Iso-quin
NDC Package 59316-997-50

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Iso-quin is a . Marketed by Performance Health, Llc, this product is identified by NDC 59316-997 and is authorized under FDA application part333E.

Identification & Billing

NDC Package Code
59316-997-50
Package Description
3785 mL in 1 BOTTLE
Product Code
59316-997
11-Digit Billing Format
59316099750

Clinical Specifications

Proprietary Name
Iso-quin
Dosage Form
-

Regulatory & Marketing

Labeler Name
Performance Health, Llc
FDA Application #
part333E
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
05-19-2017
End Marketing Date
12-31-2024
Listing Expiration
12-31-2024
Exclude Flag
D
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (59316-997). Click a package code to view its specific billing and regulatory data.

59316-997-20
118 mL in 1 BOTTLE
59316-997-30
473 mL in 1 BOTTLE

* 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 59316-997-50 identifies a specific commercial package of 3785 ml in 1 bottle of Iso-quin, labeled by Performance Health, Llc. 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 Performance Health, Llc on May 19, 2017. The current certification is valid through December 31, 2024.

How is this Performance Health, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59316099750. 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)
59316-997-50
11-Digit CMS (5-4-2)
59316-0997-50

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