Varenicline
NDC Package 82582-481-56

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Varenicline is a . Marketed by Avalanche Pharmaceutical Llc, this product is identified by NDC 82582-481 and is authorized under FDA application ANDA217283.

Identification & Billing

NDC Package Code
82582-481-56
Package Description
56 TABLET, FILM COATED in 1 BOTTLE
Product Code
82582-481
11-Digit Billing Format
82582048156

Clinical Specifications

Proprietary Name
Varenicline
Dosage Form
-

Regulatory & Marketing

Labeler Name
Avalanche Pharmaceutical Llc
FDA Application #
ANDA217283
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-19-2024
End Marketing Date
04-09-2025
Listing Expiration
04-09-2025
Exclude Flag
D
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 82582-481-56 identifies a specific commercial package of 56 tablet, film coated in 1 bottle of Varenicline, labeled by Avalanche Pharmaceutical Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Avalanche Pharmaceutical Llc on March 19, 2024. The current certification is valid through April 09, 2025.

How is this Avalanche Pharmaceutical Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82582048156. 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)
82582-481-56
11-Digit CMS (5-4-2)
82582-0481-56

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