Artificial Tears
NDC Package 13985-600-03

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Artificial Tears is a medication used to relieve dry, irritated eyes. Marketed by Mwi, this product is identified by NDC 13985-600 and is authorized under FDA application part349.

Identification & Billing

NDC Package Code
13985-600-03
Package Description
1 TUBE in 1 CARTON / 3.5 g in 1 TUBE
Product Code
13985-600
11-Digit Billing Format
13985060003
RxNorm Crosswalk
  • RxCUI: 746083 - mineral oil 15 % / petrolatum 83 % Ophthalmic Ointment
  • RxCUI: 746083 - mineral oil 0.15 MG/MG / petrolatum 0.83 MG/MG Ophthalmic Ointment
  • RxCUI: 746083 - mineral oil 15 % / petrolatum, white 83 % Ophthalmic Ointment

Clinical Specifications

Proprietary Name
Artificial Tears
Dosage Form
-
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
Mwi
FDA Application #
part349
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
03-23-2015
Listing Expiration
12-31-2023
Exclude Flag
I
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 13985-600-03 identifies a specific commercial package of 1 tube in 1 carton / 3.5 g in 1 tube of Artificial Tears, labeled by Mwi. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Mwi on March 23, 2015. The current certification is valid through December 31, 2023.

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 Mwi product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 13985060003. 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)
13985-600-03
11-Digit CMS (5-4-2)
13985-0600-03

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