Levocarnitine
NDC Package 52125-743-01

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 EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Levocarnitine is a medication a diet supplement used to prevent and treat low blood levels of carnitine. Marketed by Remedyrepack Inc., this product is identified by NDC 52125-743 and is authorized under FDA application ANDA076851.

Identification & Billing

NDC Package Code
52125-743-01
Package Description
118 mL in 1 BOTTLE, PLASTIC
Product Code
52125-743
11-Digit Billing Format
52125074301

Clinical Specifications

Proprietary Name
Levocarnitine
Dosage Form
-
Usage Information
This medication is a diet supplement 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. Carnitine comes in 2 forms, this medication (levocarnitine) and D-carnitine. An over-the-counter product called vitamin Bt contains a mixture of levocarnitine and D-carnitine. Vitamin Bt should not be used to treat serious carnitine deficiency since it can interfere with the body's use of levocarnitine. Do not use levocarnitine to treat serious carnitine deficiency unless prescribed by your doctor. The form of levocarnitine taken by mouth is not recommended for treating people on dialysis due to serious kidney disease. The injectable form should be used for this treatment. Consult your doctor for details. Some supplement products have been found to contain possibly harmful impurities/additives. Check with your pharmacist for more details about the brand you use. The FDA has not reviewed this product for safety or effectiveness. Consult your doctor or pharmacist for more details.

Regulatory & Marketing

Labeler Name
Remedyrepack Inc.
FDA Application #
ANDA076851
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-08-2013
End Marketing Date
10-08-2014
Listing Expiration
10-08-2014
Exclude Flag
D
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 (52125-743). Click a package code to view its specific billing and regulatory data.

52125-743-45
118 mL in 1 BOTTLE, PLASTIC

* 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 52125-743-01 identifies a specific commercial package of 118 ml in 1 bottle, plastic of Levocarnitine, labeled by Remedyrepack Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Remedyrepack Inc. on October 08, 2013. The current certification is valid through October 08, 2014.

What are the primary indications for this medication?

This medication is a diet supplement 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. Carnitine comes in 2 forms, this medication (levocarnitine) and D-carnitine. An over-the-counter product called vitamin Bt contains a mixture of levocarnitine and D-carnitine. Vitamin Bt should not be used to treat serious carnitine deficiency since it can interfere with the body's use of levocarnitine. Do not use levocarnitine to treat serious carnitine deficiency unless prescribed by your doctor. The form of levocarnitine taken by mouth is not recommended for treating people on dialysis due to serious kidney disease. The injectable form should be used for this treatment. Consult your doctor for details. Some supplement products have been found to contain possibly harmful impurities/additives. Check with your pharmacist for more details about the brand you use. The FDA has not reviewed this product for safety or effectiveness. Consult your doctor or pharmacist for more details.

How is this Remedyrepack Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52125074301. 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)
52125-743-01
11-Digit CMS (5-4-2)
52125-0743-01

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