Leucovorin Calcium Tablet
NDC Package 0054-4497-05

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

Leucovorin Calcium tablets 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 tablet delivery system. Marketed by Hikma Pharmaceuticals Usa Inc., this product is identified by NDC 0054-4497 and is authorized under FDA application ANDA072734.

Identification & Billing

NDC Package Code
0054-4497-05
Package Description
12 TABLET in 1 BOTTLE
Product Code
0054-4497
11-Digit Billing Format
00054449705
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
12 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Leucovorin Calcium
Non-Proprietary Name
Leucovorin Calcium
Substance Name
Leucovorin Calcium
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LEUCOVORIN CALCIUM 10 mg/1
Pharmacologic Class
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
Hikma Pharmaceuticals Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA072734
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-22-1993
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

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 (0054-4497). Click a package code to view its specific billing and regulatory data.

0054-4497-10
24 TABLET in 1 BOTTLE

* 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 0054-4497-05 identifies a specific commercial package of 12 tablet in 1 bottle of Leucovorin Calcium, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. This tablet is formulated for oral 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 Hikma Pharmaceuticals Usa Inc. on February 22, 1993. 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 Hikma Pharmaceuticals Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00054449705. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 12 total billable units per package. 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 (4-4-2)
0054-4497-05
11-Digit CMS (5-4-2)
00054-4497-05

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