Pirfenidone Tablet, Film Coated
NDC Package 42385-925-90

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

Package Information

Pirfenidone tablets is pirfenidone is used to treat a certain lung disease called idiopathic pulmonary fibrosis (IPF). This formulation utilizes a tablet, film coated delivery system. Marketed by Laurus Labs Limited, this product is identified by NDC 42385-925 and is authorized under FDA application ANDA212722.

Identification & Billing

NDC Package Code
42385-925-90
Package Description
90 TABLET, FILM COATED in 1 BOTTLE
Product Code
42385-925
11-Digit Billing Format
42385092590
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
90 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Pirfenidone
Non-Proprietary Name
Pirfenidone
Substance Name
Pirfenidone
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PIRFENIDONE 534 mg/1
Pharmacologic Class
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
Laurus Labs Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA212722
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-19-2022
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 42385-925-90 identifies a specific commercial package of 90 tablet, film coated in 1 bottle of Pirfenidone, a human prescription drug labeled by Laurus Labs Limited. This product is billed for "EA" each discreet unit and contains an estimated amount of 90 billable units per package. This tablet, film coated is formulated for oral 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 Laurus Labs Limited on July 19, 2022. 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 Laurus Labs Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42385092590. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 90 total billable units per package. 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)
42385-925-90
11-Digit CMS (5-4-2)
42385-0925-90

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