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FDA Drug information

Aripiprazole

Read time: 1 mins
Marketing start date: 18 Nov 2024
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Summary of product characteristics


Effective Time

20230702

Version

3

Spl Product Data Elements

Aripiprazole Aripiprazole ARIPIPRAZOLE ARIPIPRAZOLE ASPARTAME CALCIUM STEARATE CROSPOVIDONE PEPPERMINT MANNITOL WHITE TO OFF-WHITE FLAVOR FIRMENICH POWDER PEPPERMINT ZF;41 Aripiprazole Aripiprazole ARIPIPRAZOLE ARIPIPRAZOLE ASPARTAME CALCIUM STEARATE CROSPOVIDONE PEPPERMINT MANNITOL WHITE TO OFF-WHITE FLAVOR FIRMENICH POWDER PEPPERMINT ZF;42 Aripiprazole Aripiprazole ARIPIPRAZOLE ARIPIPRAZOLE ASPARTAME CALCIUM STEARATE CROSPOVIDONE MANNITOL PEPPERMINT WHITE TO OFF-WHITE FLAVOR FIRMENICH POWDER PEPPERMINT BARREL ZF;43 Aripiprazole Aripiprazole ARIPIPRAZOLE ARIPIPRAZOLE ASPARTAME CALCIUM STEARATE CROSPOVIDONE MANNITOL PEPPERMINT WHITE TO OFF-WHITE FLAVOR FIRMENICH POWDER PEPPERMINT ROUND ZF;44

Application Number

ANDA090165

Brand Name

Aripiprazole

Generic Name

Aripiprazole

Product Ndc

76483-101

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

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 Aripiprazole Orally Disintegrating Tablets, USP 10 mg; 30 counts Aripiprazole Orally Disintegrating Tablets, USP 10 mg; 60 Counts Aripiprazole Orally Disintegrating Tablets, USP 10 mg; 90 Counts Aripiprazole Orally Disintegrating Tablets, USP 10 mg; 120 Counts Aripiprazole Orally Disintegrating Tablets, USP 15 mg; 30 Counts Aripiprazole Orally Disintegrating Tablets, USP 15 mg; 60 Counts Aripiprazole Orally Disintegrating Tablets, USP 15 mg; 90 Counts Aripiprazole Orally Disintegrating Tablets, USP 15 mg; 120 Counts 20-30 Aripiprazole Orally Disintegrating Tablets, USP 20 mg; 60 Counts Aripiprazole Orally Disintegrating Tablets, USP 20 mg; 90 Counts Aripiprazole Orally Disintegrating Tablets, USP 20 mg; 120 Counts Aripiprazole Orally Disintegrating Tablets, USP 30 mg; 30 Counts Aripiprazole Orally Disintegrating Tablets, USP 30 mg; 60 Counts Aripiprazole Orally Disintegrating Tablets, USP 30 mg; 90 Counts Aripiprazole Orally Disintegrating Tablets, USP 30 mg; 120 Counts Aripiprazole Orally Disintegrating Tablets, 10 mg (30 Tablets in 1 Carton) Aripiprazole Orally Disintegrating Tablets, 15 mg (30 Tablets in 1 Carton) Aripiprazole Orally Disintegrating Tablets 20 mg (30 Tablets in 1 Carton) Aripiprazole Orally Disintegrating Tablets, 30 mg (30 Tablets in 1 Carton)

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