Aripiprazole (Page 15 of 15)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aripiprazole tablets, USP 2 mg

2 mg
(click image for full-size original)

Aripiprazole tablets, USP 5 mg

5 mg
(click image for full-size original)

Aripiprazole tablets, USP 10 mg

10 mg
(click image for full-size original)

Aripiprazole tablets, USP 15 mg

15 mg
(click image for full-size original)

Aripiprazole tablets, USP 20 mg

20 mg
(click image for full-size original)

Aripiprazole tablets, USP 30 mg

30 mg
(click image for full-size original)
ARIPIPRAZOLE aripiprazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-216
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
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE, UNSPECIFIED
FERRIC OXIDE YELLOW
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
MAGNESIUM STEARATE
MANNITOL
SILICON DIOXIDE
Product Characteristics
Color yellow Score no score
Shape ROUND Size 5mm
Flavor Imprint Code 2;16
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-216-69 6250 TABLET in 1 BOTTLE None
2 NDC:13668-216-01 100 TABLET in 1 BOTTLE None
3 NDC:13668-216-90 90 TABLET in 1 BOTTLE None
4 NDC:13668-216-05 500 TABLET in 1 BOTTLE None
5 NDC:13668-216-30 30 TABLET in 1 BOTTLE None
6 NDC:13668-216-74 100 TABLET in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201519 04/28/2015
ARIPIPRAZOLE aripiprazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-217
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
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE, UNSPECIFIED
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
MAGNESIUM STEARATE
MANNITOL
SILICON DIOXIDE
Product Characteristics
Color white (white to off-white) Score no score
Shape ROUND Size 5mm
Flavor Imprint Code 5;17
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-217-69 6250 TABLET in 1 BOTTLE None
2 NDC:13668-217-05 500 TABLET in 1 BOTTLE None
3 NDC:13668-217-01 100 TABLET in 1 BOTTLE None
4 NDC:13668-217-90 90 TABLET in 1 BOTTLE None
5 NDC:13668-217-30 30 TABLET in 1 BOTTLE None
6 NDC:13668-217-74 100 TABLET in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201519 04/28/2015
ARIPIPRAZOLE aripiprazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-218
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
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE, UNSPECIFIED
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
MAGNESIUM STEARATE
MANNITOL
SILICON DIOXIDE
Product Characteristics
Color white (white to off-white) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code 10;18
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-218-05 500 TABLET in 1 BOTTLE None
2 NDC:13668-218-90 90 TABLET in 1 BOTTLE None
3 NDC:13668-218-30 30 TABLET in 1 BOTTLE None
4 NDC:13668-218-01 100 TABLET in 1 BOTTLE None
5 NDC:13668-218-52 7000 TABLET in 1 BOTTLE None
6 NDC:13668-218-74 100 TABLET in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201519 04/28/2015
ARIPIPRAZOLE aripiprazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-219
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
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE, UNSPECIFIED
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
MAGNESIUM STEARATE
MANNITOL
SILICON DIOXIDE
Product Characteristics
Color white (white to off-white) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 15;19
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-219-90 90 TABLET in 1 BOTTLE None
2 NDC:13668-219-05 500 TABLET in 1 BOTTLE None
3 NDC:13668-219-30 30 TABLET in 1 BOTTLE None
4 NDC:13668-219-01 100 TABLET in 1 BOTTLE None
5 NDC:13668-219-51 5000 TABLET in 1 BOTTLE None
6 NDC:13668-219-74 100 TABLET in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201519 04/28/2015
ARIPIPRAZOLE aripiprazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-220
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
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE, UNSPECIFIED
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
MAGNESIUM STEARATE
MANNITOL
SILICON DIOXIDE
Product Characteristics
Color white (white to off-white) Score no score
Shape ROUND Size 9mm
Flavor Imprint Code 20;20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-220-68 3400 TABLET in 1 BOTTLE None
2 NDC:13668-220-30 30 TABLET in 1 BOTTLE None
3 NDC:13668-220-90 90 TABLET in 1 BOTTLE None
4 NDC:13668-220-01 100 TABLET in 1 BOTTLE None
5 NDC:13668-220-05 500 TABLET in 1 BOTTLE None
6 NDC:13668-220-74 100 TABLET in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201519 04/28/2015
ARIPIPRAZOLE aripiprazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-221
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
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE, UNSPECIFIED
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
MAGNESIUM STEARATE
MANNITOL
SILICON DIOXIDE
Product Characteristics
Color white (white to off-white) Score no score
Shape ROUND Size 10mm
Flavor Imprint Code 30;21
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-221-30 30 TABLET in 1 BOTTLE None
2 NDC:13668-221-90 90 TABLET in 1 BOTTLE None
3 NDC:13668-221-01 100 TABLET in 1 BOTTLE None
4 NDC:13668-221-05 500 TABLET in 1 BOTTLE None
5 NDC:13668-221-31 2500 TABLET in 1 BOTTLE None
6 NDC:13668-221-74 100 TABLET in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201519 04/28/2015
Labeler — Torrent Pharmaceuticals Limited (916488547)
Registrant — Torrent Pharma, Inc. (790033935)
Establishment
Name Address ID/FEI Operations
Torrent Pharmaceuticals Limited 916488547 manufacture (13668-216), manufacture (13668-217), manufacture (13668-218), manufacture (13668-219), manufacture (13668-220), manufacture (13668-221)

Revised: 07/2020 Torrent Pharmaceuticals Limited

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