Calcium Gluconate Injection, Solution
NDC Package 44567-623-10

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Calcium Gluconate injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia.Limitations of UseThe safety of Calcium Gluconate Injection for long term use has not been established. This formulation utilizes a injection, solution delivery system. Marketed by Wg Critical Care, Llc, this product is identified by NDC 44567-623 and is authorized under FDA application NDA210906.

Identification & Billing

NDC Package Code
44567-623-10
Package Description
10 POUCH in 1 CARTON / 1 BAG in 1 POUCH (44567-623-01) / 100 mL in 1 BAG
Product Code
44567-623
11-Digit Billing Format
44567062310
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Calcium Gluconate
Non-Proprietary Name
Calcium Gluconate
Substance Name
Calcium Gluconate
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)
CALCIUM GLUCONATE 100 mg/mL
Pharmacologic Class
Usage Information
Calcium Gluconate Injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia.Limitations of UseThe safety of Calcium Gluconate Injection for long term use has not been established.

Regulatory & Marketing

Labeler Name
Wg Critical Care, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA210906
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-26-2018
Listing Expiration
12-31-2027
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 44567-623-10 identifies a specific commercial package of 10 pouch in 1 carton / 1 bag in 1 pouch (44567-623-01) / 100 ml in 1 bag of Calcium Gluconate, a human prescription drug labeled by Wg Critical Care, Llc. This injection, solution is formulated for intravenous use and contains calcium gluconate 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 Wg Critical Care, Llc on October 26, 2018. The current certification is valid through December 31, 2027.

How is this Wg Critical Care, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 44567062310. 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 (5-3-2)
44567-623-10
11-Digit CMS (5-4-2)
44567-0623-10

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