Systane Gel
NDC Package 0065-0474-01

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

Package Information

Systane (hypromellose) gel is put 1 or 2 drops in the affected eye(s) as needed put 1 or 2 drops in the affected eye(s) as needed. This formulation utilizes a gel delivery system. Marketed by Alcon Laboratories, Inc., this product is identified by NDC 0065-0474 and is authorized under FDA application M018.

Identification & Billing

NDC Package Code
0065-0474-01
Package Description
1 TUBE in 1 CARTON / 10 g in 1 TUBE
Product Code
0065-0474
11-Digit Billing Format
00065047401
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
10 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Systane
Non-Proprietary Name
Hypromellose
Substance Name
Hypromellose 2910 (4000 Mpa.s)
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
HYPROMELLOSE 2910 (4000 MPA.S) 3 mg/g
Usage Information
Put 1 or 2 drops in the affected eye(s) as needed put 1 or 2 drops in the affected eye(s) as needed

Regulatory & Marketing

Labeler Name
Alcon Laboratories, Inc.
Product Type
Human Otc Drug
FDA Application #
M018
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-15-2012
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0065-0474). Click a package code to view its specific billing and regulatory data.

0065-0474-02
1 TUBE in 1 CARTON / 3.5 g in 1 TUBE

* 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 0065-0474-01 identifies a specific commercial package of 1 tube in 1 carton / 10 g in 1 tube of Systane, a human over the counter drug labeled by Alcon Laboratories, Inc.. This gel is formulated for ophthalmic use and contains hypromellose 2910 (4000 mpa.s) 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 Alcon Laboratories, Inc. on December 15, 2012. The current certification is valid through December 31, 2026.

How is this Alcon Laboratories, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00065047401. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 10 total billable units per package. 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)
0065-0474-01
11-Digit CMS (5-4-2)
00065-0474-01

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