Plegisol Injection, Solution
NDC Package 0409-7969-05

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

Package Information

Plegisol (potassium chloride, sodium chloride, calcium chloride, and magnesium chloride) injection is plegisol (Cardioplegic Solution) when suitably buffered in combination with ischemia and hypothermia is used to induce cardiac arrest during open heart surgery. This formulation utilizes a injection, solution delivery system. Marketed by Hospira, Inc., this product is identified by NDC 0409-7969 and is authorized under FDA application NDA018608.

Identification & Billing

NDC Package Code
0409-7969-05
Package Description
12 POUCH in 1 CASE / 1 BAG in 1 POUCH / 1000 mL in 1 BAG (0409-7969-11)
Product Code
0409-7969
11-Digit Billing Format
00409796905
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Plegisol
Non-Proprietary Name
Potassium Chloride, Sodium Chloride, Calcium Chloride, And Magnesium Chloride
Substance Name
Calcium Chloride; Magnesium Chloride; Potassium Chloride; Sodium 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
Intra-arterial - Administration within an artery or arteries.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Plegisol (Cardioplegic Solution) when suitably buffered in combination with ischemia and hypothermia is used to induce cardiac arrest during open heart surgery.

Regulatory & Marketing

Labeler Name
Hospira, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA018608
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-28-2005
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 0409-7969-05 identifies a specific commercial package of 12 pouch in 1 case / 1 bag in 1 pouch / 1000 ml in 1 bag (0409-7969-11) of Plegisol, a human prescription drug labeled by Hospira, Inc.. This injection, solution is formulated for intra-arterial use and contains calcium chloride; magnesium chloride; potassium chloride; sodium 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 Hospira, Inc. on July 28, 2005. The current certification is valid through December 31, 2027.

How is this Hospira, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00409796905. 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 (4-4-2)
0409-7969-05
11-Digit CMS (5-4-2)
00409-7969-05

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