NDC 63004-8710 Acthar

Repository Corticotropin Injection Intramuscular; Subcutaneous - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
63004-8710
Proprietary Name:
Acthar
Non-Proprietary Name: [1]
Repository Corticotropin
Substance Name: [2]
Corticotropin
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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]
  • Intramuscular - Administration within a muscle.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
  • Labeler Name: [5]
    Mallinckrodt Ard Llc
    Labeler Code:
    63004
    FDA Application Number: [6]
    NDA008372
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    01-07-2013
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 63004-8710-1

    Package Description: 1 VIAL, MULTI-DOSE in 1 CARTON / 5 mL in 1 VIAL, MULTI-DOSE

    NDC Code 63004-8710-2

    Package Description: 1 VIAL, MULTI-DOSE in 1 CARTON / 5 mL in 1 VIAL, MULTI-DOSE

    Product Details

    What is NDC 63004-8710?

    The NDC code 63004-8710 is assigned by the FDA to the product Acthar which is a human prescription drug product labeled by Mallinckrodt Ard Llc. The generic name of Acthar is repository corticotropin. The product's dosage form is injection and is administered via intramuscular; subcutaneous form. The product is distributed in 2 packages with assigned NDC codes 63004-8710-1 1 vial, multi-dose in 1 carton / 5 ml in 1 vial, multi-dose, 63004-8710-2 1 vial, multi-dose in 1 carton / 5 ml in 1 vial, multi-dose. 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 Acthar?

    This medication is used to treat a certain type of seizure in children (infantile spasms). This medication is also used to treat conditions such as multiple sclerosis, arthritis, lupus, eye conditions, skin/kidney/lung diseases, and immune system disorders. It decreases your immune system's response to various diseases to reduce symptoms such as swelling, pain, and allergic-type reactions. Corticotropin is a hormone.

    What are Acthar 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 Acthar UNII Codes?

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

    Which are Acthar 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 Acthar?

    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 Acthar?

    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.

    * Please review the disclaimer below.

    Patient Education

    Corticotropin, Repository Injection


    Corticotropin repository injection is used to treat the following conditions: infantile spasms (seizures that usually begin during the first year of life and may be followed by developmental delays) in infants and children younger than 2 years of age; episodes of symptoms in people who have multiple sclerosis (MS; a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control); episodes of symptoms in people who have rheumatoid arthritis (a condition in which the body attacks its own joints, causing pain, swelling, and loss of function); episodes of symptoms in people who have psoriatic arthritis (a condition that causes joint pain and swelling and scales on the skin); episodes of symptoms in people who have ankylosing spondylitis (a condition in which the body attacks the joints of the spine and other areas, causing pain and joint damage); lupus (a condition in which the body attacks many of its own organs); systemic dermatomyositis (condition that causes muscle weakness and skin rash) or polymyositis (condition that causes muscle weakness but not skin rash); serious allergic reactions that affect the skin including Stevens-Johnson syndrome (a severe allergic reaction that may cause the top layer of skin to blister and shed); serum sickness (a serious allergic reaction that occurs several days after taking certain medications and causes skin rash, fever, joint pain, and other symptoms); allergic reactions or other conditions that cause swelling of the eyes and the area around them; sarcoidosis (condition in which small clumps of immune cells form in various organs such as the lungs, eyes, skin, and heart and interfere with the function of these organs); nephrotic syndrome (a group of symptoms including protein in the urine; low levels of protein in the blood; high levels of certain fats in the blood; and swelling of the arms, hands, feet, and legs). Corticotropin repository injection is in a class of medications called hormones. It treats many conditions by decreasing the activity of the immune system so that it will not cause damage to the organs. There is not enough information to tell how corticotropin repository injection works to treat infantile spasms.
    [Learn More]


    Steroids


    You may have heard of anabolic steroids, which can have harmful effects. But there's another type of steroid - sometimes called a corticosteroid - that treats a variety of problems. These steroids are similar to hormones that your adrenal glands make to fight stress associated with illnesses and injuries. They reduce inflammation and affect the immune system.

    You may need to take corticosteroids to treat:

    • Arthritis
    • Asthma
    • Autoimmune diseases such as lupus and multiple sclerosis
    • Skin conditions such as eczema and rashes
    • Some kinds of cancer

    Steroids are strong medicines, and they can have side effects, including weakened bones and cataracts. Because of this, you usually take them for as short a time as possible.


    [Learn More]


    * Please review the disclaimer below.

    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".