NDC Package 54868-5442-1 Proamatine

View Billable Units, 11-Digit Format, RxNorm

Package Information
Other Packages
Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

54868-5442-1

Package Description:

90 TABLET in 1 BOTTLE

Product Code:

54868-5442

Proprietary Name:

Proamatine

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.

11-Digit NDC Billing Format:

54868544201

NDC to RxNorm Crosswalk:

RxCUI: 993470 - midodrine HCl 5 MG Oral Tablet

RxCUI: 993470 - midodrine hydrochloride 5 MG Oral Tablet

RxCUI: 993472 - ProAmatine 5 MG Oral Tablet

RxCUI: 993472 - midodrine hydrochloride 5 MG Oral Tablet [Proamatine]

Labeler Name:

Physicians Total Care, Inc.

Sample Package:

Start Marketing Date:

09-30-2005

Listing Expiration Date:

12-31-2017

Exclude Flag:

Code Structure:

54868 - Physicians Total Care, Inc.
- 54868-5442 - Proamatine
  - 54868-5442-1 - 90 TABLET in 1 BOTTLE

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
54868-5442-0	10 TABLET in 1 BOTTLE
54868-5442-2	60 TABLET in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 54868-5442-1?

The NDC Packaged Code 54868-5442-1 is assigned to a package of 90 tablet in 1 bottle of Proamatine, labeled by Physicians Total Care, Inc.. The product's dosage form is and is administered via form.

Is NDC 54868-5442 included in the NDC Directory?

No, Proamatine with product code 54868-5442 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Physicians Total Care, Inc. on September 30, 2005 and its listing in the NDC Directory is set to expire on December 31, 2017 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 54868-5442-1?

The 11-digit format is 54868544201. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-4-1	54868-5442-1	5-4-2	54868-5442-01

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