FANAPT Tablet Ref.[10297] Active ingredients: Iloperidone

Source: FDA, National Drug Code (US)  Revision Year: 2024 

Product description

FANAPT is an atypical antipsychotic belonging to the chemical class of piperidinyl-benzisoxazole derivatives. Its chemical name is 4'[3[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]propoxy]-3'-methoxyacetophenone. Its molecular formula is C24H27FN2O4 and its molecular weight is 426.48. The structural formula is:

Iloperidone is a white to off-white finely crystalline powder. It is practically insoluble in water, very slightly soluble in 0.1 N HCl and freely soluble in chloroform, ethanol, methanol, and acetonitrile.

FANAPT tablets are intended for oral administration only. Each round, uncoated tablet contains 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of iloperidone. Inactive ingredients are: lactose monohydrate, microcrystalline cellulose, hydroxypropylmethylcellulose, crospovidone, magnesium stearate, colloidal silicon dioxide, and purified water (removed during processing). The tablets are white, round, flat, beveled-edged, and identified with a logo “fanapt_tab-us-i1!” debossed on one side and tablet strength “1”, “2”, “4”, “6”, “8”, “10”, or “12” debossed on the other side.

Dosage Forms and Strengths

FANAPT tablets are available in the following strengths: 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg. The tablets are white, round, flat, beveled-edged, and identified with a logo "" debossed on one side and tablet strength “1”, “2”, “4”, “6”, “8”, “10”, or “12” debossed on the other side.
How Supplied

FANAPT tablets are white, round and identified with a logo "" debossed on one side and tablet strength “1”, “2”, “4”, “6”, “8”, “10”, or “12” debossed on the other side. Tablets are supplied in the following strengths and package configurations:

Package Configuration Tablet Strength (mg) NDC Code
Bottles of 60 1 mg 43068-101-02
Bottles of 60 2 mg 43068-102-02
Bottles of 60 4 mg 43068-104-02
Bottles of 60 6 mg 43068-106-02
Bottles of 60 8 mg 43068-108-02
Bottles of 60 10 mg 43068-110-02
Bottles of 60 12 mg 43068-112-02
Titration Pack 2x1 mg, 2x2 mg, 2x4 mg, 2x6 mg
(Total of 8 tablets) 		43068-113-04

Distributed by: Vanda Pharmaceuticals Inc., Washington, D.C. 20037 USA

Drugs

Drug Countries
FANAPT Israel, United States
 
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