Tadalafil Tablet
NDC Package 68071-3545-3

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Tadalafil tablets is tadalafil is used to treat high blood pressure in the lungs (pulmonary hypertension). This formulation utilizes a tablet delivery system. Marketed by Nucare Pharmaceuticals,inc., this product is identified by NDC 68071-3545 and is authorized under FDA application ANDA210609.

Identification & Billing

NDC Package Code
68071-3545-3
Package Description
30 TABLET in 1 BOTTLE
Product Code
68071-3545
11-Digit Billing Format
68071354503
RxNorm Crosswalk
RxCUI: 403957 - tadalafil 5 MG Oral Tablet

Clinical Specifications

Proprietary Name
Tadalafil
Non-Proprietary Name
Tadalafil
Substance Name
Tadalafil
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
TADALAFIL 5 mg/1
Pharmacologic Class
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
Nucare Pharmaceuticals,inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA210609
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-18-2022
Listing Expiration
12-31-2026
Exclude Flag
N
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68071-3545-3 identifies a specific commercial package of 30 tablet in 1 bottle of Tadalafil, a human prescription drug labeled by Nucare Pharmaceuticals,inc.. This tablet is formulated for oral 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 Nucare Pharmaceuticals,inc. on January 18, 2022. 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 Nucare Pharmaceuticals,inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68071354503. 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)
68071-3545-3
11-Digit CMS (5-4-2)
68071-3545-03

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