Myalept
NDC Package 76431-210-01

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 EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Myalept is (metreleptin) for injection is indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy.Limitations of UseThe safety and effectiveness of MYALEPT for the treatment of complications of partial lipodystrophy have not been established.The safety and effectiveness of MYALEPT for the treatment of liver disease, including nonalcoholic steatohepatitis (NASH), have not been established.MYALEPT is not indicated for use in patients with HIV-related lipodystrophy.MYALEPT is not indicated for use in patients with metabolic disease, including diabetes mellitus and hypertriglyceridemia, without concurrent evidence of congenital or acquired generalized lipodystrophy. Marketed by Amryt Pharmaceuticals Designated Activity Company, this product is identified by NDC 76431-210 and is authorized under FDA application BLA125390.

Identification & Billing

NDC Package Code
76431-210-01
Package Description
1 VIAL, GLASS in 1 CARTON / 2.2 mL in 1 VIAL, GLASS
Product Code
76431-210
11-Digit Billing Format
76431021001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Myalept
Dosage Form
-
Usage Information
MYALEPT (metreleptin) for injection is indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy.Limitations of UseThe safety and effectiveness of MYALEPT for the treatment of complications of partial lipodystrophy have not been established.The safety and effectiveness of MYALEPT for the treatment of liver disease, including nonalcoholic steatohepatitis (NASH), have not been established.MYALEPT is not indicated for use in patients with HIV-related lipodystrophy.MYALEPT is not indicated for use in patients with metabolic disease, including diabetes mellitus and hypertriglyceridemia, without concurrent evidence of congenital or acquired generalized lipodystrophy.

Regulatory & Marketing

Labeler Name
Amryt Pharmaceuticals Designated Activity Company
FDA Application #
BLA125390
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
03-05-2015
End Marketing Date
09-25-2025
Listing Expiration
09-25-2025
Exclude Flag
D
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 76431-210-01 identifies a specific commercial package of 1 vial, glass in 1 carton / 2.2 ml in 1 vial, glass of Myalept, labeled by Amryt Pharmaceuticals Designated Activity Company. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Amryt Pharmaceuticals Designated Activity Company on March 05, 2015. The current certification is valid through September 25, 2025.

How is this Amryt Pharmaceuticals Designated Activity Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76431021001. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
76431-210-01
11-Digit CMS (5-4-2)
76431-0210-01

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