NDC 54868-5442 Proamatine

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
54868-5442
Proprietary Name:
Proamatine
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Physicians Total Care, Inc.
Labeler Code:
54868
Start Marketing Date: [9]
09-30-2005
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
ORANGE (C48331 - ORANGE)
Shape:
ROUND (C48348)
Size(s):
7 MM
Imprint(s):
RPC;5;004
Score:
2

Product Packages

NDC Code 54868-5442-0

Package Description: 10 TABLET in 1 BOTTLE

NDC Code 54868-5442-1

Package Description: 90 TABLET in 1 BOTTLE

NDC Code 54868-5442-2

Package Description: 60 TABLET in 1 BOTTLE

Product Details

What is NDC 54868-5442?

The NDC code 54868-5442 is assigned by the FDA to the product Proamatine which is product labeled by Physicians Total Care, Inc.. The product's dosage form is . The product is distributed in 3 packages with assigned NDC codes 54868-5442-0 10 tablet in 1 bottle , 54868-5442-1 90 tablet in 1 bottle , 54868-5442-2 60 tablet in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Proamatine?

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.

Which are Proamatine UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Proamatine Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Proamatine?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".