Cupric Chloride Injection, Solution
NDC Package 51754-0103-4

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

Cupric Chloride injection is uSP 0.4 mg/mL is indicated for use as a supplement to intravenous solutions given for total parenteral nutrition (TPN). This formulation utilizes a injection, solution delivery system. Marketed by Exela Pharma Sciences, Llc, this product is identified by NDC 51754-0103 and is authorized under FDA application ANDA212071.

Identification & Billing

NDC Package Code
51754-0103-4
Package Description
25 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE
Product Code
51754-0103
11-Digit Billing Format
51754010304
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cupric Chloride
Non-Proprietary Name
Cupric Chloride
Substance Name
Cupric Chloride
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)
CUPRIC CHLORIDE .4 mg/mL
Usage Information
Cupric Chloride Injection, USP 0.4 mg/mL is indicated for use as a supplement to intravenous solutions given for total parenteral nutrition (TPN). Administration helps to maintain copper serum levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.

Regulatory & Marketing

Labeler Name
Exela Pharma Sciences, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA212071
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-01-2023
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 (51754-0103). Click a package code to view its specific billing and regulatory data.

51754-0103-3
10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE

* 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 51754-0103-4 identifies a specific commercial package of 25 vial, single-dose in 1 carton / 10 ml in 1 vial, single-dose of Cupric Chloride, a human prescription drug labeled by Exela Pharma Sciences, Llc. This injection, solution is formulated for intravenous use and contains cupric chloride 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 February 01, 2023. 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: 51754010304. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
51754-0103-4
11-Digit CMS (5-4-2)
51754-0103-04

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