Levofolinic Acid Crystalline Powder
NDC Package 54239-014-01

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 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.

Levofolinic Acid Crystalline powders is a medication used to treat or prevent serious blood cell disorders (such as thrombocytopenia, neutropenia, anemia) caused by certain drugs (folic acid antagonists such as methotrexate, trimethoprim, pyrimethamine). This formulation utilizes a powder delivery system. Marketed by Cerbios-pharma Sa, this product is identified by NDC 54239-014.

Identification & Billing

NDC Package Code
54239-014-01
Package Description
15 kg in 1 CONTAINER
Product Code
54239-014
11-Digit Billing Format
54239001401

Clinical Specifications

Proprietary Name
Levofolinic Acid Crystalline
Non-Proprietary Name
Levofolinic Acid Crystalline
Substance Name
Levoleucovorin
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
LEVOLEUCOVORIN 1 kg/kg
Usage Information
This medication is used to treat or prevent serious blood cell disorders (such as thrombocytopenia, neutropenia, anemia) caused by certain drugs (folic acid antagonists such as methotrexate, trimethoprim, pyrimethamine). Some brands may also be used with a certain cancer drug (5-fluorouracil) to treat patients with colon cancer.

Regulatory & Marketing

Labeler Name
Cerbios-pharma Sa
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
01-19-2016
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 54239-014-01 identifies a specific commercial package of 15 kg in 1 container of Levofolinic Acid Crystalline (UNFINISHED drug), a bulk ingredient labeled by Cerbios-pharma Sa. This powder is formulated for use and contains levoleucovorin as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Cerbios-pharma Sa on January 19, 2016. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat or prevent serious blood cell disorders (such as thrombocytopenia, neutropenia, anemia) caused by certain drugs (folic acid antagonists such as methotrexate, trimethoprim, pyrimethamine). Some brands may also be used with a certain cancer drug (5-fluorouracil) to treat patients with colon cancer.

How is this Cerbios-pharma Sa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54239001401. 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)
54239-014-01
11-Digit CMS (5-4-2)
54239-0014-01

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