Tadalafil Powder
NDC Package 73377-080-04

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 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 powders is tadalafil is used to treat high blood pressure in the lungs (pulmonary hypertension). This formulation utilizes a powder delivery system. Marketed by Ax Pharmaceutical Corp, this product is identified by NDC 73377-080.

Identification & Billing

NDC Package Code
73377-080-04
Package Description
10000 g in 1 JAR
Product Code
73377-080
11-Digit Billing Format
73377008004

Clinical Specifications

Proprietary Name
Tadalafil
Non-Proprietary Name
Tadalafil
Substance Name
Tadalafil
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
TADALAFIL 1 g/g
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
Ax Pharmaceutical Corp
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING - A category specifying that a bulk product is intended for use on humans and requires a prescription.
Start Marketing Date
10-19-2020
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (73377-080). Click a package code to view its specific billing and regulatory data.

73377-080-01
500 g in 1 JAR
73377-080-02
50 g in 1 JAR
73377-080-03
20000 g in 1 JAR
73377-080-05
5000 g in 1 JAR
73377-080-06
85 g in 1 JAR
73377-080-07
82 g in 1 JAR

* 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 73377-080-04 identifies a specific commercial package of 10000 g in 1 jar of Tadalafil (UNFINISHED drug), a bulk ingredient labeled by Ax Pharmaceutical Corp. This powder 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 Ax Pharmaceutical Corp on October 19, 2020. The current certification is valid through December 31, 2027.

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 Ax Pharmaceutical Corp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 73377008004. 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)
73377-080-04
11-Digit CMS (5-4-2)
73377-0080-04

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