Tadalafil
NDC Package 50436-7010-2

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 inactivated by the FDA.

Tadalafil is used to treat high blood pressure in the lungs (pulmonary hypertension). Marketed by Unit Dose Services, this product is identified by NDC 50436-7010 and is authorized under FDA application NDA021368.

Identification & Billing

NDC Package Code
50436-7010-2
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
50436-7010
11-Digit Billing Format
50436701002
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tadalafil
Dosage Form
-
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
Unit Dose Services
FDA Application #
NDA021368
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
09-27-2018
Listing Expiration
12-31-2020
Exclude Flag
I
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 (50436-7010). Click a package code to view its specific billing and regulatory data.

50436-7010-1
200 POUCH in 1 CASE / 1 TABLET, FILM COATED in 1 POUCH
50436-7010-3
90 TABLET, FILM COATED 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 50436-7010-2 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Tadalafil, labeled by Unit Dose Services. 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 Unit Dose Services on September 27, 2018. The current certification is valid through December 31, 2020.

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 Unit Dose Services product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50436701002. 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)
50436-7010-2
11-Digit CMS (5-4-2)
50436-7010-02

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