Esbriet Tablet, Coated
NDC Package 83107-028-27

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

Package Information

Esbriet (pirfenidone) tablets is pirfenidone is used to treat a certain lung disease called idiopathic pulmonary fibrosis (IPF). This formulation utilizes a tablet, coated delivery system. Marketed by Legacy Pharma Usa Inc., this product is identified by NDC 83107-028 and is authorized under FDA application NDA208780.

Identification & Billing

NDC Package Code
83107-028-27
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 270 TABLET, COATED in 1 BOTTLE, PLASTIC
Product Code
83107-028
11-Digit Billing Format
83107002827
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Esbriet
Non-Proprietary Name
Pirfenidone
Substance Name
Pirfenidone
Dosage Form
Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PIRFENIDONE 267 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
Legacy Pharma Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA208780
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-31-2025
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
Yes

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 83107-028-27 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 270 tablet, coated in 1 bottle, plastic of Esbriet, a human prescription drug labeled by Legacy Pharma Usa Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This tablet, 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 Legacy Pharma Usa Inc. on May 31, 2025. 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 Legacy Pharma Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83107002827. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
83107-028-27
11-Digit CMS (5-4-2)
83107-0028-27

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