NDC Package 51754-1007-3 Elcys

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

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:
51754-1007-3
Package Description:
100 mL in 1 CARTON
Product Code:
Proprietary Name:
Elcys
Non-Proprietary Name:
Cysteine Hydrochloride
Substance Name:
Cysteine Hydrochloride
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.
11-Digit NDC Billing Format:
51754100703
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
100 ML
NDC to RxNorm Crosswalk:
  • RxCUI: 1667993 - cysteine HCl 0.5 GM in 10 ML (50 MG/ML) Injection
  • RxCUI: 1667993 - 10 ML cysteine hydrochloride 50 MG/ML Injection
  • RxCUI: 1667993 - cysteine HCl 0.5 GM per 10 ML Injection
  • RxCUI: 2169281 - ELCYS 500 MG in 10 ML Injection
  • RxCUI: 2169281 - 10 ML cysteine hydrochloride 50 MG/ML Injection [Elcys]
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Exela Pharma Sciences, Llc
    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):
    Sample Package:
    No
    FDA Application Number:
    NDA210660
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    05-28-2019
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    51754-1007-110 mL in 1 VIAL

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 51754-1007-3?

    The NDC Packaged Code 51754-1007-3 is assigned to a package of 100 ml in 1 carton of Elcys, a human prescription drug labeled by Exela Pharma Sciences, Llc. The product's dosage form is injection, solution and is administered via intravenous form.This product is billed per "ML" milliliter and contains an estimated amount of 100 billable units per package.

    Is NDC 51754-1007 included in the NDC Directory?

    Yes, Elcys with product code 51754-1007 is active and included in the NDC Directory. The product was first marketed by Exela Pharma Sciences, Llc on May 28, 2019 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 51754-1007-3?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 100.

    What is the 11-digit format for NDC 51754-1007-3?

    The 11-digit format is 51754100703. 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 5-4-1 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
    5-4-151754-1007-35-4-251754-1007-03