VIIBRYD Tablet Ref.[9909] Active ingredients: Vilazodone

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

Product description

VIIBRYD tablets for oral administration contain polymorph Form IV vilazodone hydrochloride (HCl), a selective serotonin reuptake inhibitor and a 5HT1A receptor partial agonist.

Vilazodone HCl is 2-benzofurancarboxamide, 5-[4-[4-(5-cyano-1H-indol-3-yl)butyl]-1-piprazinyl]-, hydrochloride (1:1). Its molecular weight is 477.99. The structural formula is:

VIIBRYD tablets are available as 10 mg, 20 mg, and 40 mg film-coated tablets containing 10 mg, 20 mg, and 40 mg of vilazodone HCl, respectively.

In addition to the active ingredient, VIIBRYD tablets contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, FD&C Blue #1 (40 mg only), FD&C Red #40 (10 mg only), and FD&C Yellow #6 (20 mg only).

Dosage Forms and Strengths

VIIBRYD Tablets are available as 10 mg, 20 mg and 40 mg film-coated tablets.

10 mg pink, oval tablet, debossed with 10 on one side.
20 mg orange, oval tablet, debossed with 20 on one side.
40 mg blue, oval tablet, debossed with 40 on one side.
How Supplied

VIIBRYD (vilazodone HCl) tablets are supplied in the following configurations:

Tablet Strength Tablet Color/Shape Tablet Markings Package Configuration NDC Code
10 mg pink, oval tablet debossed with 10 on one side Bottle / 30 count 0456-1110-30
20 mg orange, oval tablet debossed with 20 on one side Bottle / 30 count 0456-1120-30
40 mg blue, oval tablet debossed with 40 on one side Bottle / 30 count 0456-1140-30

VIIBRYD (vilazodone HCl) Patient Starter Kits are supplied in the following configuration:

Package Configuration Tablet Strength Tablet Color/Shape Tablet Markings NDC Code
Patient Starter Kit containing seven 10 mg tablets, seven 20 mg tablets and sixteen 40 mg tablets 10 mg pink, oval tablet debossed with 10 on one side 0456-1100-31
20 mg orange, oval tablet debossed with 20 on one side
40 mg blue, oval tablet debossed with 40 on one side
Patient Starter Kit containing seven 10 mg tablets, twenty-three 20 mg tablets 10 mg pink, oval tablet debossed with 10 on one side 0456-1101-30
20 mgorange, oval tablet debossed with 20 on one side

Store tablets at 25°C (77°F). Excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].

Drugs

Drug Countries
VIIBRYD Brazil, Canada, United States
 
Next: Usage >

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.

⇈