Leucovorin Calcium Powder
NDC Package 69723-003-04

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. 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.

Leucovorin Calcium 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 Molclone Labs Private Limited, this product is identified by NDC 69723-003.

Identification & Billing

NDC Package Code
69723-003-04
Package Description
500 g in 1 POUCH
Product Code
69723-003
11-Digit Billing Format
69723000304

Clinical Specifications

Proprietary Name
Leucovorin Calcium
Non-Proprietary Name
Leucovorin Calcium
Substance Name
Leucovorin 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)
LEUCOVORIN CALCIUM 1000 g/1000g
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). It may also be used with a certain cancer drug (5-fluorouracil) to treat patients with colon cancer. Leucovorin may also be used to treat a certain type of anemia (due to folic acid deficiency) when folic acid cannot be taken by mouth.

Regulatory & Marketing

Labeler Name
Molclone Labs Private 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
01-13-2026
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (69723-003). Click a package code to view its specific billing and regulatory data.

69723-003-01
25 g in 1 POUCH
69723-003-02
50 g in 1 POUCH
69723-003-03
100 g in 1 POUCH
69723-003-05
1000 g in 1 POUCH
69723-003-06
300 g in 1 POUCH

* 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 69723-003-04 identifies a specific commercial package of 500 g in 1 pouch of Leucovorin Calcium (UNFINISHED drug), a bulk ingredient labeled by Molclone Labs Private Limited. This powder is formulated for use and contains leucovorin 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 Molclone Labs Private Limited on January 13, 2026. The current certification is valid through December 31, 2027.

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). It may also be used with a certain cancer drug (5-fluorouracil) to treat patients with colon cancer. Leucovorin may also be used to treat a certain type of anemia (due to folic acid deficiency) when folic acid cannot be taken by mouth.

How is this Molclone Labs Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69723000304. 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)
69723-003-04
11-Digit CMS (5-4-2)
69723-0003-04

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