Soundbody Artificial Tears
NDC Package 67510-0650-5

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.

Soundbody Artificial Tears is put 1 to 2 drops in the affected eye(s) up to 4 times dailychildren under 6 years of age: ask a doctor. Marketed by Kareway Product, Inc., this product is identified by NDC 67510-0650 and is authorized under FDA application part349.

Identification & Billing

NDC Package Code
67510-0650-5
Package Description
1 BOTTLE in 1 BOX / 15 mL in 1 BOTTLE
Product Code
67510-0650
11-Digit Billing Format
67510065005
RxNorm Crosswalk
  • RxCUI: 259581 - glycerin 0.2 % / hypromellose 0.2 % / polyethylene glycol 400 1 % Ophthalmic Solution
  • RxCUI: 259581 - glycerin 2 MG/ML / hypromellose 2 MG/ML / polyethylene glycol 400 10 MG/ML Ophthalmic Solution
  • RxCUI: 259581 - glycerin 0.2 % / hypromellose 0.2 % / PEG 400 1 % Ophthalmic Solution

Clinical Specifications

Proprietary Name
Soundbody Artificial Tears
Dosage Form
-
Usage Information
Put 1 to 2 drops in the affected eye(s) up to 4 times dailychildren under 6 years of age: ask a doctor

Regulatory & Marketing

Labeler Name
Kareway Product, Inc.
FDA Application #
part349
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
05-30-2018
Listing Expiration
12-31-2019
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 67510-0650-5 identifies a specific commercial package of 1 bottle in 1 box / 15 ml in 1 bottle of Soundbody Artificial Tears, labeled by Kareway Product, Inc.. 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 Kareway Product, Inc. on May 30, 2018. The current certification is valid through December 31, 2019.

How is this Kareway Product, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67510065005. 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 (5-4-1)
67510-0650-5
11-Digit CMS (5-4-2)
67510-0650-05

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