Artificial Tears Solution/ Drops
NDC Package 50268-043-15

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

Package Information

Artificial Tears solution/ dropses is a medication used to relieve dry, irritated eyes. This formulation utilizes a solution/ drops delivery system. Marketed by Avpak, this product is identified by NDC 50268-043 and is authorized under FDA application M018.

Identification & Billing

NDC Package Code
50268-043-15
Package Description
15 mL in 1 BOTTLE
Product Code
50268-043
11-Digit Billing Format
50268004315
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
15 ML
RxNorm Crosswalk
  • RxCUI: 900138 - dextran 70 0.1 % / glycerin 0.2 % / hypromellose 0.3 % Ophthalmic Solution
  • RxCUI: 900138 - dextran 70 1 MG/ML / glycerin 2 MG/ML / hypromellose 3 MG/ML Ophthalmic Solution

Clinical Specifications

Proprietary Name
Artificial Tears
Non-Proprietary Name
Artificial Tears
Substance Name
Dextran 70; Glycerin; Hypromelloses
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
This medication is used to relieve dry, irritated eyes. Common causes for dry eyes include wind, sun, heating/air conditioning, computer use/reading, and certain medications. This product may contain 1 or more of the following ingredients: carboxymethylcellulose, dextran, glycerin, hypromellose, polyethylene glycol 400 (PEG 400), polysorbate, polyvinyl alcohol, povidone, or propylene glycol, among others. Eye lubricants keep the eye moist, help to protect the eye from injury and infection, and decrease symptoms of dry eyes such as burning, itching, and feeling as if something is in the eye.

Regulatory & Marketing

Labeler Name
Avpak
Product Type
Human Otc Drug
FDA Application #
M018
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-05-2023
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 50268-043-15 identifies a specific commercial package of 15 ml in 1 bottle of Artificial Tears, a human over the counter drug labeled by Avpak. This solution/ drops is formulated for ophthalmic use and contains dextran 70; glycerin; hypromelloses 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 Avpak on January 05, 2023. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to relieve dry, irritated eyes. Common causes for dry eyes include wind, sun, heating/air conditioning, computer use/reading, and certain medications. This product may contain 1 or more of the following ingredients: carboxymethylcellulose, dextran, glycerin, hypromellose, polyethylene glycol 400 (PEG 400), polysorbate, polyvinyl alcohol, povidone, or propylene glycol, among others. Eye lubricants keep the eye moist, help to protect the eye from injury and infection, and decrease symptoms of dry eyes such as burning, itching, and feeling as if something is in the eye.

How is this Avpak product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50268004315. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 15 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 (5-3-2)
50268-043-15
11-Digit CMS (5-4-2)
50268-0043-15

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