Varithena Kit
NDC Package 60635-133-01

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

Package Information

Varithena (polidocanol) kits is vARITHENA (polidocanol injectable foam) is indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the great saphenous vein (GSV) system above and below the knee. This formulation utilizes a kit delivery system. Marketed by Boston Scientific Corporation, this product is identified by NDC 60635-133 and is authorized under FDA application NDA205098.

Identification & Billing

NDC Package Code
60635-133-01
Package Description
1 CARTON in 1 PACKAGE / 1 POUCH in 1 CARTON / 1 KIT in 1 POUCH * 18 mL in 1 CANISTER (60635-018-01) * 303 mL in 1 CANISTER
Product Code
60635-133
11-Digit Billing Format
60635013301
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Varithena
Non-Proprietary Name
Polidocanol
Dosage Form
Kit - A packaged collection of related material.
Usage Information
VARITHENA (polidocanol injectable foam) is indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the great saphenous vein (GSV) system above and below the knee. VARITHENA improves the symptoms of superficial venous incompetence and the appearance of visible varicosities.

Regulatory & Marketing

Labeler Name
Boston Scientific Corporation
Product Type
Human Prescription Drug
FDA Application #
NDA205098
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-25-2013
Listing Expiration
12-31-2027
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 60635-133-01 identifies a specific commercial package of 1 carton in 1 package / 1 pouch in 1 carton / 1 kit in 1 pouch * 18 ml in 1 canister (60635-018-01) * 303 ml in 1 canister of Varithena, a human prescription drug labeled by Boston Scientific Corporation. This kit is formulated for use and contains 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 Boston Scientific Corporation on November 25, 2013. The current certification is valid through December 31, 2027.

How is this Boston Scientific Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60635013301. 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)
60635-133-01
11-Digit CMS (5-4-2)
60635-0133-01

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