NDC 51862-005 Dofetilide

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:
51862-005
Proprietary Name:
Dofetilide
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Mayne Pharma Inc.
Labeler Code:
51862
Start Marketing Date: [9]
06-07-2016
Listing Expiration Date: [11]
12-31-2023
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
BROWN (C48332 - DARK CARAMEL)
ORANGE (C48331 - LIGHT ORANGE)
Shape:
CAPSULE (C48336)
Size(s):
14 MM
18 MM
Imprint(s):
ML;125
ML;250
ML;500
Score:
1

Product Packages

NDC Code 51862-005-60

Package Description: 60 CAPSULE in 1 BOTTLE, PLASTIC

Price per Unit: $0.53410 per EA

Product Details

What is NDC 51862-005?

The NDC code 51862-005 is assigned by the FDA to the product Dofetilide which is product labeled by Mayne Pharma Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 51862-005-60 60 capsule in 1 bottle, plastic . 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 Dofetilide?

This medication is used to treat certain types of serious (possibly fatal) irregular heartbeat (such as atrial fibrillation/flutter). It is used to restore normal heart rhythm and maintain a regular, steady heartbeat. Dofetilide is known as an anti-arrhythmic drug. It works by blocking the activity of certain electrical signals in the heart that can cause an irregular heartbeat. Treating an irregular heartbeat can decrease the risk for blood clots, and this effect can reduce your risk of heart attack or stroke.

Which are Dofetilide UNII Codes?

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

Which are Dofetilide 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 Dofetilide?

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.

Patient Education

Dofetilide


Dofetilide is used to treat an irregular heartbeat (including atrial fibrillation or atrial flutter). It is in a class of medications called antiarrhythmics. It improves your heart rhythm by relaxing an overactive heart.
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* 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".