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  5. NDC Package Code: 69112-102-01 Lurbinectedin

NDC Package 69112-102-01 Lurbinectedin

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

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.

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:
69112-102-01
Package Description:
8 mL in 1 VIAL, SINGLE-DOSE
Product Code:
69112-102
Non-Proprietary Name:
Lurbinectedin
Substance Name:
Lurbinectedin
11-Digit NDC Billing Format:
69112010201
Product Type:
Drug For Further Processing
Labeler Name:
Gp Pharm Sa
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.
Active Ingredient(s):
  • LURBINECTEDIN 4 mg/8mL
    • Sample Package:
    N/A
    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:
    06-15-2020
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Unfinished Product:
    Yes
    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 69112-102-01?

    The NDC Packaged Code 69112-102-01 is assigned to an UNFINISHED drug package of 8 ml in 1 vial, single-dose of Lurbinectedin, drug for further processing labeled by Gp Pharm Sa. The product's dosage form is injection, powder, lyophilized, for solution and is administered via form.

    Is NDC 69112-102 included in the NDC Directory?

    Yes, Lurbinectedin is an UNFINISHED PRODUCT with code 69112-102 that is active and included in the NDC Directory. The product was first marketed by Gp Pharm Sa on June 15, 2020 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 69112-102-01?

    The 11-digit format is 69112010201. 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
    5-3-269112-102-015-4-269112-0102-01