Pirfenidone Powder
NDC Package 60862-005-04

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.

Pirfenidone powders is pirfenidone is used to treat a certain lung disease called idiopathic pulmonary fibrosis (IPF). This formulation utilizes a powder delivery system. Marketed by Tyche Industries Limited, this product is identified by NDC 60862-005.

Identification & Billing

NDC Package Code
60862-005-04
Package Description
1 BAG in 1 DRUM / 20 kg in 1 BAG
Product Code
60862-005
11-Digit Billing Format
60862000504

Clinical Specifications

Proprietary Name
Pirfenidone
Non-Proprietary Name
Pirfenidone
Substance Name
Pirfenidone
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)
PIRFENIDONE 25 kg/25kg
Usage Information
Pirfenidone is used to treat a certain lung disease called idiopathic pulmonary fibrosis (IPF). This disease causes the lungs to get scarred and become stiff, making it hard to breathe. Pirfenidone may help slow down the worsening of your IPF.

Regulatory & Marketing

Labeler Name
Tyche Industries Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
10-15-2014
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 (60862-005). Click a package code to view its specific billing and regulatory data.

60862-005-01
1 BAG in 1 DRUM / 1 kg in 1 BAG
60862-005-02
1 BAG in 1 DRUM / 5 kg in 1 BAG
60862-005-03
1 BAG in 1 DRUM / 10 kg in 1 BAG
60862-005-05
1 BAG in 1 DRUM / 25 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 60862-005-04 identifies a specific commercial package of 1 bag in 1 drum / 20 kg in 1 bag of Pirfenidone (UNFINISHED drug), a bulk ingredient labeled by Tyche Industries Limited. This powder is formulated for use and contains pirfenidone 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 Tyche Industries Limited on October 15, 2014. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Pirfenidone is used to treat a certain lung disease called idiopathic pulmonary fibrosis (IPF). This disease causes the lungs to get scarred and become stiff, making it hard to breathe. Pirfenidone may help slow down the worsening of your IPF.

How is this Tyche Industries Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60862000504. 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)
60862-005-04
11-Digit CMS (5-4-2)
60862-0005-04

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