Tis-u-sol Irrigant
NDC Package 0338-0190-04

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

Package Information

Tis-u-sol (sodium chloride, potassium chloride, magnesium sulfate, sodium phosphate, and potassium phosphate) irrigants is isotonic solution for irrigation only. This formulation utilizes a irrigant delivery system. Marketed by Baxter Healthcare Corporation, this product is identified by NDC 0338-0190 and is authorized under FDA application NDA018508.

Identification & Billing

NDC Package Code
0338-0190-04
Package Description
12 BOTTLE, PLASTIC in 1 CARTON / 1000 mL in 1 BOTTLE, PLASTIC
Product Code
0338-0190
11-Digit Billing Format
00338019004
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 801442 - magnesium sulfate 0.2 MG/mL / monobasic K+ phosphate 0.063 MG/mL / K+ chloride 0.005 MEQ/mL / NaCl 0.14 MEQ/mL / sodium phosphate dihydrate 0.088 MG/mL Irrigation Solution
  • RxCUI: 801442 - magnesium sulfate 0.2 MG/ML / monobasic potassium phosphate 0.063 MG/ML / potassium chloride 0.005 MEQ/ML / sodium chloride 0.14 MEQ/ML / sodium phosphate dihydrate 0.088 MG/ML Irrigation Solution
  • RxCUI: 801442 - Magnesium Sulfate 0.2 MG/ML / Monobasic K+ phosphate 0.063 MG/ML / K+ Chloride 0.005 MEQ/ML / NaCl 0.14 MEQ/ML / SODIUM PHOSPHATE DIHYDRATE 0.088 MG/ML Irrigation Solution
  • RxCUI: 801442 - Magnesium Sulfate 0.2 MG/ML / Monobasic Pot phosphate 0.063 MG/ML / Pot Chloride 0.005 MEQ/ML / NaCl 0.14 MEQ/ML / SODIUM PHOSPHATE DIHYDRATE 0.088 MG/ML Irrigation Solution
  • RxCUI: 801445 - Tis-U-Sol 20 MG / 6.25 MG / 40 MG / 800 MG / 8.75 MG in 100 mL Irrigation Solution

Clinical Specifications

Proprietary Name
Tis-u-sol
Non-Proprietary Name
Sodium Chloride, Potassium Chloride, Magnesium Sulfate, Sodium Phosphate, And Potassium Phosphate
Substance Name
Magnesium Sulfate Heptahydrate; Monobasic Potassium Phosphate; Potassium Chloride; Sodium Chloride; Sodium Phosphate, Dibasic, Heptahydrate
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
Isotonic solution for irrigation only. Not for injection.

Regulatory & Marketing

Labeler Name
Baxter Healthcare Corporation
Product Type
Human Prescription Drug
FDA Application #
NDA018508
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-19-1982
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 0338-0190-04 identifies a specific commercial package of 12 bottle, plastic in 1 carton / 1000 ml in 1 bottle, plastic of Tis-u-sol, a human prescription drug labeled by Baxter Healthcare Corporation. This irrigant is formulated for irrigation use and contains magnesium sulfate heptahydrate; monobasic potassium phosphate; potassium chloride; sodium chloride; sodium phosphate, dibasic, heptahydrate 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 Baxter Healthcare Corporation on February 19, 1982. The current certification is valid through December 31, 2027.

How is this Baxter Healthcare Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00338019004. 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)
0338-0190-04
11-Digit CMS (5-4-2)
00338-0190-04

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