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  5. NDC Package Code: 60635-133-01 Varithena

NDC Package 60635-133-01 Varithena

Polidocanol Kit - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

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
Proprietary Name:
Varithena
Non-Proprietary Name:
Polidocanol
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.
11-Digit NDC Billing Format:
60635013301
NDC to RxNorm Crosswalk:
  • RxCUI: 1485068 - polidocanol 180 MG in 18 ML Injectable Foam
  • RxCUI: 1485068 - polidocanol 10 MG/ML Injectable Foam
  • RxCUI: 1485068 - polidocanol 1 % Injectable Foam
  • RxCUI: 1485068 - polidocanol 180 MG per 18 ML Injectable Foam
  • RxCUI: 1485070 - Varithena 180 MG in 18 ML Injectable Foam
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Biocompatibles, Inc.
    Dosage Form:
    Kit - A packaged collection of related material.
    Sample Package:
    No
    FDA Application Number:
    NDA205098
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    11-25-2013
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 60635-133-01?

    The NDC Packaged Code 60635-133-01 is assigned to a 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 Biocompatibles, Inc.. The product's dosage form is kit and is administered via form.

    Is NDC 60635-133 included in the NDC Directory?

    Yes, Varithena with product code 60635-133 is active and included in the NDC Directory. The product was first marketed by Biocompatibles, Inc. on November 25, 2013 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 60635-133-01?

    The 11-digit format is 60635013301. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-260635-133-015-4-260635-0133-01