Methylprednisolone Acetate Injection, Suspension
NDC 0781-3516

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 0781-3516?
  4. Methylprednisolone Acetate Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes
  10. Patient Education

Product Information

Methylprednisolone Acetate is a ANDA-approved product labeled by Sandoz Inc.. Methylprednisolone is used to treat pain and swelling that occurs with arthritis and other joint disorders. It is supplied as a injection, suspension for intralesional; intramuscular; intrasynovial; soft tissue administration. This product entry covers the primary NDC 0781-3516 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
0781-3516
Proprietary Name:
Methylprednisolone Acetate
Non-Proprietary Name: [1]
Methylprednisolone Acetate
Substance Name: [2]
Methylprednisolone Acetate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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Clinical Specifications

Dosage Form:
Injection, Suspension - A liquid preparation, suitable for injection, which consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble. It can also consist of an oil phase dispersed throughout an aqueous phase, or vice-versa.
Administration Route(s): [4]
  • Intralesional - Administration within or introduced directly into a localized lesion.
  • Intramuscular - Administration within a muscle.
  • Intrasynovial - Administration within the synovial cavity of a joint.
  • Soft Tissue - Administration into any soft tissue.

Labeler & Regulatory Data

Labeler Name: [5]
Sandoz Inc.
Labeler Code:
0781
Product Label ID:
a363f0cd-9c8e-4622-9271-171706846b96
HCPCS Code:
J1010 - INJECTION, METHYLPREDNISOLONE ACETATE, 1 MG
FDA Application Number: [6]
ANDA214870
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
02-08-2023
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 0781-3516?

The NDC code 0781-3516 is assigned by the FDA to the product Methylprednisolone Acetate. This pharmaceutical product is labeled by Sandoz Inc. and is currently categorized as listed product. The medication is a injection, suspension administered via intralesional; intramuscular; intrasynovial; soft tissue route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 0781-3516-75. 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?

Methylprednisolone is used to treat pain and swelling that occurs with arthritis and other joint disorders. This medication may also be used to treat various conditions such as blood disorders, severe allergic reactions, certain cancers, eye conditions, skin/intestinal/kidney/lung diseases, and immune system disorders. It decreases your immune system's response to these conditions and reduces symptoms such as swelling, pain, and allergic-type reactions. Talk to your doctor about the risks and benefits of methylprednisolone, especially if it is to be injected near your spine (epidural). Rare but serious side effects may occur with epidural use. Methylprednisolone is a corticosteroid hormone. Methylprednisolone may also be used with other medications in hormone disorders.

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.
  • METHYLPREDNISOLONE ACETATE 80 mg/mL - Methylprednisolone derivative that is used as an anti-inflammatory agent for the treatment of ALLERGY and ALLERGIC RHINITIS; ASTHMA; and BURSITIS; and for the treatment of ADRENAL INSUFFICIENCY.

Which are the associated UNII Codes?

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

  • METHYLPREDNISOLONE ACETATE (UNII: 43502P7F0P)
  • METHYLPREDNISOLONE (UNII: X4W7ZR7023) (Active Moiety)

Which are the Inactive Ingredients associated 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 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: 1358610 - methylPREDNISolone acetate 40 MG/ML Injectable Suspension
  • RxCUI: 1358610 - methylprednisolone acetate 40 MG/ML Injectable Suspension
  • RxCUI: 1358617 - methylPREDNISolone acetate 80 MG/ML Injectable Suspension
  • RxCUI: 1358617 - methylprednisolone acetate 80 MG/ML Injectable Suspension

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.

* Please review the full disclaimer at the bottom of this page.

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.
[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 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".