NDC 69097-391 Deferasirox

Deferasirox

NDC Product Code 69097-391

NDC CODE: 69097-391

Proprietary Name: Deferasirox What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Deferasirox 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • 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.

NDC Code Structure

NDC 69097-391-02

Package Description: 30 TABLET, COATED in 1 BOTTLE

NDC 69097-391-20

Package Description: 5 BLISTER PACK in 1 CARTON > 10 TABLET, COATED in 1 BLISTER PACK (69097-391-19)

NDC Product Information

Deferasirox with NDC 69097-391 is a a human prescription drug product labeled by Cipla Usa Inc.. The generic name of Deferasirox is deferasirox. The product's dosage form is tablet, coated and is administered via oral form.

Labeler Name: Cipla Usa Inc.

Dosage Form: Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.

Product Type: Human Prescription Drug 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.

Deferasirox Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • DEFERASIROX 90 mg/1

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Iron Chelating Activity - [MoA] (Mechanism of Action)
  • Iron Chelator - [EPC] (Established Pharmacologic Class)
  • Cytochrome P450 3A4 Inducers - [MoA] (Mechanism of Action)
  • Cytochrome P450 2C8 Inhibitors - [MoA] (Mechanism of Action)
  • Cytochrome P450 1A2 Inhibitors - [MoA] (Mechanism of Action)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Cipla Usa Inc.
Labeler Code: 69097
FDA Application Number: ANDA211852 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.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. 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.

Start Marketing Date: 02-13-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

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