Methylprednisolone Sodium Succinate Injection, Powder, Lyophilized, For Solution
NDC Package 82094-404-50

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

Package Information

Methylprednisolone Sodium Succinate (methylprednisolone) injection 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 injection, powder, lyophilized, for solution delivery system. Marketed by Tianjin Kingyork Pharmaceuticals Co., Ltd, this product is identified by NDC 82094-404 and is authorized under FDA application ANDA212396.

Identification & Billing

NDC Package Code
82094-404-50
Package Description
1 VIAL in 1 CARTON / 16 mL in 1 VIAL (82094-404-01)
Product Code
82094-404
11-Digit Billing Format
82094040450
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Methylprednisolone Sodium Succinate
Non-Proprietary Name
Methylprednisolone
Substance Name
Methylprednisolone Sodium Succinate
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
METHYLPREDNISOLONE SODIUM SUCCINATE 1 g/16mL
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 Kingyork Pharmaceuticals Co., Ltd
Product Type
Human Prescription Drug
FDA Application #
ANDA212396
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-20-2021
Listing Expiration
12-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 82094-404-50 identifies a specific commercial package of 1 vial in 1 carton / 16 ml in 1 vial (82094-404-01) of Methylprednisolone Sodium Succinate, a human prescription drug labeled by Tianjin Kingyork Pharmaceuticals Co., Ltd. This injection, powder, lyophilized, for solution is formulated for intramuscular; intravenous use and contains methylprednisolone sodium succinate 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 Kingyork Pharmaceuticals Co., Ltd on April 20, 2021. The current certification is valid through December 31, 2026.

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 Kingyork Pharmaceuticals Co., Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82094040450. 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)
82094-404-50
11-Digit CMS (5-4-2)
82094-0404-50

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