Solodyn
NDC Package 67209-0465-3

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.

Solodyn is a medication used to treat moderate to severe acne in people 12 years and older. Marketed by Wellspring Pharmaceutical Canada Corp, this product is identified by NDC 67209-0465 and is authorized under FDA application NDA050808.

Identification & Billing

NDC Package Code
67209-0465-3
Package Description
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code
67209-0465
11-Digit Billing Format
67209046503

Clinical Specifications

Proprietary Name
Solodyn
Dosage Form
-
Usage Information
This medication is used to treat moderate to severe acne in people 12 years and older. It helps to reduce the number of pimples. Minocycline belongs to a class of drugs known as tetracycline antibiotics. It works by stopping the growth of bacteria that may make acne worse. This antibiotic treats acne that is thought to be caused by a bacterial infection. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

Regulatory & Marketing

Labeler Name
Wellspring Pharmaceutical Canada Corp
FDA Application #
NDA050808
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-27-2010
End Marketing Date
08-28-2012
Listing Expiration
08-28-2012
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 (67209-0465). Click a package code to view its specific billing and regulatory data.

67209-0465-1
20 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

* 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 67209-0465-3 identifies a specific commercial package of 30 tablet, film coated, extended release in 1 bottle of Solodyn, labeled by Wellspring Pharmaceutical Canada Corp. 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 Wellspring Pharmaceutical Canada Corp on September 27, 2010. The current certification is valid through August 28, 2012.

What are the primary indications for this medication?

This medication is used to treat moderate to severe acne in people 12 years and older. It helps to reduce the number of pimples. Minocycline belongs to a class of drugs known as tetracycline antibiotics. It works by stopping the growth of bacteria that may make acne worse. This antibiotic treats acne that is thought to be caused by a bacterial infection. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

How is this Wellspring Pharmaceutical Canada Corp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67209046503. 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)
67209-0465-3
11-Digit CMS (5-4-2)
67209-0465-03

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