Sotradecol Injection, Solution
NDC Package 67457-162-02

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

Package Information

Sotradecol (tetradecyl hydrogen sulfate (ester)) injection is sotradecol (sodium tetradecyl sulfate injection) is indicated in the treatment of small uncomplicated varicose veins of the lower extremities that show simple dilation with competent valves. This formulation utilizes a injection, solution delivery system. Marketed by Mylan Institutional Llc, this product is identified by NDC 67457-162 and is authorized under FDA application ANDA040541.

Identification & Billing

NDC Package Code
67457-162-02
Package Description
5 VIAL, MULTI-DOSE in 1 CARTON / 2 mL in 1 VIAL, MULTI-DOSE (67457-162-00)
Product Code
67457-162
11-Digit Billing Format
67457016202
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sotradecol
Non-Proprietary Name
Tetradecyl Hydrogen Sulfate (ester)
Substance Name
Tetradecyl Hydrogen Sulfate (ester)
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
TETRADECYL HYDROGEN SULFATE (ESTER) 10 mg/mL
Usage Information
Sotradecol (sodium tetradecyl sulfate injection) is indicated in the treatment of small uncomplicated varicose veins of the lower extremities that show simple dilation with competent valves. The benefit-to-risk ratio should be considered in selected patients who are great surgical risks.

Regulatory & Marketing

Labeler Name
Mylan Institutional Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA040541
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-29-2013
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 67457-162-02 identifies a specific commercial package of 5 vial, multi-dose in 1 carton / 2 ml in 1 vial, multi-dose (67457-162-00) of Sotradecol, a human prescription drug labeled by Mylan Institutional Llc. This injection, solution is formulated for intravenous use and contains tetradecyl hydrogen sulfate (ester) 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 Mylan Institutional Llc on April 29, 2013. The current certification is valid through December 31, 2026.

How is this Mylan Institutional Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67457016202. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
67457-162-02
11-Digit CMS (5-4-2)
67457-0162-02

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