Extraneal Injection, Solution
NDC Package 0941-0679-53

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

Extraneal (icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride) injection is eXTRANEAL (icodextrin) is indicated for a single daily exchange for the long (8- to 16- hour) dwell during continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) for the management of end-stage renal disease. This formulation utilizes a injection, solution delivery system. Marketed by Vantive Us Healthcare Llc, this product is identified by NDC 0941-0679 and is authorized under FDA application NDA021321.

Identification & Billing

NDC Package Code
0941-0679-53
Package Description
2500 mL in 1 BAG
Product Code
0941-0679
11-Digit Billing Format
00941067953
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
2500 ML
RxNorm Crosswalk
  • RxCUI: 1100742 - calcium chloride 0.00232 MEQ/ML / icodextrin 75 MG/ML / magnesium chloride 0.000533 MEQ/ML / sodium chloride 0.0915 MEQ/ML / sodium lactate 0.04 MEQ/ML Injectable Solution
  • RxCUI: 1100742 - Calcium Chloride 0.00232 MEQ/ML / icodextrin 75 MG/ML / Magnesium Chloride 0.000533 MEQ/ML / NaCl 0.0915 MEQ/ML / Sodium Lactate 0.04 MEQ/ML Injectable Solution
  • RxCUI: 1100746 - Extraneal 0.00232 MEQ/mL / 75 MG/mL / 0.000533 MEQ/mL / 0.0915 MEQ/mL / 0.04 MEQ/mL Injectable Solution
  • RxCUI: 1100746 - calcium chloride 0.00232 MEQ/ML / icodextrin 75 MG/ML / magnesium chloride 0.000533 MEQ/ML / sodium chloride 0.0915 MEQ/ML / sodium lactate 0.04 MEQ/ML Injectable Solution [Extraneal]
  • RxCUI: 1100746 - Calcium Chloride 0.00232 MEQ/ML / icodextrin 75 MG/ML / Magnesium Chloride 0.000533 MEQ/ML / NaCl 0.0915 MEQ/ML / Sodium Lactate 0.04 MEQ/ML Injectable Solution [Extraneal]

Clinical Specifications

Proprietary Name
Extraneal
Non-Proprietary Name
Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride
Substance Name
Calcium Chloride; Icodextrin; Magnesium Chloride; Sodium Chloride; Sodium Lactate
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
Intraperitoneal - Administration within the peritoneal cavity.
Active Ingredient(s)
Pharmacologic Class
Usage Information
EXTRANEAL (icodextrin) is indicated for a single daily exchange for the long (8- to 16- hour) dwell during continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) for the management of end-stage renal disease. EXTRANEAL is also indicated to improve (compared to 4.25% dextrose) long-dwell ultrafiltration and clearance of creatinine and urea nitrogen in patients with high average or greater transport characteristics, as defined using the peritoneal equilibration test (PET) [see Clinical Pharmacology (12), Clinical Studies (14)].

Regulatory & Marketing

Labeler Name
Vantive Us Healthcare Llc
Product Type
Human Prescription Drug
FDA Application #
NDA021321
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-20-2002
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 (0941-0679). Click a package code to view its specific billing and regulatory data.

0941-0679-05
2500 mL in 1 BAG
0941-0679-06
2000 mL in 1 BAG
0941-0679-52
2000 mL in 1 BAG

* 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 0941-0679-53 identifies a specific commercial package of 2500 ml in 1 bag of Extraneal, a human prescription drug labeled by Vantive Us Healthcare Llc. This product is billed per "ML" milliliter and contains an estimated amount of 2500 billable units per package. This injection, solution is formulated for intraperitoneal use and contains calcium chloride; icodextrin; magnesium chloride; sodium chloride; sodium lactate 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 Vantive Us Healthcare Llc on December 20, 2002. The current certification is valid through December 31, 2026.

How is this Vantive Us Healthcare Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00941067953. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 2500 total billable units per package. 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)
0941-0679-53
11-Digit CMS (5-4-2)
00941-0679-53

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