Genteal Tears Moderate Preservative Free Solution/ Drops
NDC Package 0065-8063-01

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

Package Information

Genteal Tears Moderate Preservative Free (dextran 70, hypromellose 2910) solution/ dropses is put 1 or 2 drops in the affected eye(s) as needed. This formulation utilizes a solution/ drops delivery system. Marketed by Alcon Laboratories, Inc., this product is identified by NDC 0065-8063 and is authorized under FDA application M018.

Identification & Billing

NDC Package Code
0065-8063-01
Package Description
36 VIAL, SINGLE-DOSE in 1 CARTON / .9 mL in 1 VIAL, SINGLE-DOSE
Product Code
0065-8063
11-Digit Billing Format
00065806301
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • RxCUI: 309714 - dextran 70 0.1 % / hypromellose 0.3 % Ophthalmic Solution
  • RxCUI: 309714 - dextran 70 1 MG/ML / hypromellose 3 MG/ML Ophthalmic Solution
  • RxCUI: 309714 - dextran 70 0.1 % / hypromellose 0.3 % Ophthalmic Drops

Clinical Specifications

Proprietary Name
Genteal Tears Moderate Preservative Free
Non-Proprietary Name
Dextran 70, Hypromellose 2910
Substance Name
Dextran 70; Hypromellose 2910 (4000 Mpa.s)
Dosage Form
Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
Pharmacologic Class
Usage Information
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
07-03-2018
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 0065-8063-01 identifies a specific commercial package of 36 vial, single-dose in 1 carton / .9 ml in 1 vial, single-dose of Genteal Tears Moderate Preservative Free, a human over the counter drug labeled by Alcon Laboratories, Inc.. This solution/ drops is formulated for ophthalmic use and contains dextran 70; 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 July 03, 2018. 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: 00065806301. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
0065-8063-01
11-Digit CMS (5-4-2)
00065-8063-01

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