1. Home
  2. Labeler Index
  3. Chiesi Usa, Inc.
  4. 10122-210
  5. NDC Package Code: 10122-210-02 Myalept

NDC Package 10122-210-02 Myalept

Metreleptin Injection, Powder, Lyophilized, For Solution Subcutaneous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
10122-210-02
Package Description:
1 VIAL, GLASS in 1 CARTON / 2.2 mL in 1 VIAL, GLASS
Product Code:
10122-210
Proprietary Name:
Myalept
Non-Proprietary Name:
Metreleptin
Substance Name:
Metreleptin
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.
11-Digit NDC Billing Format:
10122021002
NDC to RxNorm Crosswalk:
  • RxCUI: 1491629 - metreleptin 5 MG/ML Injectable Solution
  • RxCUI: 1491629 - metreleptin 11.3 MG per 2.2 ML Injectable Solution
  • RxCUI: 1491634 - myalept 5 MG/ML Injectable Solution
  • RxCUI: 1491634 - metreleptin 5 MG/ML Injectable Solution [Myalept]
  • RxCUI: 1491634 - Myalept 11.3 MG per 2.2 ML Injectable Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Chiesi Usa, Inc.
    Dosage Form:
    Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
    Administration Route(s):
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    • Active Ingredient(s):
  • METRELEPTIN 11.3 mg/2.2mL
    • Pharmacologic Class(es):
  • Analogs/Derivatives - [Chemical/Ingredient]
  • Leptin Analog - [EPC] (Established Pharmacologic Class)
  • Leptin - [Chemical/Ingredient]
    • Sample Package:
    No
    FDA Application Number:
    BLA125390
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    03-05-2015
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 10122-210-02?

    The NDC Packaged Code 10122-210-02 is assigned to a package of 1 vial, glass in 1 carton / 2.2 ml in 1 vial, glass of Myalept, a human prescription drug labeled by Chiesi Usa, Inc.. The product's dosage form is injection, powder, lyophilized, for solution and is administered via subcutaneous form.

    Is NDC 10122-210 included in the NDC Directory?

    Yes, Myalept with product code 10122-210 is active and included in the NDC Directory. The product was first marketed by Chiesi Usa, Inc. on March 05, 2015 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 10122-210-02?

    The 11-digit format is 10122021002. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-210122-210-025-4-210122-0210-02