Vilazodone Hydrochloride Tablet, Film Coated
NDC Package 76282-545-30

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Vilazodone Hydrochloride tablets is vilazodone hydrochloride is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)]. This formulation utilizes a tablet, film coated delivery system. Marketed by Exelan Pharmaceuticals Inc., this product is identified by NDC 76282-545 and is authorized under FDA application ANDA208200.

Identification & Billing

NDC Package Code
76282-545-30
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
76282-545
11-Digit Billing Format
76282054530
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Vilazodone Hydrochloride
Non-Proprietary Name
Vilazodone Hydrochloride
Substance Name
Vilazodone Hydrochloride
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
VILAZODONE HYDROCHLORIDE 20 mg/1
Usage Information
Vilazodone hydrochloride is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)] .

Regulatory & Marketing

Labeler Name
Exelan Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA208200
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-01-2022
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 76282-545-30 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Vilazodone Hydrochloride, a human prescription drug labeled by Exelan Pharmaceuticals Inc.. This tablet, film coated is formulated for oral use and contains vilazodone hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Exelan Pharmaceuticals Inc. on December 01, 2022. The current certification is valid through December 31, 2026.

How is this Exelan Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76282054530. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
76282-545-30
11-Digit CMS (5-4-2)
76282-0545-30

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.