Vamorolone Suspension
NDC Package 62450-003-01

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Vamorolone suspension is a drug for further processing. This formulation utilizes a suspension delivery system. Marketed by Purna Pharmaceuticals Nv, this product is identified by NDC 62450-003.

Identification & Billing

NDC Package Code
62450-003-01
Package Description
100 mL in 1 BOTTLE
Product Code
62450-003
11-Digit Billing Format
62450000301

Clinical Specifications

Proprietary Name
Vamorolone
Non-Proprietary Name
Vamorolone
Substance Name
Vamorolone
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Active Ingredient(s)
VAMOROLONE 40 mg/mL

Regulatory & Marketing

Labeler Name
Purna Pharmaceuticals Nv
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
11-23-2023
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 62450-003-01 identifies a specific commercial package of 100 ml in 1 bottle of Vamorolone (UNFINISHED drug), drug for further processing labeled by Purna Pharmaceuticals Nv. This suspension is formulated for use and contains vamorolone 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 Purna Pharmaceuticals Nv on November 23, 2023. The current certification is valid through December 31, 2026.

How is this Purna Pharmaceuticals Nv product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62450000301. 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)
62450-003-01
11-Digit CMS (5-4-2)
62450-0003-01

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