Theratears Gel
NDC Package 58790-003-30

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

Package Information

Theratears (carboxymethylcellulose sodium) gel is a medication used to relieve dry, irritated eyes. This formulation utilizes a gel delivery system. Marketed by Medtech Products Inc, this product is identified by NDC 58790-003 and is authorized under FDA application M018.

Identification & Billing

NDC Package Code
58790-003-30
Package Description
6 POUCH in 1 CARTON / 5 VIAL in 1 POUCH / .6 mL in 1 VIAL
Product Code
58790-003
11-Digit Billing Format
58790000330
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Theratears
Non-Proprietary Name
Carboxymethylcellulose Sodium
Substance Name
Carboxymethylcellulose Sodium, Unspecified Form
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)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 10 mg/mL
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
Medtech Products Inc
Product Type
Human Otc Drug
FDA Application #
M018
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-07-2018
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 58790-003-30 identifies a specific commercial package of 6 pouch in 1 carton / 5 vial in 1 pouch / .6 ml in 1 vial of Theratears, a human over the counter drug labeled by Medtech Products Inc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This gel is formulated for ophthalmic use and contains carboxymethylcellulose sodium, unspecified form 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 Medtech Products Inc on December 07, 2018. 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 Medtech Products Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58790000330. 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 (5-3-2)
58790-003-30
11-Digit CMS (5-4-2)
58790-0003-30

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