1. Home
  2. Labeler Index
  3. Bayer Healthcare Pharmaceuticals Inc.
  4. 50419-385
  5. NDC Package Code: 50419-385-72 Aliqopa

NDC Package 50419-385-72 Aliqopa

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

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
50419-385-72
Package Description:
1 VIAL, SINGLE-DOSE in 1 CARTON / 4 mL in 1 VIAL, SINGLE-DOSE
Product Code:
50419-385
Proprietary Name:
Aliqopa
Non-Proprietary Name:
Copanlisib
Substance Name:
Copanlisib
Usage Information:
This medication is used to treat a certain type of cancer (follicular lymphoma). It works by slowing or stopping the growth of cancer cells.
11-Digit NDC Billing Format:
50419038572
NDC to RxNorm Crosswalk:
  • RxCUI: 1945081 - copanlisib 60 MG Injection
  • RxCUI: 1945086 - Aliqopa 60 MG Injection
  • RxCUI: 1945086 - copanlisib 60 MG Injection [Aliqopa]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Bayer Healthcare Pharmaceuticals 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):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • COPANLISIB 15 mg/mL
    • Pharmacologic Class(es):
  • Kinase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Kinase Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    Yes
    FDA Application Number:
    NDA209936
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    09-14-2017
    Listing Expiration Date:
    12-31-2024
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    50419-385-011 VIAL, SINGLE-DOSE in 1 CARTON / 4 mL in 1 VIAL, SINGLE-DOSE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 50419-385-72?

    The NDC Packaged Code 50419-385-72 is assigned to a package of 1 vial, single-dose in 1 carton / 4 ml in 1 vial, single-dose of Aliqopa, a human prescription drug labeled by Bayer Healthcare Pharmaceuticals Inc.. The product's dosage form is injection, powder, lyophilized, for solution and is administered via intravenous form.

    Is NDC 50419-385 included in the NDC Directory?

    Yes, Aliqopa with product code 50419-385 is active and included in the NDC Directory. The product was first marketed by Bayer Healthcare Pharmaceuticals Inc. on September 14, 2017 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 50419-385-72?

    The 11-digit format is 50419038572. 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
    5-3-250419-385-725-4-250419-0385-72