Uvadex Injection, Solution
NDC Package 64067-216-01

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

Package Information

Uvadex (methoxsalen) injection is a medication used along with controlled ultraviolet light (UVA) to help control severe psoriasis. This formulation utilizes a injection, solution delivery system. Marketed by Therakos Llc, this product is identified by NDC 64067-216 and is authorized under FDA application NDA020969.

Identification & Billing

NDC Package Code
64067-216-01
Package Description
12 VIAL, GLASS in 1 CARTON / 10 mL in 1 VIAL, GLASS
Product Code
64067-216
11-Digit Billing Format
64067021601
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Uvadex
Non-Proprietary Name
Methoxsalen
Substance Name
Methoxsalen
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
Extracorporeal - Administration outside of the body.
Active Ingredient(s)
METHOXSALEN 20 ug/mL
Pharmacologic Class
Usage Information
This medication is used along with controlled ultraviolet light (UVA) to help control severe psoriasis. Methoxsalen works by making the skin more sensitive to UVA light. This combination helps to slow the overgrowth of skin cells. This medication is not recommended for use in children younger than 12 years.

Regulatory & Marketing

Labeler Name
Therakos Llc
Product Type
Human Prescription Drug
FDA Application #
NDA020969
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-25-1999
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 64067-216-01 identifies a specific commercial package of 12 vial, glass in 1 carton / 10 ml in 1 vial, glass of Uvadex, a human prescription drug labeled by Therakos Llc. This injection, solution is formulated for extracorporeal use and contains methoxsalen 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 Therakos Llc on February 25, 1999. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used along with controlled ultraviolet light (UVA) to help control severe psoriasis. Methoxsalen works by making the skin more sensitive to UVA light. This combination helps to slow the overgrowth of skin cells. This medication is not recommended for use in children younger than 12 years.

How is this Therakos Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64067021601. 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)
64067-216-01
11-Digit CMS (5-4-2)
64067-0216-01

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