ARIPIPRAZOLE (Page 14 of 14)

PRINCIPAL DISPLAY PANEL

NDC 16729- 278 -10

Aripiprazole Tablets, USP

2 mg-30 Tablets

PHARMACIST: Dispense the enclosed Medication Guide to each patient.

Rx Only

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

NDC 16729- 278 -46

Aripiprazole Tablets, USP

2 mg-100 (10 x 10) Unit-dose Tablets

PHARMACIST: Dispense the enclosed Medication Guide to each patient.

Rx Only

2 mg-100 (10 x 10) Unit-dose Tablets
(click image for full-size original)

NDC 16729- 279 -10

Aripiprazole Tablets, USP

5 mg-30 Tablets

PHARMACIST: Dispense the enclosed Medication Guide to each patient.

Rx Only

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

NDC 16729- 279 -46

Aripiprazole Tablets, USP

5 mg-100 (10 x 10) Unit-dose Tablets

PHARMACIST: Dispense the enclosed Medication Guide to each patient.

Rx Only

5 mg-100 (10 x 10) Unit-dose Tablets
(click image for full-size original)

NDC 16729- 280 -10

Aripiprazole Tablets, USP

10 mg-30 Tablets

PHARMACIST: Dispense the enclosed Medication Guide to each patient.

Rx Only

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

NDC 16729- 280 -46

Aripiprazole Tablets, USP

10 mg-100 (10 x 10) Unit-dose Tablets

PHARMACIST: Dispense the enclosed Medication Guide to each patient.

Rx Only

10 mg-100 (10 x 10) Unit-dose Tablets
(click image for full-size original)

NDC 16729- 281 -10

Aripiprazole Tablets, USP

15 mg-30 Tablets

PHARMACIST: Dispense the enclosed Medication Guide to each patient.

Rx Only

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

NDC 16729- 281 -46

Aripiprazole Tablets, USP

15 mg-100 (10 x 10) Unit-dose Tablets

PHARMACIST: Dispense the enclosed Medication Guide to each patient.

Rx Only

15 mg-100 (10 x 10) Unit-dose Tablets
(click image for full-size original)

NDC 16729- 282 -10

Aripiprazole Tablets, USP

20 mg-30 Tablets

PHARMACIST: Dispense the enclosed Medication Guide to each patient.

Rx Only

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

NDC 16729- 282 -46

Aripiprazole Tablets, USP

20 mg-100 (10 x 10) Unit-dose Tablets

PHARMACIST: Dispense the enclosed Medication Guide to each patient.

Rx Only

20 mg-100 (10 x 10) Unit-dose Tablets
(click image for full-size original)

NDC 16729- 283 -10

Aripiprazole Tablets, USP

30 mg-30 Tablets

PHARMACIST: Dispense the enclosed Medication Guide to each patient.

Rx Only

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

NDC 16729- 283 -46

Aripiprazole Tablets, USP

30 mg-100 (10 x 10) Unit-dose Tablets

PHARMACIST: Dispense the enclosed Medication Guide to each patient.

Rx Only

30 mg-100 (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:16729-278
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 (TYPE L)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
FERRIC OXIDE YELLOW
FD&C BLUE NO. 2
ALUMINUM OXIDE
Product Characteristics
Color green Score no score
Shape RECTANGLE (modified rectangle) Size 8mm
Flavor Imprint Code A2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16729-278-10 30 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:16729-278-01 100 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:16729-278-16 500 TABLET in 1 BOTTLE, PLASTIC None
4 NDC:16729-278-46 100 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206251 02/15/2017
ARIPIPRAZOLE aripiprazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-279
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 (TYPE L)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
FD&C BLUE NO. 2
Product Characteristics
Color blue Score no score
Shape RECTANGLE (modified rectangle) Size 8mm
Flavor Imprint Code A5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16729-279-10 30 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:16729-279-01 100 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:16729-279-16 500 TABLET in 1 BOTTLE, PLASTIC None
4 NDC:16729-279-46 100 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206251 02/15/2017
ARIPIPRAZOLE aripiprazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-280
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 (TYPE L)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
FERRIC OXIDE RED
Product Characteristics
Color pink Score no score
Shape RECTANGLE (modified rectangle) Size 8mm
Flavor Imprint Code A10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16729-280-10 30 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:16729-280-01 100 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:16729-280-16 500 TABLET in 1 BOTTLE, PLASTIC None
4 NDC:16729-280-46 100 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206251 02/15/2017
ARIPIPRAZOLE aripiprazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-281
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 (TYPE L)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
FERRIC OXIDE YELLOW
Product Characteristics
Color yellow Score no score
Shape ROUND Size 7mm
Flavor Imprint Code A15
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16729-281-10 30 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:16729-281-01 100 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:16729-281-16 500 TABLET in 1 BOTTLE, PLASTIC None
4 NDC:16729-281-46 100 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206251 02/15/2017
ARIPIPRAZOLE aripiprazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-282
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 (TYPE L)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color white (white to off white) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code A20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16729-282-10 30 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:16729-282-01 100 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:16729-282-16 500 TABLET in 1 BOTTLE, PLASTIC None
4 NDC:16729-282-46 100 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206251 02/15/2017
ARIPIPRAZOLE aripiprazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-283
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 (TYPE L)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
FERRIC OXIDE RED
Product Characteristics
Color pink Score no score
Shape ROUND Size 9mm
Flavor Imprint Code A30
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16729-283-10 30 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:16729-283-01 100 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:16729-283-16 500 TABLET in 1 BOTTLE, PLASTIC None
4 NDC:16729-283-46 100 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206251 02/14/2017
Labeler — Accord Healthcare, Inc. (604222237)
Establishment
Name Address ID/FEI Operations
Intas Pharmaceuticals Limited 915837971 manufacture (16729-278), manufacture (16729-279), manufacture (16729-280), manufacture (16729-281), manufacture (16729-282), manufacture (16729-283)

Revised: 05/2020 Accord Healthcare, Inc.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.