Theratears Extra Solution/ Drops
NDC Package 58790-010-30

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

Package Information

Theratears Extra (carboxymethylcellulose sodium, unspecified) solution/ dropses is to open, twist tab completely off. This formulation utilizes a solution/ drops delivery system. Marketed by Medtech Products Inc, this product is identified by NDC 58790-010 and is authorized under FDA application M018.

Identification & Billing

NDC Package Code
58790-010-30
Package Description
6 POUCH in 1 CARTON / 5 VIAL, SINGLE-USE in 1 POUCH / .6 mL in 1 VIAL, SINGLE-USE
Product Code
58790-010
11-Digit Billing Format
58790001030
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 Extra
Non-Proprietary Name
Carboxymethylcellulose Sodium, Unspecified
Substance Name
Carboxymethylcellulose Sodium, Unspecified
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)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED 2.5 mg/mL
Usage Information
To open, twist tab completely off. Instill 1 or 2 drops of TheraTears® EXTRA® in the affected eye(s) as needed

Regulatory & Marketing

Labeler Name
Medtech Products Inc
Product Type
Human Otc Drug
FDA Application #
M018
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-21-2021
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 58790-010-30 identifies a specific commercial package of 6 pouch in 1 carton / 5 vial, single-use in 1 pouch / .6 ml in 1 vial, single-use of Theratears Extra, 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 solution/ drops is formulated for ophthalmic use and contains carboxymethylcellulose sodium, unspecified 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 January 21, 2021. The current certification is valid through December 31, 2026.

How is this Medtech Products Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58790001030. 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)
58790-010-30
11-Digit CMS (5-4-2)
58790-0010-30

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