Methylprednisolone Tablet
NDC Package 57582-101-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Methylprednisolone tablets is methylprednisolone is used to treat conditions such as arthritis, blood disorders, severe allergic reactions, certain cancers, eye conditions, skin/kidney/intestinal/lung diseases, and immune system disorders. This formulation utilizes a tablet delivery system. Marketed by Tianjin Tianyao Pharmaceuticals Co., Ltd., this product is identified by NDC 57582-101 and is authorized under FDA application ANDA204072.

Identification & Billing

NDC Package Code
57582-101-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
57582-101
11-Digit Billing Format
57582010101
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Methylprednisolone
Non-Proprietary Name
Methylprednisolone
Substance Name
Methylprednisolone
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
METHYLPREDNISOLONE 4 mg/1
Pharmacologic Class
Usage Information
Methylprednisolone is used to treat conditions such as arthritis, blood disorders, severe allergic reactions, certain cancers, eye conditions, skin/kidney/intestinal/lung diseases, and immune system disorders. It decreases your immune system's response to various diseases to reduce symptoms such as swelling, pain, and allergic-type reactions. This medication is a corticosteroid hormone. Methylprednisolone may also be used with other medications in hormone disorders.

Regulatory & Marketing

Labeler Name
Tianjin Tianyao Pharmaceuticals Co., Ltd.
Product Type
Human Prescription Drug
FDA Application #
ANDA204072
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-14-2018
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

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

Other Available Packages

The following commercial packages are registered under the same Product NDC (57582-101). Click a package code to view its specific billing and regulatory data.

57582-101-02
1 BLISTER PACK in 1 CARTON / 21 TABLET in 1 BLISTER PACK

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

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 57582-101-01 identifies a specific commercial package of 100 tablet in 1 bottle of Methylprednisolone, a human prescription drug labeled by Tianjin Tianyao Pharmaceuticals Co., Ltd.. This tablet is formulated for oral use and contains methylprednisolone as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Tianjin Tianyao Pharmaceuticals Co., Ltd. on May 14, 2018. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Methylprednisolone is used to treat conditions such as arthritis, blood disorders, severe allergic reactions, certain cancers, eye conditions, skin/kidney/intestinal/lung diseases, and immune system disorders. It decreases your immune system's response to various diseases to reduce symptoms such as swelling, pain, and allergic-type reactions. This medication is a corticosteroid hormone. Methylprednisolone may also be used with other medications in hormone disorders.

How is this Tianjin Tianyao Pharmaceuticals Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57582010101. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
57582-101-01
11-Digit CMS (5-4-2)
57582-0101-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.