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  5. NDC Package Code: 58621-002-01 Carmustine

NDC Package 58621-002-01 Carmustine

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:
58621-002-01
Package Description:
30 mL in 1 VIAL
Product Code:
58621-002
Non-Proprietary Name:
Carmustine
Substance Name:
Carmustine
Usage Information:
This medication is used to treat certain types of cancer (including multiple myeloma, brain tumor, Hodgkin's disease, non-Hodgkin's lymphoma). Carmustine belongs to a class of drugs known as alkylating agents. It works by slowing or stopping the growth of cancer cells.
11-Digit NDC Billing Format:
58621000201
Product Type:
Drug For Further Processing
Labeler Name:
Piramal Pharma Solutions 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.
Active Ingredient(s):
  • CARMUSTINE 100 mg/30mL
    • 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:
    12-29-2020
    Listing Expiration Date:
    12-31-2025
    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 58621-002-01?

    The NDC Packaged Code 58621-002-01 is assigned to an UNFINISHED drug package of 30 ml in 1 vial of Carmustine, drug for further processing labeled by Piramal Pharma Solutions Inc.. The product's dosage form is injection, powder, lyophilized, for solution and is administered via form.

    Is NDC 58621-002 included in the NDC Directory?

    Yes, Carmustine is an UNFINISHED PRODUCT with code 58621-002 that is active and included in the NDC Directory. The product was first marketed by Piramal Pharma Solutions Inc. on December 29, 2020 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 58621-002-01?

    The 11-digit format is 58621000201. 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
    5-3-258621-002-015-4-258621-0002-01