INGREZZA Capsule Ref.[110006] Active ingredients: Valbenazine

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

Product description

INGREZZA and INGREZZA SPRINKLE contains valbenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor, present as valbenazine tosylate salt, with the chemical name, L-Valine, (2R,3R,11bR)-1,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-yl ester, 4-methylbenzenesulfonate (1:2). Valbenazine tosylate is slightly soluble in water. Its molecular formula is C38H54N2O10S2, and its molecular weight is 762.97 g/mol (ditosylate salt) with the following structure:

The molecular formula of valbenazine free base is C24H38N2O4 and its molecular weight is 418.57.

INGREZZA is intended for oral administration only. Each capsule contains 73 mg, 109 mg or 146 mg of valbenazine tosylate equivalent to 40 mg, 60 mg or 80 mg of valbenazine free base, respectively. The capsules contain the following inactive ingredients: hypromellose, isomalt, magnesium stearate, pregelatinized starch, and silicified microcrystalline cellulose. The capsule shells contain candurin silver fine, FD&C Blue#1, FD&C Red#40, and gelatin.

INGREZZA SPRINKLE is intended for oral administration. Each capsule contains granules consisting of 73 mg, 109 mg or 146 mg of valbenazine tosylate equivalent to 40 mg, 60 mg or 80 mg of valbenazine free base, respectively. The oral granules contain the following inactive ingredients: silicified microcrystalline cellulose, isomalt, pregelatinized maize starch, hypromellose, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc in hard gelatin capsules (contains gelatin and candurin silver fine).

Dosage Forms and Strengths

INGREZZA:

  • 40 mg capsule: white opaque body and purple cap, printed with ‘VBZ’ and ‘40’ in black ink. Each capsule contains 40 mg valbenazine.
  • 60 mg capsule: dark red opaque body and purple cap, printed with ‘VBZ’ and ‘60’ in black ink. Each capsule contains 60 mg valbenazine.
  • 80 mg capsule: purple opaque body and cap, printed with ‘VBZ’ and ‘80’ in black ink. Each capsule contains 80 mg valbenazine.

INGREZZA SPRINKLE:

  • 40 mg capsule: pearl white opaque cap and body, printed with a band, directional arrows, and “VBZ 40” in black ink on both the cap and body. Each capsule contains 40 mg valbenazine.
  • 60 mg capsule: pearl white opaque cap and body, printed with a band, directional arrows, and “VBZ 60” in dark red ink on both the cap and body. Each capsule contains 60 mg valbenazine.
  • 80 mg capsule: pearl white opaque cap and body, printed with a band, directional arrows, and “VBZ 80” in purple ink on both the cap and body. Each capsule contains 80 mg valbenazine.
How Supplied

INGREZZA (valbenazine) capsules are available as:

40 mg Capsule: White opaque body with a purple cap, printed with ‘VBZ’ and ‘40’ in black ink.

60 mg Capsule: Dark red opaque body with a purple cap, printed with ‘VBZ’ and ‘60’ in black ink.

80 mg Capsule: Purple opaque body and cap, printed with ‘VBZ’ and ‘80’ in black ink.

INGREZZA SPRINKLE (valbenazine) capsules are available as:

40 mg Capsule: Pearl white opaque cap and body, printed with a band, directional arrows, and “VBZ 40” in black ink on both the cap and body.

60 mg Capsule: Pearl white opaque cap and body, printed with a band, directional arrows, and “VBZ 60” in dark red ink on both the cap and body.

80 mg Capsule: Pearl white opaque cap and body, printed with a band, directional arrows, and “VBZ 80” in purple ink on both the cap and body.

Table 6. INGREZZA and INGREZZA SPRINKLE Configurations and NDC Numbers:

Package ConfigurationCapsule Strength NDC Number
INGREZZA
Bottle of 30 40 mg NDC 70370-2040-1
Bottle of 30 60 mg NDC 70370-1060-1
Bottle of 30 80 mg NDC 70370-1080-1
4-week Initiation Pack
for tardive dyskinesia 		28-day blister pack containing:
7 × 40 mg and 21 × 80 mg 		NDC 70370-2048-6
4-week Initiation Pack
for chorea associated with Huntington’s disease 		28-day blister pack containing:
14 × 40 mg and 14 × 60 mg 		NDC 70370-2046-1
INGREZZA SPRINKLE
Bottle of 30 40 mg NDC 70370-4040-1
Bottle of 30 60 mg NDC 70370-4060-1
Bottle of 30 80 mg NDC 70370-4080-1

Distributed by: Neurocrine Biosciences, Inc., 12780 El Camino Real, San Diego, CA 92130

Drugs

Drug Countries
INGREZZA United States
 
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