Aripiprazole (Page 12 of 12)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 30 mg Blister Carton (10 x 10) Unit-dose Tablets

NDC 65862-666-78 Rx only

Aripiprazole Tablets USP

30 mg

PHARMACIST: Dispense the Medication Guide provided separately to each patient.

AUROBINDO 100 (10 x 10) Unit-dose Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 30 mg Blister Carton (10 x 10) Unit-dose Tablets
(click image for full-size original)
ARIPIPRAZOLE aripiprazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-661
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
SILICON DIOXIDE
STARCH, CORN
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
FD&C BLUE NO. 2
FERRIC OXIDE YELLOW
Product Characteristics
Color GREEN Score no score
Shape RECTANGLE Size 8mm
Flavor Imprint Code 61;H
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-661-30 30 TABLET in 1 BOTTLE None
2 NDC:65862-661-01 100 TABLET in 1 BOTTLE None
3 NDC:65862-661-05 500 TABLET in 1 BOTTLE None
4 NDC:65862-661-78 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (65862-661-10)
4 NDC:65862-661-10 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (65862-661-78)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203908 10/08/2015
ARIPIPRAZOLE aripiprazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-662
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
SILICON DIOXIDE
STARCH, CORN
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
FD&C BLUE NO. 2
Product Characteristics
Color BLUE Score no score
Shape RECTANGLE Size 8mm
Flavor Imprint Code 62;H
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-662-30 30 TABLET in 1 BOTTLE None
2 NDC:65862-662-01 100 TABLET in 1 BOTTLE None
3 NDC:65862-662-05 500 TABLET in 1 BOTTLE None
4 NDC:65862-662-78 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (65862-662-10)
4 NDC:65862-662-10 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (65862-662-78)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203908 10/08/2015
ARIPIPRAZOLE aripiprazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-663
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
SILICON DIOXIDE
STARCH, CORN
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color WHITE Score no score
Shape RECTANGLE Size 8mm
Flavor Imprint Code 63;H
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-663-30 30 TABLET in 1 BOTTLE None
2 NDC:65862-663-01 100 TABLET in 1 BOTTLE None
3 NDC:65862-663-05 500 TABLET in 1 BOTTLE None
4 NDC:65862-663-78 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (65862-663-10)
4 NDC:65862-663-10 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (65862-663-78)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203908 10/08/2015
ARIPIPRAZOLE aripiprazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-664
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
SILICON DIOXIDE
STARCH, CORN
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 7mm
Flavor Imprint Code 64;H
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-664-30 30 TABLET in 1 BOTTLE None
2 NDC:65862-664-01 100 TABLET in 1 BOTTLE None
3 NDC:65862-664-05 500 TABLET in 1 BOTTLE None
4 NDC:65862-664-78 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (65862-664-10)
4 NDC:65862-664-10 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (65862-664-78)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203908 10/08/2015
ARIPIPRAZOLE aripiprazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-665
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
SILICON DIOXIDE
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 65;H
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-665-30 30 TABLET in 1 BOTTLE None
2 NDC:65862-665-01 100 TABLET in 1 BOTTLE None
3 NDC:65862-665-05 500 TABLET in 1 BOTTLE None
4 NDC:65862-665-78 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (65862-665-10)
4 NDC:65862-665-10 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (65862-665-78)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203908 10/08/2015
ARIPIPRAZOLE aripiprazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-666
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
SILICON DIOXIDE
STARCH, CORN
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 9mm
Flavor Imprint Code 66;H
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-666-30 30 TABLET in 1 BOTTLE None
2 NDC:65862-666-01 100 TABLET in 1 BOTTLE None
3 NDC:65862-666-05 500 TABLET in 1 BOTTLE None
4 NDC:65862-666-78 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (65862-666-10)
4 NDC:65862-666-10 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (65862-666-78)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203908 10/08/2015
Labeler — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 650381903 ANALYSIS (65862-661), ANALYSIS (65862-662), ANALYSIS (65862-663), ANALYSIS (65862-664), ANALYSIS (65862-665), ANALYSIS (65862-666), MANUFACTURE (65862-661), MANUFACTURE (65862-662), MANUFACTURE (65862-663), MANUFACTURE (65862-664), MANUFACTURE (65862-665), MANUFACTURE (65862-666)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 650918514 ANALYSIS (65862-661), ANALYSIS (65862-662), ANALYSIS (65862-663), ANALYSIS (65862-664), ANALYSIS (65862-665), ANALYSIS (65862-666), MANUFACTURE (65862-661), MANUFACTURE (65862-662), MANUFACTURE (65862-663), MANUFACTURE (65862-664), MANUFACTURE (65862-665), MANUFACTURE (65862-666)

Revised: 02/2020 Aurobindo Pharma Limited

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