Eltrombopag Tablet, Film Coated
NDC 72205-159

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 72205-159?
  5. Eltrombopag Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

Eltrombopag (eltrombopag olamine) is a ANDA-approved product labeled by Novadoz Pharmaceuticals Llc. This medication is used to treat low platelet levels in people who have a certain blood disorder called chronic immune (idiopathic) thrombocytopenia purpura (ITP) or who have chronic hepatitis C. It is supplied as a white tablet, film coated for oral administration. This product entry covers the primary NDC 72205-159 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
72205-159
Proprietary Name:
Eltrombopag
Non-Proprietary Name: [1]
Eltrombopag Olamine
Substance Name: [2]
Eltrombopag Olamine
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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Clinical Specifications

Dosage Form:
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Novadoz Pharmaceuticals Llc
Labeler Code:
72205
Product Label ID:
5a9ec8c8-3c0b-4f11-848c-c04ccee0d44f
FDA Application Number: [6]
ANDA220250
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
01-14-2026
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Product Characteristics

Color(s):
WHITE (C48325)
ORANGE (C48331)
BLUE (C48333)
BROWN (C48332)
Shape:
ROUND (C48348)
Size(s):
6 MM
7 MM
9 MM
10 MM
Imprint(s):
ME;12
ME;13
ME;14
ME;15
Score:
1

Code Structure Chart

Product Details

What is NDC 72205-159?

The NDC code 72205-159 is assigned by the FDA to the product Eltrombopag. It is commonly known by its generic name, eltrombopag olamine. This pharmaceutical product is labeled by Novadoz Pharmaceuticals Llc and is currently categorized as listed product. The medication is a tablet, film coated administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 72205-159-30. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

This medication is used to treat low platelet levels in people who have a certain blood disorder called chronic immune (idiopathic) thrombocytopenia purpura (ITP) or who have chronic hepatitis C. It may also be used to treat people with a certain blood disorder (aplastic anemia). Platelets are a type of blood cell needed to form blood clots and prevent bleeding. Eltrombopag decreases your risk of bleeding by increasing the number of platelets. Eltrombopag acts like a certain natural substance (thrombopoietin) that causes the body to produce platelets.

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Which are the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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 this product?

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:

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Patient Education

Eltrombopag


Eltrombopag is used to increase the number of platelets (cells that help the blood clot) to decrease the risk of bleeding in adults and children 1 year of age and older who have chronic immune thrombocytopenia (ITP; an ongoing condition that may cause unusual bruising or bleeding due to an abnormally low number of platelets in the blood) and who have not been helped or cannot be treated with other treatments, including medications or surgery to remove the spleen. Eltrombopag is also used to increase the number of platelets in people who have hepatitis C (a viral infection that may damage the liver) so that they can begin and continue treatment with interferon (Peginterferon, Pegintron, others) and ribavirin (Rebetol). Eltrombopag is also used in combination with other medications to treat aplastic anemia (condition in which the body does not make enough new blood cells) in adults and children 2 years of age and older. It is also used to treat aplastic anemia in adults who have not been helped with other medications. Eltrombopag is used to increase the number of platelets enough to decrease the risk of bleeding in people with ITP or aplastic anemia, or to allow treatment with interferon and ribavirin in people with hepatitis C. However it is not used to increase the number of platelets to a normal level. Eltrombopag should not be used to treat people who have low numbers of platelets due to conditions other than ITP, hepatitis C, or aplastic anemia. Eltrombopag is in a class of medications called thrombopoietin receptor agonists. It works by causing the cells in the bone marrow to produce more platelets.
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* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
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.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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".