Prednisone Powder
NDC Package 57582-003-04

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

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.

Prednisone powders is prednisone is used to treat conditions such as arthritis, blood disorders, breathing problems, severe allergies, skin diseases, cancer, eye problems, and immune system disorders. This formulation utilizes a powder delivery system. Marketed by Tianjin Tianyao Pharmaceuticals Co., Ltd., this product is identified by NDC 57582-003.

Identification & Billing

NDC Package Code
57582-003-04
Package Description
1 BAG in 1 DRUM / 25 kg in 1 BAG
Product Code
57582-003
11-Digit Billing Format
57582000304

Clinical Specifications

Proprietary Name
Prednisone
Non-Proprietary Name
Prednisone
Substance Name
Prednisone
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
PREDNISONE 1 kg/kg
Usage Information
Prednisone is used to treat conditions such as arthritis, blood disorders, breathing problems, severe allergies, skin diseases, cancer, eye problems, and immune system disorders. Prednisone belongs to a class of drugs known as corticosteroids. It decreases your immune system's response to various diseases to reduce symptoms such as swelling and allergic-type reactions.

Regulatory & Marketing

Labeler Name
Tianjin Tianyao Pharmaceuticals Co., Ltd.
Product Type
Bulk Ingredient
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
02-01-2012
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 (57582-003). Click a package code to view its specific billing and regulatory data.

57582-003-03
5 kg in 1 BAG

* 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 57582-003-04 identifies a specific commercial package of 1 bag in 1 drum / 25 kg in 1 bag of Prednisone (UNFINISHED drug), a bulk ingredient labeled by Tianjin Tianyao Pharmaceuticals Co., Ltd.. This powder is formulated for use and contains prednisone 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 February 01, 2012. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Prednisone is used to treat conditions such as arthritis, blood disorders, breathing problems, severe allergies, skin diseases, cancer, eye problems, and immune system disorders. Prednisone belongs to a class of drugs known as corticosteroids. It decreases your immune system's response to various diseases to reduce symptoms such as swelling and allergic-type reactions.

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: 57582000304. 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)
57582-003-04
11-Digit CMS (5-4-2)
57582-0003-04

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