Viltepso Injection, Solution
NDC Package 73292-011-01

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

Package Information

Viltepso (viltolarsen) injection is vILTEPSO is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. This formulation utilizes a injection, solution delivery system. Marketed by Ns Pharma, Inc., this product is identified by NDC 73292-011 and is authorized under FDA application NDA212154.

Identification & Billing

NDC Package Code
73292-011-01
Package Description
1 VIAL, GLASS in 1 CARTON / 1 INJECTION, SOLUTION in 1 VIAL, GLASS
Product Code
73292-011
11-Digit Billing Format
73292001101
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Viltepso
Non-Proprietary Name
Viltolarsen
Substance Name
Viltolarsen
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)
VILTOLARSEN 250 mg/1
Usage Information
VILTEPSO is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. This indication is approved under accelerated approval based on an increase in dystrophin production in skeletal muscle observed in patients treated with VILTEPSO [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Regulatory & Marketing

Labeler Name
Ns Pharma, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA212154
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-13-2020
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 73292-011-01 identifies a specific commercial package of 1 vial, glass in 1 carton / 1 injection, solution in 1 vial, glass of Viltepso, a human prescription drug labeled by Ns Pharma, Inc.. This injection, solution is formulated for intravenous use and contains viltolarsen 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 Ns Pharma, Inc. on August 13, 2020. The current certification is valid through December 31, 2026.

How is this Ns Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 73292001101. 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)
73292-011-01
11-Digit CMS (5-4-2)
73292-0011-01

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