ZEPOSIA Capsule Ref.[10374] Active ingredients: Ozanimod

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

ZEPOSIA contains ozanimod, a S1P receptor modulator and is supplied as ozanimod hydrochloride (HCl).

The chemical name of ozanimod HCl is 5-(3-{(1S)1[(2-hydroxyethyl)amino]-2,3-dihydro-1H-inden-4-yl}-1,2,4-oxadiazol-5-yl)2[(propan-2-yl)oxy]benzonitrile, monohydrochloride.

Ozanimod HCl is a white to off-white solid that is freely soluble in water and alcohol with a molecular weight of 440.92 g/mol.

The chemical structure is:

ZEPOSIA capsules are provided as hard gelatin capsules for oral administration, containing 0.23, 0.46, or 0.92 mg of ozanimod, equivalent to 0.25, 0.5, and 1 mg ozanimod HCl, respectively. ZEPOSIA capsules consist of the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The capsule shell, imprinted with black ink, contains the following inactive ingredients: black iron oxide, gelatin, red iron oxide, titanium dioxide, and yellow iron oxide.

Dosage Forms and Strengths

ZEPOSIA is available as capsules in the following dosage strengths:

  • Ozanimod 0.23 mg: light grey opaque body/light grey opaque cap imprinted with black ink “OZA” on the cap and “0.23 mg” on the body
  • Ozanimod 0.46 mg: light grey opaque body/orange opaque cap imprinted with black ink “OZA” on the cap and “0.46 mg” on the body
  • Ozanimod 0.92 mg: orange opaque body/orange opaque cap imprinted with black ink “OZA” on the cap and “0.92 mg” on the body
How Supplied

ZEPOSIA is available as capsules in the following dosage strengths:

  • Ozanimod 0.23 mg: light grey opaque body/light grey opaque cap imprinted with black ink “OZA” on the cap and “0.23 mg” on the body
  • Ozanimod 0.46 mg: light grey opaque body/orange opaque cap imprinted with black ink “OZA” on the cap and “0.46 mg” on the body
  • Ozanimod 0.92 mg: orange opaque body/orange opaque cap imprinted with black ink “OZA” on the cap and “0.92 mg” on the body

Capsules are supplied in the following strengths and package configurations:

Package configuration Tablet strength NDC number
Bottles of 30 0.92 mg 59572-820-30
7-Day Starter Pack 7-capsule starter pack containing: (4) 0.23 mg capsules and (3) 0.46 mg capsules 59572-810-07
Starter Kit
(7-Day Starter Pack and 0.92 mg 30 count Bottle) 		37-capsule starter kit including: 59572-890-91
one 7-capsule starter pack containing: (4) 0.23 mg capsules and (3) 0.46 mg capsules
and 		59572-890-07
one bottle containing (30) 0.92 mg capsules 59572-890-30

Drugs

Drug Countries
ZEPOSIA Austria, Australia, Canada, Estonia, Hong Kong, Ireland, Israel, Lithuania, Netherlands, New Zealand, Poland, Romania, United Kingdom, United States
 
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