BYSANTI Tablet Ref.[116258] Active ingredients: Milsaperidone

Source: FDA, National Drug Code (US)  Revision Year: 2026 

Product description

The active ingredient in BYSANTI is milsaperidone, an atypical antipsychotic that is in the piperidinyl-benzisoxazole derivative chemical class. Its chemical name is benzenemethanol, 4-[3-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]propoxy]-3-methoxy-α- methyl-, (αS)-. Its molecular formula is C24H29FN2O4 and its molecular weight is 428.50. Milsaperidone is a white to off-white finely crystalline powder. The structural formula of milsaperidone is:

Milsaperidone is a white to off-white finely crystalline powder.

BYSANTI (milsaperidone) tablets are for oral administration only. Coated tablets contain 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of milsaperidone. Inactive ingredients are the following: colloidal silicon dioxide, crospovidone, hydroxypropylmethylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and water (removed during processing).

Dosage Forms and Strengths

Tablets:

  • 1 mg: yellow, oval shaped, debossed with "1" on one side and " " logo on other side
  • 2 mg: pink oblong oval shaped, debossed with "2" on one side and " " logo on other side
  • 4 mg: blue oval shaped, debossed with "4" on one side and " " logo on other side
  • 6 mg: orange oblong oval shaped, debossed with "6" on one side and " " logo on other side
  • 8 mg: white, oval shaped, debossed with "8" on one side and " " logo on other side
  • 10 mg: white, oblong oval shaped, debossed with "10" on one side and " " logo on other side
  • 12 mg: purple, octagon shaped, debossed with "12" on one side and " " logo on other side
How Supplied

BYSANTI (milsaperidone) tablets are supplied as follows:

  • 1 mg: yellow, oval shaped, debossed with "1" on one side and " " logo on other side
  • 2 mg: pink oblong oval shaped, debossed with "2" on one side and " " logo on other side
  • 4 mg: blue oval shaped, debossed with "4" on one side and " " logo on other side
  • 6 mg: orange oblong oval shaped, debossed with "6" on one side and " " logo on other side
  • 8 mg: white, oval shaped, debossed with "8" on one side and " " logo on other side
  • 10 mg: white, oblong oval shaped, debossed with "10" on one side and " " logo on other side
  • 12 mg: purple, octagon shaped, debossed with "12" on one side and " " logo on other side

Table 9 displays the package configurations for the single strength packages of BYSANTI (milsaperidone) tablets and Table 10 displays the package configuration for the titration packs.

Table 9. Package Configurations for the Single Strength Packages of BYSANTI (milsaperidone) Tablets:

Package ConfigurationTablet Strength (mg)NDC Code
Bottles of 601 mg43068-701-02
Bottles of 602 mg43068-702-02
Bottles of 604 mg43068-704-02
Bottles of 606 mg43068-706-02
Bottles of 608 mg43068-708-02
Bottles of 6010 mg43068-710-02
Bottles of 6012 mg43068-712-02

Table 10. Package Configurations for the Titration Packs:

Package ConfigurationIndicationTablet Quantity
and Strength (mg) 		NDC Code
Titration Pack AFor the treatment of schizophreniaTwo 1 mg tablets
Two 2 mg tablets
Two 4 mg tablets
Two 6 mg tablets
(Total of 8 tablets)		43068-713-04
Titration Pack BFor the acute treatment of manic or mixed
episodes associated with bipolar I disorder		Six 1 mg tablets
Two 2 mg tablets
Two 6 mg tablets
Two 8 mg tablets
(Total of 12 tablets)		43068-714-04
Titration Pack CFor the acute treatment of manic or mixed
episodes associated with bipolar I disorder in:
• CYP2D6 poor metabolizers
• concomitant administration with strong
CYP2D6 inhibitors and strong CYP3A4
inhibitors		Four 1 mg tablets
Two 2 mg tablets
Two 6 mg tablets
(Total of 8 tablets)		43068-715-03

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

Drugs

Drug Countries
BYSANTI United States
 
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