Prolia Injection
NDC 55513-710

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 55513-710?
  4. Prolia Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes
  10. Patient Education

Product Information

Prolia (denosumab) is a BLA-approved product labeled by Amgen, Inc. Denosumab is used to treat bone loss (osteoporosis) in people who have a high risk of getting fractures. It is supplied as a injection for subcutaneous administration. This product entry covers the primary NDC 55513-710 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
55513-710
Proprietary Name:
Prolia
Non-Proprietary Name: [1]
Denosumab
Substance Name: [2]
Denosumab
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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Clinical Specifications

Dosage Form:
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s): [4]
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.

Labeler & Regulatory Data

Labeler Name: [5]
Amgen, Inc
Labeler Code:
55513
Product Label ID:
49e5afe9-a0c7-40c4-af9f-f287a80c5c88
HCPCS Code:
J0897 - INJECTION, DENOSUMAB, 1 MG
FDA Application Number: [6]
BLA125320
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.

Marketing Timeline

Start Marketing Date: [9]
06-05-2010
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 55513-710?

The NDC code 55513-710 is assigned by the FDA to the product Prolia. It is commonly known by its generic name, denosumab. This pharmaceutical product is labeled by Amgen, Inc and is currently categorized as listed product. The medication is a injection administered via subcutaneous route. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 55513-710-01, 55513-710-21. 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?

Denosumab is used to treat bone loss (osteoporosis) in people who have a high risk of getting fractures. Osteoporosis causes bones to become thinner and break more easily. Your chance of developing osteoporosis increases after menopause (in women), as you age, if someone in your family has osteoporosis, or if you take certain medications (such as prednisone) for long periods. This medication works by slowing bone loss to help maintain strong bones and reduce the risk of broken bones (fractures). Denosumab belongs to a class of drugs called monoclonal antibodies. It prevents certain cells in the body (osteoclasts) from breaking down bone.

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.
  • DENOSUMAB 60 mg/mL - A humanized monoclonal antibody and an inhibitor of the RANK LIGAND, which regulates OSTEOCLAST differentiation and bone remodeling. It is used as a BONE DENSITY CONSERVATION AGENT in the treatment of OSTEOPOROSIS.

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

Denosumab Injection


Denosumab injection (Prolia) is used to treat osteoporosis (a condition in which the bones become thin and weak and break easily) in women who have undergone menopause (''change of life;'' end of menstrual periods) who have an increased risk for fractures (broken bones) or who cannot take or did not respond to other medication treatments for osteoporosis. to treat men who have an increased risk for fractures (broken bones) or who cannot take or did not respond to other medication treatments for osteoporosis. treat osteoporosis that is caused by corticosteroid medications in men and women who will be taking corticosteroid medications for at least 6 months and have an increased risk for fractures or who cannot take or did not respond to other medication treatments for osteoporosis. to treat bone loss in men who are being treated for prostate cancer with certain medications that cause bone loss, to treat bone loss in women with breast cancer who are receiving certain medications that increase their risk for fractures. Denosumab injection (Xgeva) is used to reduce the risk of fractures in people who have multiple myeloma (cancer that begins in the plasma cells and causes bone damage), and in people who have certain types of cancer that began in another part of the body but has spread to the bones. in adults and some adolescents to treat giant cell tumor of bone (GCTB; a type of bone tumor) that cannot be treated with surgery. to treat high calcium levels that are caused by cancer in people who did not respond to other medications.Denosumab injection is in a class of medications called RANK ligand inhibitors. It works to prevent bone loss by blocking a certain receptor in the body to decrease bone breakdown. It works to treat GCTB by blocking a certain receptor in the tumor cells which slows the tumor growth. It works to treat high calcium levels by decreasing bone breakdown as the breakdown of bones releases calcium.
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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".