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  4. NDC Product Code: 54868-4063 Coumadin

NDC 54868-4063 Coumadin

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 54868-4063?
  5. Coumadin 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 .
NDC Product Code:
54868-4063
Proprietary Name:
Coumadin
Product Type: [3]
Labeler Name: [5]
Physicians Total Care, Inc.
Labeler Code:
54868
Product Label ID:
91fa852c-b43d-4a55-983b-74aa6827125d
FDA Application Number: [6]
NDA009218
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
11-10-2005
End Marketing Date: [10]
06-30-2010
Listing Expiration Date: [11]
06-30-2010
Exclude Flag: [12]
D
Code Navigator:

Product Characteristics

Color(s):
PINK (C48328)
PURPLE (C48327 - LAVENDER)
GREEN (C48329)
BROWN (C48332 - TAN)
Shape:
ROUND (C48348)
Size(s):
9 MM
Imprint(s):
1;COUMADIN
2;COUMADIN
2;1;2;COUMADIN
3;COUMADIN
Score:
2

Code Structure Chart

Product Details

What is NDC 54868-4063?

The NDC code 54868-4063 is assigned by the FDA to the product Coumadin which is product labeled by Physicians Total Care, Inc.. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 54868-4063-0 30 tablet in 1 bottle , 54868-4063-1 10 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 Coumadin?

This medication is used to treat blood clots (such as in deep vein thrombosis-DVT or pulmonary embolus-PE) and/or to prevent new clots from forming in your body. Preventing harmful blood clots helps to reduce the risk of a stroke or heart attack. Conditions that increase your risk of developing blood clots include a certain type of irregular heart rhythm (atrial fibrillation), heart valve replacement, recent heart attack, and certain surgeries (such as hip/knee replacement). Warfarin is commonly called a "blood thinner," but the more correct term is "anticoagulant." It helps to keep blood flowing smoothly in your body by decreasing the amount of certain substances (clotting proteins) in your blood.

Which are Coumadin UNII Codes?

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

Which are Coumadin 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 Coumadin?

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.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[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.

[10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

[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".