Methylprednisolone Acetate
NDC 63187-474
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
Methylprednisolone Acetate is a ANDA-approved product labeled by Proficient Rx Lp. Methylprednisolone is used to treat pain and swelling that occurs with arthritis and other joint disorders. It is supplied as a product. This product entry covers the primary NDC 63187-474 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
63187-474
Proprietary Name:
Methylprednisolone Acetate
Product Type: [3]
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
63187
FDA Application Number: [6]
ANDA040557
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
03-08-2005
End Marketing Date: [10]
11-30-2022
Listing Expiration Date: [11]
11-30-2022
Exclude Flag: [12]
D
Code Structure Chart
Patient Education
Methylprednisolone Injection
Methylprednisolone injection is used to treat severe allergic reactions. Methylprednisolone injection is used in the management of multiple sclerosis (a disease in which the nerves do not function properly), lupus (a disease in which the body attacks many of its own organs), gastrointestinal disease, and certain types of arthritis. Methylprednisolone injection is also used to treat certain conditions that affect the blood, skin, eyes, nervous system, thyroid, kidneys, and lungs. It is sometimes used in combination with other medications to treat symptoms of low corticosteroid levels (lack of certain substances that are usually produced by the body and are needed for normal body functioning). Methylprednisolone injection is in a class of medications called corticosteroids. It works to treat people with low levels of corticosteroids by replacing steroids that are normally produced naturally by the body. It also works to treat other conditions by reducing swelling and redness and by changing the way the immune system works.
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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 full disclaimer at the bottom of this page.
Product & Regulatory Definitions
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 End Marketing Date? This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
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".
