1. Home
  2. Labeler Index
  3. Mallinckrodt Ard Llc
  4. NDC Product Code: 63004-8711 Acthar

NDC 63004-8711 Acthar

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

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 63004-8711?
  4. Acthar Uses
  5. Active Ingredients
  6. NDC to RxNorm Crosswalk
  7. Pharmacologic Classes
  8. Patient Education

Product Information

Get all the details for National Drug Code (NDC) 63004-8711 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

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
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 Name: [5]
Mallinckrodt Ard Llc
Labeler Code:
63004
Product Label ID:
7b48ddec-e815-45f4-9ca0-5c0daaf56f30
HCPCS Code:
J0801 - Inj. acthar gel to 40 units
FDA Application Number: [6]
NDA008372
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
02-29-2024
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Code Navigator:

Code Structure Chart

Product Details

What is NDC 63004-8711?

The NDC code 63004-8711 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 subcutaneous form. The product is distributed in a single package with assigned NDC code 63004-8711-4 4 tray in 1 carton / 1 syringe in 1 tray (63004-8711-1) / 1 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 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.

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]


* 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, 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".