NDC Compounded Drug 69852-916-10 Methylprednisolone Acetate

Injection, Suspension Intramuscular

Table of Contents

    1. Compounded Product Information
    2. NDC Crossover Products Matching Methylprednisolone Acetate 80 Mg/ml
    3. Frequently Asked Questions

Compounded Drug Product Information

NDC Product Code 69852-916
NDC Package Code 69852-916-10
11-Digit NDC Billing Format NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.		 69852091610
Package Description 800 mg in 1 VIAL, MULTI-DOSE
Product Type 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.		 Human Compounded Drug
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		 Methylprednisolone Acetate 80 Mg/ml
Non-Proprietary Name 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.		 Methylprednisolone Acetate 80 Mg/ml
Substance Name 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.		 Methylprednisolone Acetate
Usage Information Product Usage Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.		 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.
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.
Route Name Intramuscular - Administration within a muscle.
Marketing Category OUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS)
Labeler Code 69852
Labeler Name What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		 Eagle Pharmacy, Inc.
Substance Name Methylprednisolone Acetate
Active Ingredients Information 80 mg/80 mg
Reporting Period 2021-2

NDC Crossover Products Matching Methylprednisolone Acetate

NDC crossover of Methylprednisolone Acetate 80 Mg/ml with NDC 69852-916 a human compounded drug with other similar products matching the same substance name (Methylprednisolone Acetate) and the same administration route (intramuscular) or dosage form (injection, suspension).

Frequently Asked Questions

What is the NDC number assigned to Methylprednisolone Acetate?

Methylprednisolone Acetate was assigned by its manufacturer with NDC product code 69852-916. This product is a drug classified as a human compounded drug. Compounded drugs are medications created by combining or altering existing drugs to meet the specific needs of certain patients. The NDC directory only includes information about compounded drugs from facilities that choose to assign NDC numbers to their products.

Which are the NDC package codes for Methylprednisolone Acetate?

The NDC package code 69852-916-10 was assigned to a 800 mg in 1 VIAL, MULTI-DOSE of methylprednisolone acetate administered intramuscular via injection, suspension.

Who manufactures this product?

Methylprednisolone Acetate is manufactured by an outsourced facility and labeled by Eagle Pharmacy, Inc.. All compounded drugs included in the NDC directory are classified as "Outsourcing Facility Compounded Human Drug Product (Exempt from Approval Requirements)". Outsourcing facilities are a type of drug compounding facility regulated under Section 503B of the FD&C Act could be eligible for exemptions from drug registration if they meet all the conditions specified under Section 503B.

Which are the NDC crossover matchings for this product?

We found 3 matching products that have the same substance, dosage form and administration route. The matching products are manufactured by Eagle Pharmacy, Inc. and Brookfield Medical Surgical Supply with NDC product codes 69852-115-10, 72907-2115-3 and 72907-2115-5.