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NDC 55150-437 Dexrazoxane

Kit - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 55150-437?
  4. Dexrazoxane Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk
  8. Patient Education

Product Information

NDC Product Code:
55150-437
Proprietary Name:
Dexrazoxane
Non-Proprietary Name: [1]
Dexrazoxane
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Labeler Name: [5]
Eugia Us Llc
Labeler Code:
55150
Product Label ID:
be9ac1e9-21a9-439a-9029-9f03513220ea
FDA Application Number: [6]
ANDA200752
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
05-12-2016
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Code Structure:
Code Navigator:

Product Packages

NDC Code 55150-437-01

Package Description: 1 KIT in 1 PACKAGE * 50 mL in 1 VIAL, SINGLE-DOSE (55150-435-01) * 50 mL in 1 VIAL (55150-436-01)

Product Details

What is NDC 55150-437?

The NDC code 55150-437 is assigned by the FDA to the product Dexrazoxane which is a human prescription drug product labeled by Eugia Us Llc. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 55150-437-01 1 kit in 1 package * 50 ml in 1 vial, single-dose (55150-435-01) * 50 ml in 1 vial (55150-436-01). 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 Dexrazoxane?

Dexrazoxane is used to reduce the risk and severity of heart damage caused by doxorubicin treatment and similar cancer chemotherapy medications. Heart damage limits the length of time you can be treated with doxorubicin. Dexrazoxane allows you to continue doxorubicin treatment for longer. When used for this purpose, dexrazoxane treatment is usually started after you have received several doses of doxorubicin. It is usually not given with the first doses of doxorubicin since doing so may reduce the effectiveness of doxorubicin.

Which are Dexrazoxane UNII Codes?

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

Which are Dexrazoxane 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 Dexrazoxane?

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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Patient Education

Dexrazoxane Injection


Dexrazoxane injection (Totect, Zinecard) is used to prevent or decrease thickening of the heart muscles caused by doxorubicin in women who are taking the medication to treat breast cancer that has spread to other parts of the body. Dexrazoxane injection (Totect, Zinecard) is only given to women who have already received a certain amount of doxorubicin and who will need continued doxorubicin treatment, it is not used to prevent heart damage in women who are starting treatment with doxorubicin. Dexrazoxane injection (Totect) is used to decrease damage to the skin and tissues that may be caused when an anthracycline chemotherapy medication such as daunorubicin (Cerubidine), doxorubicin (Adriamycin, Doxil), epirubicin (Ellence) or idarubicin (Idamycin) leaks out of a vein as it is being injected. Dexrazoxane injection is in classes of medications called cardioprotectants and chemoprotectants. It works by stopping the chemotherapy medications from damaging the heart and the tissues.
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Product Footnotes

[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

[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.

[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".