Elcys Injection, Solution
NDC Package 51754-1007-3

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

Elcys (cysteine hydrochloride) injection is eLCYS is indicated for use as an additive to amino acid solutions to meet the nutritional requirements of newborn infantsrequiring total parenteral nutrition (TPN) and of adult and pediatric patients with severe liver disease who may haveimpaired enzymatic processes and require TPN. This formulation utilizes a injection, solution delivery system. Marketed by Exela Pharma Sciences, Llc, this product is identified by NDC 51754-1007 and is authorized under FDA application NDA210660.

Identification & Billing

NDC Package Code
51754-1007-3
Package Description
100 mL in 1 CARTON
Product Code
51754-1007
11-Digit Billing Format
51754100703
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
100 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Elcys
Non-Proprietary Name
Cysteine Hydrochloride
Substance Name
Cysteine Hydrochloride
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)
CYSTEINE HYDROCHLORIDE 10 mg/mL
Usage Information
ELCYS is indicated for use as an additive to amino acid solutions to meet the nutritional requirements of newborn infantsrequiring total parenteral nutrition (TPN) and of adult and pediatric patients with severe liver disease who may haveimpaired enzymatic processes and require TPN. It can also be added to amino acid solutions to provide a more completeprofile of amino acids for protein synthesis.

Regulatory & Marketing

Labeler Name
Exela Pharma Sciences, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA210660
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-28-2019
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (51754-1007). Click a package code to view its specific billing and regulatory data.

51754-1007-1
10 mL in 1 VIAL

* 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 51754-1007-3 identifies a specific commercial package of 100 ml in 1 carton of Elcys, a human prescription drug labeled by Exela Pharma Sciences, Llc. This product is billed per "ML" milliliter and contains an estimated amount of 100 billable units per package. This injection, solution is formulated for intravenous use and contains cysteine hydrochloride 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 Exela Pharma Sciences, Llc on May 28, 2019. The current certification is valid through December 31, 2026.

How is this Exela Pharma Sciences, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51754100703. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 100 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 (5-4-1)
51754-1007-3
11-Digit CMS (5-4-2)
51754-1007-03

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