Sterile Water Injection
NDC Package 0404-9971-00

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

Package Information

Sterile Water (water) injection is this parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered. This formulation utilizes a injection delivery system. Marketed by Henry Schein, Inc., this product is identified by NDC 0404-9971 and is authorized under FDA application NDA018801.

Identification & Billing

NDC Package Code
0404-9971-00
Package Description
1 VIAL, GLASS in 1 BAG / 100 mL in 1 VIAL, GLASS
Product Code
0404-9971
11-Digit Billing Format
00404997100

Clinical Specifications

Proprietary Name
Sterile Water
Non-Proprietary Name
Water
Substance Name
Water
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
WATER 1 mL/mL
Usage Information
This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.

Regulatory & Marketing

Labeler Name
Henry Schein, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA018801
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-10-2022
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 0404-9971-00 identifies a specific commercial package of 1 vial, glass in 1 bag / 100 ml in 1 vial, glass of Sterile Water, a human prescription drug labeled by Henry Schein, Inc.. This injection is formulated for intramuscular; intravenous; subcutaneous 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 Henry Schein, Inc. on January 10, 2022. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00404997100. 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)
0404-9971-00
11-Digit CMS (5-4-2)
00404-9971-00

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