Forzinity Injection
NDC Package 72507-800-04

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

Package Information

Forzinity (elamipretide hydrochloride) injection is fORZINITY is indicated to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg.This indication is approved under accelerated approval based on an improvement in knee extensor muscle strength, an intermediate clinical endpoint [see Clinical Studies (14)]. This formulation utilizes a injection delivery system. Marketed by Stealth Biotherapeutics Inc., this product is identified by NDC 72507-800 and is authorized under FDA application NDA215244.

Identification & Billing

NDC Package Code
72507-800-04
Package Description
4 VIAL in 1 CARTON / 3.5 mL in 1 VIAL (72507-800-30)
Product Code
72507-800
11-Digit Billing Format
72507080004
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Forzinity
Non-Proprietary Name
Elamipretide Hydrochloride
Substance Name
Elamipretide Hydrochloride
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
ELAMIPRETIDE HYDROCHLORIDE 280 mg/3.5mL
Usage Information
FORZINITY is indicated to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg.This indication is approved under accelerated approval based on an improvement in knee extensor muscle strength, an intermediate clinical endpoint [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
Stealth Biotherapeutics Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA215244
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-30-2025
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 72507-800-04 identifies a specific commercial package of 4 vial in 1 carton / 3.5 ml in 1 vial (72507-800-30) of Forzinity, a human prescription drug labeled by Stealth Biotherapeutics Inc.. This injection is formulated for subcutaneous use and contains elamipretide hydrochloride 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 Stealth Biotherapeutics Inc. on October 30, 2025. The current certification is valid through December 31, 2026.

How is this Stealth Biotherapeutics Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72507080004. 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)
72507-800-04
11-Digit CMS (5-4-2)
72507-0800-04

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