Edetate Calcium Disodium Injection
NDC Package 64980-588-51

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

Package Information

Edetate Calcium Disodium injection is indicated for the reduction of blood levels and depot stores of lead in lead poisoning (acute and chronic) and lead encephalopathy, in both pediatric populations and adults. This formulation utilizes a injection delivery system. Marketed by Rising Pharma Holdings, Inc., this product is identified by NDC 64980-588 and is authorized under FDA application ANDA216435.

Identification & Billing

NDC Package Code
64980-588-51
Package Description
5 VIAL in 1 CARTON / 5 mL in 1 VIAL (64980-588-05)
Product Code
64980-588
11-Digit Billing Format
64980058851
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 847703 - edetate calcium disodium 1000 MG in 5 ML Injection
  • RxCUI: 847703 - 5 ML edetate calcium disodium 200 MG/ML Injection
  • RxCUI: 847703 - edetate calcium disodium 1000 MG per 5 ML Injection

Clinical Specifications

Proprietary Name
Edetate Calcium Disodium
Non-Proprietary Name
Edetate Calcium Disodium
Substance Name
Edetate Calcium Disodium
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
EDETATE CALCIUM DISODIUM 200 mg/mL
Pharmacologic Class
Usage Information
Edetate calcium disodium injection is indicated for the reduction of blood levels and depot stores of lead in lead poisoning (acute and chronic) and lead encephalopathy, in both pediatric populations and adults. Chelation therapy should not replace effective measures to eliminate or reduce further exposure to lead.

Regulatory & Marketing

Labeler Name
Rising Pharma Holdings, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA216435
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-03-2023
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 64980-588-51 identifies a specific commercial package of 5 vial in 1 carton / 5 ml in 1 vial (64980-588-05) of Edetate Calcium Disodium, a human prescription drug labeled by Rising Pharma Holdings, Inc.. This injection is formulated for intramuscular; intravenous use and contains edetate calcium disodium 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 Rising Pharma Holdings, Inc. on May 03, 2023. The current certification is valid through December 31, 2026.

How is this Rising Pharma Holdings, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64980058851. 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)
64980-588-51
11-Digit CMS (5-4-2)
64980-0588-51

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