Sterile Water Irrigant
NDC Package 0338-0004-04

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. Frequently Asked Questions

Package Information

Sterile Water (water) irrigants is sterile Water for Irrigation is indicated for use as an irrigant. This formulation utilizes a irrigant delivery system. Marketed by Baxter Healthcare Corporation, this product is identified by NDC 0338-0004 and is authorized under FDA application NDA017428.

Identification & Billing

NDC Package Code
0338-0004-04
Package Description
12 BOTTLE, PLASTIC in 1 CARTON / 1000 mL in 1 BOTTLE, PLASTIC
Product Code
0338-0004
11-Digit Billing Format
00338000404
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sterile Water
Non-Proprietary Name
Water
Substance Name
Water
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)
WATER 100 mL/100mL
Usage Information
Sterile Water for Irrigation is indicated for use as an irrigant.

Regulatory & Marketing

Labeler Name
Baxter Healthcare Corporation
Product Type
Human Prescription Drug
FDA Application #
NDA017428
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-31-1974
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

A4217
Source: PDAC
STERILE WATER/SALINE, 500 ML
HCPCS Dosage 500 ML
Units / Pkg

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 (0338-0004). Click a package code to view its specific billing and regulatory data.

0338-0004-02
24 BOTTLE, PLASTIC in 1 CARTON / 250 mL in 1 BOTTLE, PLASTIC
0338-0004-03
18 BOTTLE, PLASTIC in 1 CARTON / 500 mL in 1 BOTTLE, PLASTIC
0338-0004-05
9 BOTTLE, PLASTIC in 1 CARTON / 1500 mL in 1 BOTTLE, PLASTIC

* 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 0338-0004-04 identifies a specific commercial package of 12 bottle, plastic in 1 carton / 1000 ml in 1 bottle, plastic of Sterile Water, a human prescription drug labeled by Baxter Healthcare Corporation. This irrigant is formulated for irrigation use and contains water 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 December 31, 1974. 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: 00338000404. 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)
0338-0004-04
11-Digit CMS (5-4-2)
00338-0004-04

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