Score no score
Shape ROUND (round shaped) Size 8mm
Flavor Imprint Code CL;76
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-787-01 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204111 03/07/2018
ARIPIPRAZOLE aripiprazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-788
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
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
FERRIC OXIDE RED
Product Characteristics
Color PINK (Pink) Score no score
Shape ROUND (round shaped) Size 9mm
Flavor Imprint Code CL;78
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-788-01 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204111 03/07/2018
Labeler — NorthStar RxLLC (830546433)
Establishment
Name Address ID/FEI Operations
Macleods Pharmaceuticals Limited 676369519 ANALYSIS (16714-783), ANALYSIS (16714-784), ANALYSIS (16714-785), ANALYSIS (16714-786), ANALYSIS (16714-787), ANALYSIS (16714-788), LABEL (16714-783), LABEL (16714-784), LABEL (16714-785), LABEL (16714-786), LABEL (16714-787), LABEL (16714-788), MANUFACTURE (16714-783), MANUFACTURE (16714-784), MANUFACTURE (16714-785), MANUFACTURE (16714-786), MANUFACTURE (16714-787), MANUFACTURE (16714-788), PACK (16714-783), PACK (16714-784), PACK (16714-785), PACK (16714-786), PACK (16714-787), PACK (16714-788)

Revised: 09/2019 NorthStar RxLLC

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