Aripiprazole Orally Disintegrating Tablets

Drug Facts

Composition & Product

Active Ingredients

Aripiprazole (10 mg)

Inactive Ingredients

Aspartame Calcium Stearate Crospovidone Peppermint Mannitol

Identifiers & Packaging

Pill Appearance

Imprint: ZF;44 Shape: capsule Shape: round Shape: octagon (8 sided) Color: white Size: 8 mm Size: 10 mm Score: 1

Marketing Status

ANDA Active Since 2022-07-20

Medication Information

Description

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 Orally Disintegrating Tablets 10 mg (30 Tablets in 1 Carton) Each orally disintegrating tablet contains 10 mg aripiprazole USP NDC 76483-100-04 Rx Only Aripiprazole Orally Disintegrating Tablets 15 mg (30 Tablets in 1 Carton) Each orally disintegrating tablet contains 15 mg aripiprazole USP NDC 76483-101-04 Rx Only Aripiprazole Orally Disintegrating Tablets, 20 mg (30 Tablets in 1 Carton) Each orally disintegrating tablet contains 20 mg aripiprazole USP NDC 76483-102-04 Rx Only Aripiprazole Orally Disintegrating Tablets 30 mg (30 Tablets in 1 Carton) Each orally disintegrating tablet contains 30 mg aripiprazole USP NDC 76483-103-04 Rx Only

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 Orally Disintegrating Tablets 10 mg (30 Tablets in 1 Carton)

Each orally disintegrating tablet contains 10 mg aripiprazole USP

NDC 76483-100-04

Rx Only

Aripiprazole Orally Disintegrating Tablets 15 mg (30 Tablets in 1 Carton)

Each orally disintegrating tablet contains 15 mg aripiprazole USP

NDC 76483-101-04

Rx Only

Aripiprazole Orally Disintegrating Tablets, 20 mg (30 Tablets in 1 Carton)

Each orally disintegrating tablet contains 20 mg aripiprazole USP

NDC 76483-102-04

Rx Only

Aripiprazole Orally Disintegrating Tablets 30 mg (30 Tablets in 1 Carton)

Each orally disintegrating tablet contains 30 mg aripiprazole USP

NDC 76483-103-04

Rx Only

Structured Label Content

Package Label.principal Display Panel (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 Orally Disintegrating Tablets 10 mg (30 Tablets in 1 Carton)

Each orally disintegrating tablet contains 10 mg aripiprazole USP

NDC 76483-100-04

Rx Only

Aripiprazole Orally Disintegrating Tablets 15 mg (30 Tablets in 1 Carton)

Each orally disintegrating tablet contains 15 mg aripiprazole USP

NDC 76483-101-04

Rx Only

Aripiprazole Orally Disintegrating Tablets, 20 mg (30 Tablets in 1 Carton)

Each orally disintegrating tablet contains 20 mg aripiprazole USP

NDC 76483-102-04

Rx Only

Aripiprazole Orally Disintegrating Tablets 30 mg (30 Tablets in 1 Carton)

Each orally disintegrating tablet contains 30 mg aripiprazole USP

NDC 76483-103-04

Rx Only

Advanced Ingredient Data

[{"name": "ARIPIPRAZOLE", "unii": "82VFR53I78", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "ASPARTAME", "unii": "Z0H242BBR1", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CALCIUM STEARATE", "unii": "776XM7047L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSPOVIDONE", "unii": "2S7830E561", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEPPERMINT", "unii": "V95R5KMY2B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MANNITOL", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ARIPIPRAZOLE", "unii": "82VFR53I78", "classCode": "ACTIB", "strengthNumerator": "15", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "ASPARTAME", "unii": "Z0H242BBR1", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CALCIUM STEARATE", "unii": "776XM7047L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSPOVIDONE", "unii": "2S7830E561", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEPPERMINT", "unii": "V95R5KMY2B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MANNITOL", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ARIPIPRAZOLE", "unii": "82VFR53I78", "classCode": "ACTIB", "strengthNumerator": "20", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "ASPARTAME", "unii": "Z0H242BBR1", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CALCIUM STEARATE", "unii": "776XM7047L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSPOVIDONE", "unii": "2S7830E561", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MANNITOL", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEPPERMINT", "unii": "V95R5KMY2B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ARIPIPRAZOLE", "unii": "82VFR53I78", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "ASPARTAME", "unii": "Z0H242BBR1", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CALCIUM STEARATE", "unii": "776XM7047L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSPOVIDONE", "unii": "2S7830E561", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MANNITOL", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEPPERMINT", "unii": "V95R5KMY2B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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 Orally Disintegrating Tablets 10 mg (30 Tablets in 1 Carton) Each orally disintegrating tablet contains 10 mg aripiprazole USP NDC 76483-100-04 Rx Only Aripiprazole Orally Disintegrating Tablets 15 mg (30 Tablets in 1 Carton) Each orally disintegrating tablet contains 15 mg aripiprazole USP NDC 76483-101-04 Rx Only Aripiprazole Orally Disintegrating Tablets, 20 mg (30 Tablets in 1 Carton) Each orally disintegrating tablet contains 20 mg aripiprazole USP NDC 76483-102-04 Rx Only Aripiprazole Orally Disintegrating Tablets 30 mg (30 Tablets in 1 Carton) Each orally disintegrating tablet contains 30 mg aripiprazole USP NDC 76483-103-04 Rx Only"}

Aripiprazole Orally Disintegrating Tablets

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information