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  4. NDC Product Code: 70710-1013 Deferasirox

NDC 70710-1013 Deferasirox

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 70710-1013?
  5. Deferasirox Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Get all the details for National Drug Code (NDC) 70710-1013 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
70710-1013
Proprietary Name:
Deferasirox
Product Type: [3]
Labeler Name: [5]
Zydus Pharmaceuticals Usa Inc.
Labeler Code:
70710
Product Label ID:
bfb4db4a-88e6-4c36-afeb-cb0ea00ae2ac
FDA Application Number: [6]
ANDA208882
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
05-06-2021
End Marketing Date: [10]
04-07-2025
Listing Expiration Date: [11]
04-07-2025
Exclude Flag: [12]
D
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - WHITE TO OFF WHITE)
Shape:
ROUND (C48348)
Size(s):
18 MM
Imprint(s):
1013
Score:
1

Code Structure Chart

Product Details

What is NDC 70710-1013?

The NDC code 70710-1013 is assigned by the FDA to the product Deferasirox which is product labeled by Zydus Pharmaceuticals Usa Inc.. The product's dosage form is . The product is distributed in 3 packages with assigned NDC codes 70710-1013-1 100 tablet, for suspension in 1 bottle , 70710-1013-3 30 tablet, for suspension in 1 bottle , 70710-1013-9 90 tablet, for suspension 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 Deferasirox?

This medication is used to treat ongoing high levels of iron in the body caused by multiple blood transfusions. It is also used to treat high levels of iron in people with a certain blood disorder who do not require blood transfusions (non-transfusion-dependent thalassemia). It works by binding to iron, allowing the body to pass extra iron out in the stool. Deferasirox belongs to a class of drugs known as iron-chelating agents. Frequent blood transfusions are often needed in certain types of blood diseases (such as sickle cell disease, anemia). Blood transfusions have very helpful benefits, but they can cause the body to hold on to too much iron. The extra iron can build up in the body and cause problems such as heart failure, liver disease, and diabetes. Getting rid of extra iron can decrease the risk of these diseases.

Which are Deferasirox UNII Codes?

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

Which are Deferasirox 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:

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Patient Education

Deferasirox


Deferasirox is used to treat adults and children 2 years of age and older who have too much iron in their body because they received many blood transfusions. It is also used to treat adults and children 10 years of age and older who have too much iron in their body because of a genetic blood disorder called non–transfusion-dependent thalassemia (NTDT). Deferasirox is in a class of medications called iron chelators. It works by attaching to iron in the body so that it can be excreted (removed from the body) in feces.
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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.

[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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".