L-5-mthf Powder
NDC Package 76438-005-01

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.

L-5-mthf powders is folic acid is the man-made form of folate. This formulation utilizes a powder delivery system. Marketed by Anthem Biosciences Limited, this product is identified by NDC 76438-005.

Identification & Billing

NDC Package Code
76438-005-01
Package Description
12000 g in 1 DRUM
Product Code
76438-005
11-Digit Billing Format
76438000501

Clinical Specifications

Proprietary Name
L-5-mthf
Non-Proprietary Name
L-5-mthf
Substance Name
Levomefolate Calcium
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)
LEVOMEFOLATE CALCIUM 1 g/g
Usage Information
Folic acid is the man-made form of folate. Folate is a B-vitamin naturally found in some foods. It is needed to form healthy cells, especially red blood cells. Folic acid supplements may come in different forms (such as L-methylfolate, levomefolate, methyltetrahydrofolate). They are used to treat or prevent low folate levels. Low folate levels can lead to certain types of anemia. Conditions that can cause low folate levels include poor diet, pregnancy, alcoholism, liver disease, certain stomach/intestinal problems, kidney dialysis, among others. Women of childbearing age should receive adequate amounts of folic acid either through their diet or supplements to prevent infant spinal cord birth defects.

Regulatory & Marketing

Labeler Name
Anthem Biosciences Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING - A category specifying that a bulk product is intended for use on humans and requires a prescription.
Start Marketing Date
12-01-2021
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 76438-005-01 identifies a specific commercial package of 12000 g in 1 drum of L-5-mthf (UNFINISHED drug), a bulk ingredient labeled by Anthem Biosciences Limited. This powder is formulated for use and contains levomefolate calcium 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 Anthem Biosciences Limited on December 01, 2021. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Folic acid is the man-made form of folate. Folate is a B-vitamin naturally found in some foods. It is needed to form healthy cells, especially red blood cells. Folic acid supplements may come in different forms (such as L-methylfolate, levomefolate, methyltetrahydrofolate). They are used to treat or prevent low folate levels. Low folate levels can lead to certain types of anemia. Conditions that can cause low folate levels include poor diet, pregnancy, alcoholism, liver disease, certain stomach/intestinal problems, kidney dialysis, among others. Women of childbearing age should receive adequate amounts of folic acid either through their diet or supplements to prevent infant spinal cord birth defects.

How is this Anthem Biosciences Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76438000501. 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)
76438-005-01
11-Digit CMS (5-4-2)
76438-0005-01

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