Source: FDA, National Drug Code (US) Revision Year: 2020
JADENU (deferasirox) is an iron-chelating agent provided as a tablet or granules for oral use. Deferasirox is designated chemically as 4-[3,5-bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]benzoic acid and has the following structural formula:
Deferasirox is a white to slightly yellow powder. It has a molecular formula C21H15N3O4 and molecular weight of 373.4 g/mol. It is insoluble in water with a pH of suspension of 4.1.
JADENU tablets contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, poloxamer (188), and povidone (K30). The film coating contains opadry blue.
JADENU Sprinkle granules contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone (K30), poloxamer (188).
| Dosage Forms and Strengths |
|---|
|
90 mg JADENU tablets: Light blue oval biconvex film-coated tablet with beveled edges, debossed with “NVR” on one side and ‘90’ on a slight upward slope in between two debossed curved lines on the other side. 180 mg JADENU tablets: Medium blue oval biconvex film-coated tablet with beveled edges, debossed with “NVR” on one side and ‘180’ on a slight upward slope in between two debossed curved lines on the other side. 360 mg JADENU tablets: Dark blue oval biconvex film-coated tablet with beveled edges, debossed with “NVR” on one side and ‘360’ on a slight upward slope in between two debossed curved lines on the other side. 90 mg JADENU Sprinkle granules: Supplied in cartons containing 30 child resistant foil sachets. Each sachet contains 162 mg of white to almost white granules, equivalent to 90 mg deferasirox. 180 mg JADENU Sprinkle granules: Supplied in cartons containing 30 child resistant foil sachets. Each sachet contains 324 mg of white to almost white granules, equivalent to 180 mg deferasirox. 360 mg JADENU Sprinkle granules: Supplied in cartons containing 30 child resistant foil sachets. Each sachet contains 648 mg of white to almost white granules, equivalent to 360 mg deferasirox. |
| How Supplied |
|---|
|
JADENU 90 mg tablets are light blue in color, film-coated, oval biconvex tablets with beveled edges, debossed with ‘NVR’ on one side and ‘90’ on a slight upward slope in between two debossed curved lines on the other side. They are available in bottles of 30 tablets (NDC 0078-0654-15) JADENU 180 mg tablets are medium blue in color, film-coated, oval biconvex tablet with beveled edges, debossed with ‘NVR’ on one side and ‘180’ on a slight upward slope in between two debossed curved lines on the other side. They are available in bottles of 30 tablets (NDC 0078-0655-15) JADENU 360 mg tablets are dark blue in color, film-coated, oval biconvex tablet with beveled edges, debossed with ‘NVR’ on one side and ‘360’ on a slight upward slope in between two debossed curved lines on the other side. They are available in bottles of 30 tablets (NDC 0078-0656-15) JADENU Sprinkle 90 mg granules are white to almost white granules in sachet. They are available in cartons of 30 sachets (NDC 0078-0727-15) JADENU Sprinkle 180 mg granules are white to almost white granules in sachet. They are available in cartons of 30 sachets (NDC 0078-0713-15) JADENU Sprinkle 360 mg granules are white to almost white granules in sachet. They are available in cartons of 30 sachets (NDC 0078-0720-15) Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936 |
| Drug | Countries | |
|---|---|---|
| JADENU | Australia, Canada, Hong Kong, Japan, Singapore, Tunisia, United States, South Africa |
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