Tadalafil Tablet, Coated
NDC Package 12579-200-00

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Tadalafil tablets is tadalafil is used to treat high blood pressure in the lungs (pulmonary hypertension). This formulation utilizes a tablet, coated delivery system. Marketed by Opella Healthcare International Sas, this product is identified by NDC 12579-200.

Identification & Billing

NDC Package Code
12579-200-00
Package Description
566667 TABLET, COATED in 1 BAG
Product Code
12579-200
11-Digit Billing Format
12579020000

Clinical Specifications

Proprietary Name
Tadalafil
Non-Proprietary Name
Tadalafil
Substance Name
Tadalafil
Dosage Form
Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
Active Ingredient(s)
TADALAFIL 5 mg/1
Usage Information
Tadalafil is used to treat high blood pressure in the lungs (pulmonary hypertension). It works by relaxing and widening the blood vessels in your lungs which allows the blood to flow more easily. Decreasing high blood pressure in the lungs allows your heart and lungs to work better and improves your ability to exercise.

Regulatory & Marketing

Labeler Name
Opella Healthcare International Sas
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
07-01-2025
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 12579-200-00 identifies a specific commercial package of 566667 tablet, coated in 1 bag of Tadalafil (UNFINISHED drug), drug for further processing labeled by Opella Healthcare International Sas. This tablet, coated is formulated for use and contains tadalafil as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Opella Healthcare International Sas on July 01, 2025. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Tadalafil is used to treat high blood pressure in the lungs (pulmonary hypertension). It works by relaxing and widening the blood vessels in your lungs which allows the blood to flow more easily. Decreasing high blood pressure in the lungs allows your heart and lungs to work better and improves your ability to exercise.

How is this Opella Healthcare International Sas product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 12579020000. 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)
12579-200-00
11-Digit CMS (5-4-2)
12579-0200-00

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