Levocarnitine Solution
NDC Package 64980-503-12

11-digit billing NDC: 64980050312 · Billing unit: ML · 118 ML per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Levocarnitine solution is levocarnitine Oral Solution USP is indicated in the treatment of primary systemic carnitine deficiency. This formulation utilizes a solution delivery system. Marketed by Rising Pharma Holdings, Inc., this product is identified by NDC 64980-503 and is authorized under FDA application ANDA076851.

Identification & Billing

NDC Package Code
64980-503-12
Package Description
118 mL in 1 BOTTLE, PLASTIC
Product Code
64980-503
11-Digit Billing Format
64980050312
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
118 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Levocarnitine
Non-Proprietary Name
Levocarnitine
Substance Name
Levocarnitine
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LEVOCARNITINE 1 g/10mL
Pharmacologic Class
Usage Information
Levocarnitine Oral Solution USP is indicated in the treatment of primary systemic carnitine deficiency. In the reported cases, the clinical presentation consisted of recurrent episodes of Reye-like encephalopathy, hypoketotic hypoglycemia, and/or cardiomyopathy. Associated symptoms included hypotonia, muscle weakness and failure to thrive. A diagnosis of primary carnitine deficiency requires that serum, red cell and/or tissue carnitine levels be low and that the patient does not have a primary defect in fatty acid or organic acid oxidation (see Clinical Pharmacology). In some patients, particularly those presenting with cardiomyopathy, carnitine supplementation rapidly alleviated signs and symptoms. Treatment should include, in addition to carnitine, supportive and other therapy as indicated by the condition of the patient. Levocarnitine Oral Solution USP is also indicated for acute and chronic treatment of patients with an inborn error of metabolism which results in a secondary carnitine deficiency.

Regulatory & Marketing

Labeler Name
Rising Pharma Holdings, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA076851
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-20-2004
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 64980-503-12 identifies a specific commercial package of 118 ml in 1 bottle, plastic of Levocarnitine, a human prescription drug labeled by Rising Pharma Holdings, Inc.. This solution 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 Rising Pharma Holdings, Inc. on September 20, 2004. The current certification is valid through December 31, 2026.

How is this Rising Pharma Holdings, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64980050312. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 118 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)
64980-503-12
11-Digit CMS (5-4-2)
64980-0503-12

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