ZURZUVAE Capsule Ref.[107395] Active ingredients: Zuranolone

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

Product description

ZURZUVAE contains zuranolone, a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator. The chemical name is 1-[(3α, 5β)-3-hydroxy-3-methyl-20- oxo-19-norpregnan-21-yl]-1H-pyrazole-4-carbonitrile and it has the following chemical structure:

The molecular formula of zuranolone is C25H35N3O2 and the relative molecular mass is 409.57.

Zuranolone is a white to off-white, non-hygroscopic, crystalline solid. It is sparingly soluble in ethyl acetate, methanol, and ethanol; slightly soluble in methyl tert-butyl ether and isopropanol; soluble in tetrahydrofuran and acetone; and practically insoluble in water and n-heptane.

ZURZUVAE is available in 20 mg, 25 mg, and 30 mg capsules for oral administration. Each capsule contains zuranolone as the active ingredient and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, mannitol, microcrystalline cellulose, and sodium stearyl fumarate. The capsule shells contain gelatin, red iron oxide, titanium dioxide, and yellow iron oxide, and are imprinted with black ink (containing ammonium hydroxide, black iron oxide, propylene glycol, and shellac glaze).

Dosage Forms and Strengths

Capsules:

  • 20 mg: light-orange cap, ivory to light-yellow body, printed with “S-217 20 mg” on body of capsule in black
  • 25 mg: light-orange cap, light-orange body, printed with “S-217 25 mg” on body of capsule in black
  • 30 mg: orange cap, light-orange body, printed with “S-217 30 mg” on body of capsule in black
How Supplied

ZURZUVAE (zuranolone) is supplied as 20 mg, 25 mg, and 30 mg capsules as follows:

Capsule
Strength 		Capsule Colors Capsule Markings Packaging Configuration NDC
20 mg light-orange cap
ivory to light-yellow body 		Black “S-217 20 mg” on body Bottle of 14 64406-029-01
25 mg light-orange cap
light-orange body 		Black “S-217 25 mg” on body Bottle of 14 64406-030-01
Blister pack of 28 64406-030-02
30 mg orange cap
light-orange body 		Black “S-217 30 mg” on body Bottle of 14 64406-031-01

Manufactured for: Biogen Inc., 225 Binney Street, Cambridge, MA 02142 USA

Drugs

Drug Countries
ZURZUVAE United States
 
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