Physiolyte Irrigant
NDC Package 0264-2205-00

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

Package Information

Physiolyte (sodium chloride, sodium gluconate, sodium acetate, potassium chloride, and magnesium chloride) irrigants is physiolyte™ (A Physiological Irrigating Solution) is indicated for all general irrigation, washing, and rinsing purposes which permit use of a sterile, nonpyrogenic electrolyte solution. This formulation utilizes a irrigant delivery system. Marketed by B. Braun Medical Inc., this product is identified by NDC 0264-2205 and is authorized under FDA application NDA019024.

Identification & Billing

NDC Package Code
0264-2205-00
Package Description
16 CONTAINER in 1 CASE / 1000 mL in 1 CONTAINER
Product Code
0264-2205
11-Digit Billing Format
00264220500
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 827351 - magnesium chloride 0.03 GM / potassium chloride 0.037 GM / sodium acetate 0.37 GM / sodium chloride 0.53 GM / sodium gluconate 0.5 GM in 100 mL Irrigation Solution
  • RxCUI: 827351 - magnesium chloride 0.00148 MEQ/ML / potassium chloride 0.005 MEQ/ML / sodium acetate 0.027 MEQ/ML / sodium chloride 0.09 MEQ/ML / sodium gluconate 0.023 MEQ/ML Irrigation Solution
  • RxCUI: 827351 - Magnesium Chloride 0.00148 MEQ/ML / K+ Chloride 0.005 MEQ/ML / Sodium Acetate 0.027 MEQ/ML / NaCl 0.09 MEQ/ML / Sodium gluconate 0.023 MEQ/ML Irrigation Solution
  • RxCUI: 827351 - Magnesium Chloride 0.00148 MEQ/ML / Pot Chloride 0.005 MEQ/ML / Sodium Acetate 0.027 MEQ/ML / NaCl 0.09 MEQ/ML / Sodium gluconate 0.023 MEQ/ML Irrigation Solution
  • RxCUI: 827351 - magnesium chloride 0.03 GM / potassium chloride 0.037 GM / sodium acetate 0.37 GM / sodium chloride 0.53 GM / sodium gluconate 0.5 GM per 100 ML Irrigation Solution

Clinical Specifications

Proprietary Name
Physiolyte
Non-Proprietary Name
Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, And Magnesium Chloride
Substance Name
Magnesium Chloride; Potassium Chloride; Sodium Acetate; Sodium Chloride; Sodium Gluconate
Dosage Form
Irrigant - A sterile solution intended to bathe or flush open wounds or body cavities; they're used topically, never parenterally.
Administration Route
Irrigation - Administration to bathe or flush open wounds or body cavities.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Physiolyte™ (A Physiological Irrigating Solution) is indicated for all general irrigation, washing, and rinsing purposes which permit use of a sterile, nonpyrogenic electrolyte solution.

Regulatory & Marketing

Labeler Name
B. Braun Medical Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA019024
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-08-1984
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 0264-2205-00 identifies a specific commercial package of 16 container in 1 case / 1000 ml in 1 container of Physiolyte, a human prescription drug labeled by B. Braun Medical Inc.. This irrigant is formulated for irrigation use and contains magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium 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 B. Braun Medical Inc. on June 08, 1984. The current certification is valid through December 31, 2026.

How is this B. Braun Medical Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00264220500. 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)
0264-2205-00
11-Digit CMS (5-4-2)
00264-2205-00

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