NDC 57894-060 Stelara

Ustekinumab Injection, Solution Subcutaneous - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
57894-060
Proprietary Name:
Stelara
Non-Proprietary Name: [1]
Ustekinumab
Substance Name: [2]
Ustekinumab
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]
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
  • Labeler Code:
    57894
    FDA Application Number: [6]
    BLA125261
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    09-25-2009
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
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    Product Details

    What is NDC 57894-060?

    The NDC code 57894-060 is assigned by the FDA to the product Stelara which is a human prescription drug product labeled by Janssen Biotech, Inc.. The generic name of Stelara is ustekinumab. The product's dosage form is injection, solution and is administered via subcutaneous form. The product is distributed in 3 packages with assigned NDC codes 57894-060-02 1 vial, single-use in 1 carton / .5 ml in 1 vial, single-use, 57894-060-03 1 syringe in 1 carton / .5 ml in 1 syringe, 57894-060-04 1 syringe in 1 carton / .5 ml in 1 syringe. 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 Stelara?

    Ustekinumab is used to treat plaque psoriasis, a certain type of arthritis (psoriatic arthritis), or certain bowel conditions (Crohn's disease, ulcerative colitis). It works by blocking certain natural proteins in your body (interleukin-12 and interleukin-23) that cause inflammation (swelling) in these conditions. Ustekinumab does not cure these diseases, but helps to lessen symptoms of the disease. It can help to decrease the amount of plaques in plaque psoriasis, decrease the number of swollen/painful joints in psoriatic arthritis, and decrease symptoms such as abdominal pain/cramping and diarrhea in Crohn's disease and ulcerative colitis.

    What are Stelara 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.
    • USTEKINUMAB 45 mg/.5mL - A humanized monoclonal antibody that binds to IL-12 and IL-23 and is used as a DERMATOLOGIC AGENT in the treatment of patients with plaque PSORIASIS who have not responded to other therapies.

    Which are Stelara UNII Codes?

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

    Which are Stelara 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 Stelara?

    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 for Stelara?

    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

    Ustekinumab Injection


    Ustekinumab injection is used to treat moderate to severe plaque psoriasis (skin disease in which red, scaly patches form on some areas of the body) in adults and children 6 years or older who may benefit from medications or phototherapy (a treatment that involves exposing the skin to ultraviolet light). It is also used alone or in combination with methotrexate (Otrexup, Rasuvo, Trexall) to treat psoriatic arthritis (a condition that causes joint pain and swelling and scales on the skin) in adults. Ustekinumab injection is also used to treat Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) in adults. Ustekinumab injection is also used to treat ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum) in adults. Ustekinumab injection is in a class of medications called monoclonal antibodies. It works by stopping the action of certain cells in the body that cause the symptoms of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.
    [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".