ingrezza valbenazine 60 mg
1 INDICATIONS AND USAGE INGREZZA and INGREZZA SPRINKLE are indicated for the treatment of adults with: - tardive dyskinesia [see Clinical Studies ( 14.1 )] . - chorea associated with Huntington’s disease [see Clinical Studies ( 14.2 )] . INGREZZA and INGREZZA SPRINKLE are vesicular monoamine transporter 2 (VMAT2) inhibitors indicated for the treatment of adults with: - tardive dyskinesia. ( 1 ) - chorea associated with Huntington’s disease. ( 1 )
neurocrine biosciences, inc.
CAPSULE RED VBZ 60
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ingrezza valbenazine 40 mg
neurocrine biosciences, inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING 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 Configuration capsule 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 x 40 mg and 21 x 80 mg NDC 70370-2048-6 4-week Initiation Pack for chorea associated with Huntington’s disease 28-day blister pack containing: 14 x 40 mg and 14 x 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 Storage INGREZZA: Store at 15°C to 30°C (59°F to 86°F). INGREZZA SPRINKLE: Store at 20°C to 25°C (68°F to 77°F). Excursions permitted between 15°C and 30°C (59°F and 86°F). Protect from moisture. Dispense in original container or in a tight container as defined in USP.
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