Carnitor Injection, Solution
NDC Package 54482-147-01

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

Package Information

Carnitor (levocarnitine) injection is a medication used to prevent and treat low blood levels of carnitine. This formulation utilizes a injection, solution delivery system. Marketed by Leadiant Biosciences, Inc., this product is identified by NDC 54482-147 and is authorized under FDA application NDA020182.

Identification & Billing

NDC Package Code
54482-147-01
Package Description
5 VIAL in 1 CARTON / 5 mL in 1 VIAL
Product Code
54482-147
11-Digit Billing Format
54482014701
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Carnitor
Non-Proprietary Name
Levocarnitine
Substance Name
Levocarnitine
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
LEVOCARNITINE 1 g/5mL
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 #
NDA020182
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-16-1992
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J1955
Source: PDAC
INJECTION, LEVOCARNITINE, PER 1 GM
HCPCS Dosage 1 GM
Units / Pkg

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 54482-147-01 identifies a specific commercial package of 5 vial in 1 carton / 5 ml in 1 vial of Carnitor, a human prescription drug labeled by Leadiant Biosciences, Inc.. This injection, solution is formulated for intravenous 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 16, 1992. 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: 54482014701. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
54482-147-01
11-Digit CMS (5-4-2)
54482-0147-01

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