Carnitor Tablet
NDC Package 54482-144-07

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Carnitor (levocarnitine) tablets is a medication used to prevent and treat low blood levels of carnitine. This formulation utilizes a tablet delivery system. Marketed by Leadiant Biosciences, Inc., this product is identified by NDC 54482-144 and is authorized under FDA application NDA018948.

Identification & Billing

NDC Package Code
54482-144-07
Package Description
10 BLISTER PACK in 1 CARTON / 9 TABLET in 1 BLISTER PACK
Product Code
54482-144
11-Digit Billing Format
54482014407
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
10 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Carnitor
Non-Proprietary Name
Levocarnitine
Substance Name
Levocarnitine
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)
LEVOCARNITINE 330 mg/1
Pharmacologic Class
Usage Information
This medication is used to prevent and treat low blood levels of carnitine. Carnitine is a substance made in the body from meat and dairy products. It helps the body use certain chemicals (long-chain fatty acids) for energy and to keep you in good health. Low blood levels of carnitine may occur in people whose bodies cannot properly use carnitine from their diets, people on dialysis due to serious kidney disease, and people being treated with certain drugs (e.g., valproic acid, zidovudine). Carnitine levels that are too low can cause liver, heart, and muscle problems. The injectable form of this drug is recommended if you have serious kidney disease (e.g., ESRD/dialysis) because high doses of the form taken by mouth may increase the risk of serious side effects. Consult your doctor or pharmacist for details.

Regulatory & Marketing

Labeler Name
Leadiant Biosciences, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA018948
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-27-1985
Listing Expiration
12-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 54482-144-07 identifies a specific commercial package of 10 blister pack in 1 carton / 9 tablet in 1 blister pack of Carnitor, a human prescription drug labeled by Leadiant Biosciences, Inc.. This tablet is formulated for oral use and contains levocarnitine 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 Leadiant Biosciences, Inc. on December 27, 1985. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to prevent and treat low blood levels of carnitine. Carnitine is a substance made in the body from meat and dairy products. It helps the body use certain chemicals (long-chain fatty acids) for energy and to keep you in good health. Low blood levels of carnitine may occur in people whose bodies cannot properly use carnitine from their diets, people on dialysis due to serious kidney disease, and people being treated with certain drugs (e.g., valproic acid, zidovudine). Carnitine levels that are too low can cause liver, heart, and muscle problems. The injectable form of this drug is recommended if you have serious kidney disease (e.g., ESRD/dialysis) because high doses of the form taken by mouth may increase the risk of serious side effects. Consult your doctor or pharmacist for details.

How is this Leadiant Biosciences, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54482014407. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 10 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 (5-3-2)
54482-144-07
11-Digit CMS (5-4-2)
54482-0144-07

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