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  5. NDC Package Code: 0517-1045-05 Levocarnitine

NDC Package 0517-1045-05 Levocarnitine

Injection, Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0517-1045-05
Package Description:
5 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE (0517-1045-01)
Product Code:
0517-1045
Proprietary Name:
Levocarnitine
Non-Proprietary Name:
Levocarnitine
Substance Name:
Levocarnitine
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.
11-Digit NDC Billing Format:
00517104505
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
American Regent, Inc.
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(s):
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s):
LEVOCARNITINE 200 mg/mL
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
ANDA075861
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
06-21-2023
Listing Expiration Date:
12-31-2025
Exclude Flag:
N
Code Structure:

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 disclaimer below.

NDC HCPCS Crosswalk

This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

NDC 0517-1045-05 HCPCS crosswalk information with package details and bill units information.

NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
00517104505J1955Inj levocarnitine per 1 gm1 GM5515

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 0517-1045-05?

The NDC Packaged Code 0517-1045-05 is assigned to a package of 5 vial, single-dose in 1 carton / 5 ml in 1 vial, single-dose (0517-1045-01) of Levocarnitine, a human prescription drug labeled by American Regent, Inc.. The product's dosage form is injection, solution and is administered via intravenous form.

Is NDC 0517-1045 included in the NDC Directory?

Yes, Levocarnitine with product code 0517-1045 is active and included in the NDC Directory. The product was first marketed by American Regent, Inc. on June 21, 2023 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0517-1045-05?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

What is the 11-digit format for NDC 0517-1045-05?

The 11-digit format is 00517104505. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
4-4-20517-1045-055-4-200517-1045-05