Acthar Injection
NDC 63004-8711
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Acthar (repository corticotropin) is a NDA-approved product labeled by Mallinckrodt Ard Llc. This medication is used to treat a certain type of seizure in children (infantile spasms). It is supplied as a injection for subcutaneous administration. This product entry covers the primary NDC 63004-8711 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
63004-8711
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
Code Navigator:
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]
Labeler Code:
63004
Product Label ID:
FDA Application Number: [6]
NDA008372
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
02-29-2024
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 63004-8711?
The NDC code 63004-8711 is assigned by the FDA to the product Acthar. It is commonly known by its generic name, repository corticotropin. This pharmaceutical product is labeled by Mallinckrodt Ard Llc 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 a single package configuration. The associated package NDC(s) include: 63004-8711-4. 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 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 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.
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:
- RxCUI: 1040025 - Acthar H.P. Gel 80 UNT/ML Injectable Solution
- RxCUI: 1040025 - corticotropin 80 UNT/ML Injectable Solution [Acthar]
- RxCUI: 1040025 - Acthar 80 UNT/ML Injectable Solution
- RxCUI: 1040025 - Acthar Gel 80 UNT/ML Injectable Solution
- RxCUI: 2685293 - corticotropin 80 UNT in 1 ML Prefilled Self-Controlled Injector
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
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.
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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".
