Primsol
NDC Package 69654-501-01

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.

Primsol is a . Marketed by Aytu Bioscience, Inc., this product is identified by NDC 69654-501 and is authorized under FDA application NDA074973.

Identification & Billing

NDC Package Code
69654-501-01
Package Description
20 mL in 1 BOTTLE, PLASTIC
Product Code
69654-501
11-Digit Billing Format
69654050101

Clinical Specifications

Proprietary Name
Primsol
Dosage Form
-

Regulatory & Marketing

Labeler Name
Aytu Bioscience, Inc.
FDA Application #
NDA074973
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-15-2015
End Marketing Date
01-01-2018
Listing Expiration
01-01-2018
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 (69654-501). Click a package code to view its specific billing and regulatory data.

69654-501-05
473 mL in 1 BOTTLE, PLASTIC

* 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 69654-501-01 identifies a specific commercial package of 20 ml in 1 bottle, plastic of Primsol, labeled by Aytu Bioscience, 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 Aytu Bioscience, Inc. on September 15, 2015. The current certification is valid through January 01, 2018.

How is this Aytu Bioscience, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69654050101. 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)
69654-501-01
11-Digit CMS (5-4-2)
69654-0501-01

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