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  4. NDC Product Code: 54868-5950 Propafenone Hydrochloride

NDC 54868-5950 Propafenone Hydrochloride

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 54868-5950?
  5. Propafenone Hydrochloride Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
54868-5950
Proprietary Name:
Propafenone Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Physicians Total Care, Inc.
Labeler Code:
54868
Product Label ID:
a7c8f090-c48c-44f7-9973-2cf4b491e35c
Start Marketing Date: [9]
10-09-2008
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
ROUND (C48348)
Size(s):
9 MM
10 MM
Imprint(s):
MP;511
MP;512
Score:
2

Product Packages

NDC Code 54868-5950-0

Package Description: 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

NDC Code 54868-5950-1

Package Description: 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

NDC Code 54868-5950-2

Package Description: 60 TABLET, FILM COATED in 1 BOTTLE

Product Details

What is NDC 54868-5950?

The NDC code 54868-5950 is assigned by the FDA to the product Propafenone Hydrochloride 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 54868-5950-0 90 tablet, film coated in 1 bottle, plastic , 54868-5950-1 30 tablet, film coated in 1 bottle, plastic , 54868-5950-2 60 tablet, film coated 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 Propafenone Hydrochloride?

In patients without structural heart disease, propafenone is indicated to prolong the time to recurrence of–paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms.–paroxysmal supraventricular tachycardia (PSVT) associated with disabling symptoms.As with other agents, some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase in ventricular rate. Concomitant treatment with drugs that increase the functional AV refractory period is recommended.The use of propafenone HCl in patients with chronic atrial fibrillation has not been evaluated. Propafenone HCl should not be used to control ventricular rate during atrial fibrillation.Propafenone HCl is also indicated for the treatment of–documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of propafenone HCl, its use with lesser ventricular arrhythmias is not recommended, even if patients are symptomatic, and any use of the drug should be reserved for patients in whom, in the opinion of the physician, the potential benefits outweigh the risks.Initiation of propafenone HCl treatment, as with other antiarrhythmics used to treat life-threatening ventricular arrhythmias, should be carried out in the hospital.Propafenone HCl, like other antiarrhythmic drugs, has not been shown to enhance survival in patients with ventricular or atrial arrhythmias.

Which are Propafenone Hydrochloride UNII Codes?

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

Which are Propafenone Hydrochloride 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 Propafenone Hydrochloride?

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:

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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".