INGREZZA Capsule Ref.[9910] Active ingredients: Valbenazine

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

Product description

INGREZZA 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 capsules are intended for oral administration only. Each capsule contains 73 mg or 146 mg of valbenazine tosylate equivalent to 40 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.

Dosage Forms and Strengths

INGREZZA capsules are available in the following strengths:

  • 40 mg capsules with a white opaque body and purple cap, printed with ‘VBZ’ and ‘40’ in black ink.
  • 80 mg capsules with a purple opaque body and cap, printed with ‘VBZ’ and ‘80’ in black ink.
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.

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

Package Configuration Capsule Strength NDC Number
Bottle of 30 40 mg NDC 70370-2040-1
Bottle of 30 80 mg NDC 70370-1080-1
4-week Initiation Pack 28-day blister pack containing:
7 × 40 mg (Size 2) and 21 × 80 mg 		NDC 70370-2048-6

Drugs

Drug Countries
INGREZZA United States
 
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