EXXUA Delayed release tablet Ref.[107407] Active ingredients: Gepirone

Source: FDA, National Drug Code (US)  Revision Year: 2023 

Product description

EXXUA contains gepirone, in the salt form as gepirone hydrochloride (HCl). The chemical name is 2,6- piperidinedione,4,4-dimethyl-1-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-, monohydrochloride. The molecular weight of gepirone HCl is 395.93 and the structural formula is as follows:

Gepirone HCl is a white to off-white crystalline powder, which is readily soluble in water.

EXXUA is supplied as extended-release tablets for oral administration. Each extended-release tablet contains 18.2 mg, 36.3 mg, 54.5 mg, or 72.6 mg, gepirone equivalent to 20 mg, 40 mg, 60 mg, or 80 mg of gepirone HCl respectively. The extended-release tablets also contain the following inactive ingredients: colloidal silicon dioxide, Hypromellose, iron oxide (red and/or yellow colorants), magnesium stearate, and microcrystalline cellulose.

Dosage Forms and Strengths

EXXUA is available as extended-release tablets in the following strengths, as gepirone base:

  • 18.2 mg: pink, modified rectangular, with “FK” debossed on one side and “1” on the other side.
  • 36.3 mg: off-white, modified rectangular, with “FK” debossed on one side and “7” on the other side.
  • 54.5 mg: yellow, modified rectangular, with “FK” debossed on one side and “11” on the other side.
  • 72.6 mg: red-brown, modified rectangular, with “FK” debossed on one side and “17” on the other side.
How Supplied

EXXUA (gepirone) extended-release tablets are supplied in bottles of 100 with child-resistant caps and in four dosage strengths:

  • 18.2-mg Tablets – pink, modified rectangular, with “FK” debossed on one side and “1” on the other side. Bottles of 100 NDC 83504-150-10
  • 36.3-mg Tablets – off-white, modified rectangular, with “FK” debossed on one side and “7” on the other side. Bottles of 100 NDC 83504-151-10
  • 54.5-mg Tablets – yellow, modified rectangular, with “FK” debossed on one side and “11” on the other side. Bottles of 100 NDC 83504-152-10
  • 72.6-mg Tablets – red-brown, modified rectangular, with “FK” debossed on one side and “17” on the other side. Bottles of 100 NDC 83504-153-10

Manufactured by: Distributed by: MISSION PHARMACAL COMPANY Fabre-Kramer Pharmaceuticals, Inc., San Antonio, TX 78230 1355 Houston, TX 77057

Drugs

Drug Countries
EXXUA United States
 
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