(sotradecol) Sodium Tetradecyl Sulfate Injection, Solution
NDC Package 51662-1563-1

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

Package Information

(sotradecol) Sodium Tetradecyl Sulfate 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 Hf Acquisition Co Llc, Dba Healthfirst, this product is identified by NDC 51662-1563 and is authorized under FDA application ANDA040541.

Identification & Billing

NDC Package Code
51662-1563-1
Package Description
2 mL in 1 VIAL, MULTI-DOSE
Product Code
51662-1563
11-Digit Billing Format
51662156301
RxNorm Crosswalk
  • RxCUI: 204491 - sodium tetradecyl sulfate 3 % Injectable Solution
  • RxCUI: 204491 - sodium tetradecyl sulfate 30 MG/ML Injectable Solution

Clinical Specifications

Proprietary Name
(sotradecol) Sodium Tetradecyl Sulfate
Non-Proprietary Name
(sotradecol) Sodium Tetradecyl Sulfate
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) 30 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
Hf Acquisition Co Llc, Dba Healthfirst
Product Type
Human Prescription Drug
FDA Application #
ANDA040541
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-25-2021
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 51662-1563-1 identifies a specific commercial package of 2 ml in 1 vial, multi-dose of (sotradecol) Sodium Tetradecyl Sulfate, a human prescription drug labeled by Hf Acquisition Co Llc, Dba Healthfirst. 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 Hf Acquisition Co Llc, Dba Healthfirst on June 25, 2021. The current certification is valid through December 31, 2026.

How is this Hf Acquisition Co Llc, Dba Healthfirst product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51662156301. 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 (5-4-1)
51662-1563-1
11-Digit CMS (5-4-2)
51662-1563-01

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