Remodulin
NDC Package 66302-112-01

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 EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Remodulin is a medication used to treat a type of high blood pressure in the lungs (pulmonary arterial hypertension). Marketed by United Therapeutics Corporation, this product is identified by NDC 66302-112 and is authorized under FDA application NDA021272.

Identification & Billing

NDC Package Code
66302-112-01
Package Description
1 VIAL in 1 BOX / 20 mL in 1 VIAL
Product Code
66302-112
11-Digit Billing Format
66302011201
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Remodulin
Dosage Form
-
Usage Information
This medication is used to treat a type of high blood pressure in the lungs (pulmonary arterial hypertension). Treprostinil helps to improve symptoms such as shortness of breath and tiredness. It works by relaxing and widening the blood vessels (arteries) in the lungs and other parts of the body so that blood can flow more easily. This medication belongs to a class of drugs known as vasodilators.

Regulatory & Marketing

Labeler Name
United Therapeutics Corporation
FDA Application #
NDA021272
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-28-2023
End Marketing Date
03-26-2024
Listing Expiration
03-26-2024
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 66302-112-01 identifies a specific commercial package of 1 vial in 1 box / 20 ml in 1 vial of Remodulin, labeled by United Therapeutics Corporation. 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 United Therapeutics Corporation on September 28, 2023. The current certification is valid through March 26, 2024.

What are the primary indications for this medication?

This medication is used to treat a type of high blood pressure in the lungs (pulmonary arterial hypertension). Treprostinil helps to improve symptoms such as shortness of breath and tiredness. It works by relaxing and widening the blood vessels (arteries) in the lungs and other parts of the body so that blood can flow more easily. This medication belongs to a class of drugs known as vasodilators.

How is this United Therapeutics Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 66302011201. 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)
66302-112-01
11-Digit CMS (5-4-2)
66302-0112-01

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