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Aripiprazole ODT

Package insert / prescribing information
Dosage form: tablet, orally disintegrating
Drug class: Atypical antipsychotics

Medically reviewed by Drugs.com. Last updated on Jun 1, 2022.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 76483-100-00

Aripiprazole Orally Disintegrating Tablets, USP 10 mg

30 Tablets

Rx Only

NDC 76483-100-01

Aripiprazole Orally Disintegrating Tablets, USP 10 mg

60 Tablets

Rx Only

NDC 76483-100-02

Aripiprazole Orally Disintegrating Tablets, USP 10 mg

90 Tablets

Rx Only

NDC 76483-100-03

Aripiprazole Orally Disintegrating Tablets, USP 10 mg

120 Tablets

Rx Only

NDC 76483-101-00

Aripiprazole Orally Disintegrating Tablets, USP 15 mg

30 Tablets

Rx Only

NDC 76483-101-01

Aripiprazole Orally Disintegrating Tablets, USP 15 mg

60 Tablets

Rx Only

NDC 76483-101-02

Aripiprazole Orally Disintegrating Tablets, USP 15 mg

90 Tablets

Rx Only

NDC 76483-101-03

Aripiprazole Orally Disintegrating Tablets, USP 15 mg

120 Tablets

Rx Only

NDC 76483-102-00

Aripiprazole Orally Disintegrating Tablets, USP 20 mg

30 Tablets

Rx Only

NDC 76483-102-01

Aripiprazole Orally Disintegrating Tablets, USP 20 mg

60 Tablets

Rx Only

NDC 76483-102-02

Aripiprazole Orally Disintegrating Tablets, USP 20 mg

90 Tablets

Rx Only

NDC 76483-102-03

Aripiprazole Orally Disintegrating Tablets, USP 20 mg

120 Tablets

Rx Only

NDC 76483-103-00

Aripiprazole Orally Disintegrating Tablets, USP 30 mg

30 Tablets

Rx Only

NDC 76483-103-01

Aripiprazole Orally Disintegrating Tablets, USP 30 mg

60 Tablets

Rx Only

NDC 76483-103-02

Aripiprazole Orally Disintegrating Tablets, USP 30 mg

90 Tablets

Rx Only

NDC 76483-103-03

Aripiprazole Orally Disintegrating Tablets, USP 30 mg

120 Tablets

Rx Only

ARIPIPRAZOLE
aripiprazole tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:76483-100
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
ASPARTAME
CALCIUM STEARATE
CROSPOVIDONE
PEPPERMINT
MANNITOL
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape CAPSULE Size 8mm
Flavor PEPPERMINT (FLAVOR FIRMENICH POWDER PEPPERMINT) Imprint Code ZF;41
Contains
Packaging
# Item Code Package Description
1 NDC:76483-100-00 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
2 NDC:76483-100-01 60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
3 NDC:76483-100-02 90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
4 NDC:76483-100-03 120 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090165 06/20/2022
ARIPIPRAZOLE
aripiprazole tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:76483-101
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
ASPARTAME
CALCIUM STEARATE
CROSPOVIDONE
PEPPERMINT
MANNITOL
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape ROUND Size 8mm
Flavor PEPPERMINT (FLAVOR FIRMENICH POWDER PEPPERMINT) Imprint Code ZF;42
Contains
Packaging
# Item Code Package Description
1 NDC:76483-101-00 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
2 NDC:76483-101-01 60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
3 NDC:76483-101-02 90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
4 NDC:76483-101-03 120 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090165 06/20/2022
ARIPIPRAZOLE
aripiprazole tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:76483-102
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
ASPARTAME
CALCIUM STEARATE
CROSPOVIDONE
MANNITOL
PEPPERMINT
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape OCTAGON (8 SIDED) (BARREL) Size 8mm
Flavor PEPPERMINT (FLAVOR FIRMENICH POWDER PEPPERMINT) Imprint Code ZF;43
Contains
Packaging
# Item Code Package Description
1 NDC:76483-102-00 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
2 NDC:76483-102-01 60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
3 NDC:76483-102-02 90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
4 NDC:76483-102-03 120 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090165 06/20/2022
ARIPIPRAZOLE
aripiprazole tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:76483-103
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
ASPARTAME
CALCIUM STEARATE
CROSPOVIDONE
MANNITOL
PEPPERMINT
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape ROUND (ROUND) Size 10mm
Flavor PEPPERMINT (FLAVOR FIRMENICH POWDER PEPPERMINT) Imprint Code ZF;44
Contains
Packaging
# Item Code Package Description
1 NDC:76483-103-00 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
2 NDC:76483-103-01 60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
3 NDC:76483-103-02 90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
4 NDC:76483-103-03 120 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090165 06/20/2022
Labeler - SQUARE PHARMACEUTICALS LIMITED (731487153)
Registrant - SQUARE PHARMACEUTICALS LIMITED (731487153)
Establishment
Name Address ID/FEI Operations
SQUARE PHARMACEUTICALS LIMITED 731487153 ANALYSIS(76483-100, 76483-101, 76483-102, 76483-103), LABEL(76483-100, 76483-101, 76483-102, 76483-103), MANUFACTURE(76483-100, 76483-101, 76483-102, 76483-103), PACK(76483-100, 76483-101, 76483-102, 76483-103)
SQUARE PHARMACEUTICALS LIMITED

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