Proamatine
NDC Package 54868-5442-2

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.

Proamatine is ® is indicated for the treatment of symptomatic orthostatic hypotension (OH). Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-5442 and is authorized under FDA application NDA019815.

Identification & Billing

NDC Package Code
54868-5442-2
Package Description
60 TABLET in 1 BOTTLE
Product Code
54868-5442
11-Digit Billing Format
54868544202
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Proamatine
Dosage Form
-
Usage Information
ProAmatine® is indicated for the treatment of symptomatic orthostatic hypotension (OH). Because ProAmatine® can cause marked elevation of supine blood pressure (BP>200 mmHg systolic), it should be used in patients whose lives are considerably impaired despite standard clinical care, including non-pharmacologic treatment (such as support stockings), fluid expansion, and lifestyle alterations. The indication is based on ProAmatine®'s effect on increases in 1-minute standing systolic blood pressure, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of ProAmatine®, principally improved ability to perform life activities, have not been established. Further clinical trials are underway to verify and describe the clinical benefits of ProAmatine®.After initiation of treatment, ProAmatine® should be continued only for patients who report significant symptomatic improvement.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
NDA019815
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-30-2005
Listing Expiration
12-31-2017
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 (54868-5442). Click a package code to view its specific billing and regulatory data.

54868-5442-0
10 TABLET in 1 BOTTLE
54868-5442-1
90 TABLET 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 54868-5442-2 identifies a specific commercial package of 60 tablet in 1 bottle of Proamatine, labeled by Physicians Total Care, Inc.. 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 Physicians Total Care, Inc. on September 30, 2005. The current certification is valid through December 31, 2017.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868544202. 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)
54868-5442-2
11-Digit CMS (5-4-2)
54868-5442-02

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