Glycine Irrigant
NDC Package 0990-7974-08

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

Package Information

Glycine irrigants is 1.5% Glycine Irrigation, USP is indicated for use as irrigating fluid during transurethral prostatic resection and other transurethral surgical procedures. This formulation utilizes a irrigant delivery system. Marketed by Icu Medical Inc., this product is identified by NDC 0990-7974 and is authorized under FDA application NDA018315.

Identification & Billing

NDC Package Code
0990-7974-08
Package Description
4 POUCH in 1 CASE / 1 BAG in 1 POUCH / 3000 mL in 1 BAG
Product Code
0990-7974
11-Digit Billing Format
00990797408
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Glycine
Non-Proprietary Name
Glycine
Substance Name
Glycine
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)
GLYCINE 1.5 g/100mL
Usage Information
1.5% Glycine Irrigation, USP is indicated for use as irrigating fluid during transurethral prostatic resection and other transurethral surgical procedures.

Regulatory & Marketing

Labeler Name
Icu Medical Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA018315
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-01-2019
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 0990-7974-08 identifies a specific commercial package of 4 pouch in 1 case / 1 bag in 1 pouch / 3000 ml in 1 bag of Glycine, a human prescription drug labeled by Icu Medical Inc.. This irrigant is formulated for irrigation use and contains glycine 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 Icu Medical Inc. on July 01, 2019. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00990797408. 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)
0990-7974-08
11-Digit CMS (5-4-2)
00990-7974-08

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