NDC Package 58790-007-16 Theratears Extra

Carboxymethylcellulose Sodium,Unspecified Form Solution/ Drops Ophthalmic - View Billable Units, 11-Digit Format, RxNorm

Package Information
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Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

58790-007-16

Package Description:

2 BOTTLE, DROPPER in 1 CARTON / 15 mL in 1 BOTTLE, DROPPER

Product Code:

58790-007

Proprietary Name:

Theratears Extra

Non-Proprietary Name:

Carboxymethylcellulose Sodium, Unspecified Form

Substance Name:

Carboxymethylcellulose Sodium, Unspecified Form

Usage Information:

Instill 1 or 2 drops of TheraTears® Extra in the affected eye(s) as needed.

11-Digit NDC Billing Format:

58790000716

NDC to RxNorm Crosswalk:

RxCUI: 1547948 - carboxymethylcellulose sodium 0.25 % Ophthalmic Solution

RxCUI: 1547948 - carboxymethylcellulose sodium 2.5 MG/ML Ophthalmic Solution

RxCUI: 2106821 - TheraTears 0.25 % Ophthalmic Solution

RxCUI: 2106821 - carboxymethylcellulose sodium 2.5 MG/ML Ophthalmic Solution [TheraTears]

RxCUI: 2106821 - Thera Tears 0.25 % Ophthalmic Solution

Product Type:

Human Otc Drug

Labeler Name:

Medtech Products Inc

Dosage Form:

Solution/ Drops - A solution which is usually administered in a drop-wise fashion.

Administration Route(s):

Ophthalmic - Administration to the external eye.

Active Ingredient(s):

CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 2.5 mg/mL

Sample Package:

FDA Application Number:

part349

Marketing Category:

OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.

Start Marketing Date:

04-16-2018

Listing Expiration Date:

12-31-2024

Exclude Flag:

Code Structure:

58790 - Medtech Products Inc
- 58790-007 - Theratears Extra
  - 58790-007-16 - 2 BOTTLE, DROPPER in 1 CARTON / 15 mL in 1 BOTTLE, DROPPER

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
58790-007-15	1 BOTTLE, DROPPER in 1 CARTON / 15 mL in 1 BOTTLE, DROPPER

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 58790-007-16?

The NDC Packaged Code 58790-007-16 is assigned to a package of 2 bottle, dropper in 1 carton / 15 ml in 1 bottle, dropper of Theratears Extra, a human over the counter drug labeled by Medtech Products Inc. The product's dosage form is solution/ drops and is administered via ophthalmic form.

Is NDC 58790-007 included in the NDC Directory?

Yes, Theratears Extra with product code 58790-007 is active and included in the NDC Directory. The product was first marketed by Medtech Products Inc on April 16, 2018 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 58790-007-16?

The 11-digit format is 58790000716. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	58790-007-16	5-4-2	58790-0007-16

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