Methylprednisolone Acetate Injection, Suspension
NDC 85766-195

Methylprednisolone Acetate 40 mg/mL · Injection, Suspension (intra-articular; intralesional; intramuscular; intrasynovial; soft tissue)
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 85766-195?
  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

Product Information

Methylprednisolone Acetate is a ANDA-approved product labeled by Sportpharm Llc. This medication is typically used as a corticosteroid hormone receptor agonists [moa]. It is supplied as a injection, suspension for intra-articular; intralesional; intramuscular; intrasynovial; soft tissue administration. This product entry covers the primary NDC 85766-195 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
85766-195
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]
  • Intra-articular - Administration within a joint.
  • 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]
Sportpharm Llc
Labeler Code:
85766
Product Label ID:
904b098c-9068-42ed-958f-6ab78ea42b1f
FDA Application Number: [6]
ANDA201835
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
11-15-2021
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 85766-195?

The NDC code 85766-195 is assigned by the FDA to the product Methylprednisolone Acetate. This pharmaceutical product is labeled by Sportpharm Llc and is currently categorized as listed product. The medication is a injection, suspension administered via intra-articular; 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: 85766-195-05. 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 acetate is contraindicated in patients with known hypersensitivity to the product and its constituents.Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura.Methylprednisolone acetate sterile aqueous suspension is contraindicated for intrathecal administration. Reports of severe medical events have been associated with this route of administration.Methylprednisolone acetate is contraindicated for use in premature infants because the formulation contains benzyl alcohol. (See WARNINGSand PRECAUTIONS: Pediatric Use.) Methylprednisolone acetate is contraindicated in systemic fungal infections, except when administered as an intra-articular injection for localized joint conditions (see WARNINGS: Infections, Fungal Infections).

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 40 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

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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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".