Agamree Kit
NDC Package 69616-264-38

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

Package Information

Agamree (vamorolone) kits is aGAMREE is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older. This formulation utilizes a kit delivery system. Marketed by Catalyst Pharmaceuticals, Inc., this product is identified by NDC 69616-264 and is authorized under FDA application NDA215239.

Identification & Billing

NDC Package Code
69616-264-38
Package Description
1 KIT in 1 CARTON * 100 mL in 1 BOTTLE, GLASS (69616-265-38)
Product Code
69616-264
11-Digit Billing Format
69616026438
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Agamree
Non-Proprietary Name
Vamorolone
Dosage Form
Kit - A packaged collection of related material.
Administration Route
Oral - Administration to or by way of the mouth.
Usage Information
AGAMREE is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older.

Regulatory & Marketing

Labeler Name
Catalyst Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA215239
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-01-2024
Listing Expiration
12-31-2027
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 69616-264-38 identifies a specific commercial package of 1 kit in 1 carton * 100 ml in 1 bottle, glass (69616-265-38) of Agamree, a human prescription drug labeled by Catalyst Pharmaceuticals, Inc.. This kit is formulated for oral use and contains 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 Catalyst Pharmaceuticals, Inc. on February 01, 2024. The current certification is valid through December 31, 2027.

How is this Catalyst Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69616026438. 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)
69616-264-38
11-Digit CMS (5-4-2)
69616-0264-38

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