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  5. NDC Package Code: 65219-497-20 Sterile Water

NDC Package 65219-497-20 Sterile Water

Water Injection Irrigation - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
65219-497-20
Package Description:
5 BAG in 1 CASE / 2000 mL in 1 BAG (65219-497-02)
Product Code:
65219-497
Proprietary Name:
Sterile Water
Non-Proprietary Name:
Water
Substance Name:
Water
Usage Information:
Sterile Water for Irrigation is indicated for use as an irrigating fluid or pharmaceutic aid. Sterile Water may also be used as an adjunct in the preparation of non-intravenously administered nutrient mixtures (see DOSAGE AND ADMINISTRATION).
11-Digit NDC Billing Format:
65219049720
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Fresenius Kabi Usa, Llc
Dosage Form:
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s):
Irrigation - Administration to bathe or flush open wounds or body cavities.
Active Ingredient(s):
WATER 1 mL/mL
Sample Package:
No
FDA Application Number:
ANDA216123
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
08-12-2024
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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 disclaimer below.

Frequently Asked Questions

What is NDC 65219-497-20?

The NDC Packaged Code 65219-497-20 is assigned to a package of 5 bag in 1 case / 2000 ml in 1 bag (65219-497-02) of Sterile Water, a human prescription drug labeled by Fresenius Kabi Usa, Llc. The product's dosage form is injection and is administered via irrigation form.

Is NDC 65219-497 included in the NDC Directory?

Yes, Sterile Water with product code 65219-497 is active and included in the NDC Directory. The product was first marketed by Fresenius Kabi Usa, Llc on August 12, 2024 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 65219-497-20?

The 11-digit format is 65219049720. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-265219-497-205-4-265219-0497-20