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  4. NDC Product Code: 63275-9942 Methylprednisolone Acetate

NDC 63275-9942 Methylprednisolone Acetate

Powder - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 63275-9942?
  4. Methylprednisolone Acetate Uses
  5. Active Ingredients

Product Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.
NDC Product Code:
63275-9942
Proprietary Name:
Methylprednisolone Acetate
Non-Proprietary Name: [1]
Methylprednisolone Acetate
Substance Name: [2]
Methylprednisolone Acetate
NDC Directory Status:
Bulk Ingredient
Product Type: [3]
UNFINISHED PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Labeler Name: [5]
B&b Pharmaceuticals, Inc.
Labeler Code:
63275
Marketing Category: [8]
BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING - A category specifying that a bulk product is intended for use on humans and requires a prescription.
Start Marketing Date: [9]
01-01-2017
End Marketing Date: [10]
11-01-2025
Exclude Flag: [12]
N
Unfinished Product: [13]
Yes
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Product Details

What is NDC 63275-9942?

The NDC code 63275-9942 is assigned by the FDA to the UNFINISHED product Methylprednisolone Acetate which is a bulk ingredient product labeled by B&b Pharmaceuticals, Inc.. The generic name of Methylprednisolone Acetate is methylprednisolone acetate. The product's dosage form is powder. The product is distributed in 5 packages with assigned NDC codes 63275-9942-2 5 g in 1 bottle, plastic , 63275-9942-4 25 g in 1 bottle, plastic , 63275-9942-5 100 g in 1 bottle, plastic , 63275-9942-8 500 g in 1 bottle, plastic , 63275-9942-9 1000 g in 1 bottle, plastic . 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 Methylprednisolone Acetate?

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 Methylprednisolone Acetate 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.
  • METHYLPREDNISOLONE ACETATE 1 g/g - 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.

* 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.

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[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.

[10] 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.

[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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

[13] What is an Unfinished Product? - This field indicates if the product is an unfinished drug. An unfinished drug is an active pharmaceutical ingredient either alone or with other ingredients that is not a finished drug product. Unfinished drugs are used to process other drugs or for drug compounding.