NDC 55513-025 Aranesp

Darbepoetin Alfa Injection, Solution Intravenous; Subcutaneous - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
55513-025
Proprietary Name:
Aranesp
Non-Proprietary Name: [1]
Darbepoetin Alfa
Substance Name: [2]
Darbepoetin Alfa
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route(s): [4]
  • Intravenous - Administration within or into a vein or veins.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
  • Labeler Name: [5]
    Labeler Code:
    55513
    FDA Application Number: [6]
    BLA103951
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    08-14-2006
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
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    Product Details

    What is NDC 55513-025?

    The NDC code 55513-025 is assigned by the FDA to the product Aranesp which is a human prescription drug product labeled by Amgen Inc. The generic name of Aranesp is darbepoetin alfa. The product's dosage form is injection, solution and is administered via intravenous; subcutaneous form. The product is distributed in a single package with assigned NDC code 55513-025-04 1 blister pack in 1 package / 4 syringe in 1 blister pack / .5 ml in 1 syringe (55513-025-01). 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 Aranesp?

    This medication is used to treat anemia (low red blood cell count) in people with long-term serious kidney disease (chronic kidney failure) and people receiving chemotherapy for some types of cancer (cancer that does not involve the bone marrow or blood cells). Darbepoetin alfa also helps to reduce the need for blood transfusions. It works by signaling the bone marrow to make more red blood cells. This medication is very similar to the natural substance in your body (erythropoietin) that prevents anemia.

    What are Aranesp Active Ingredients?

    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 Aranesp UNII Codes?

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

    Which are Aranesp 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 Aranesp?

    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:
    • RxCUI: 1605171 - darbepoetin alfa 10 MCG in 0.4 ML Prefilled Syringe
    • RxCUI: 1605171 - 0.4 ML darbepoetin alfa 0.025 MG/ML Prefilled Syringe
    • RxCUI: 1605171 - darbepoetin alfa 10 MCG per 0.4 ML Prefilled Syringe
    • RxCUI: 1605172 - Aranesp 10 MCG in 0.4 ML Prefilled Syringe
    • RxCUI: 1605172 - 0.4 ML darbepoetin alfa 0.025 MG/ML Prefilled Syringe [Aranesp]

    Which are the Pharmacologic Classes for Aranesp?

    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

    Darbepoetin Alfa Injection


    Darbepoetin alfa injection is used to treat anemia (a lower than normal number of red blood cells) in people with chronic kidney failure (condition in which the kidneys slowly and permanently stop working over a period of time). Darbepoetin alfa injection is also used to treat anemia caused by chemotherapy in people with certain types of cancer. Darbepoetin alfa cannot be used in place of a red blood cell transfusion to treat severe anemia and has not been shown to improve tiredness or poor well-being that may be caused by anemia. Darbepoetin alfa is in a class of medications called erythropoiesis-stimulating agents (ESAs). It works by causing the bone marrow (soft tissue inside the bones where blood is made) to make more red blood cells.
    [Learn More]


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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.

    [2] 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.

    [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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [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".