Esbriet
NDC Package 50242-121-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Esbriet is pirfenidone is used to treat a certain lung disease called idiopathic pulmonary fibrosis (IPF). Marketed by Genentech, Inc., this product is identified by NDC 50242-121 and is authorized under FDA application NDA022535.

Identification & Billing

NDC Package Code
50242-121-01
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 270 CAPSULE in 1 BOTTLE, PLASTIC
Product Code
50242-121
11-Digit Billing Format
50242012101
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
Dosage Form
-
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
Genentech, Inc.
FDA Application #
NDA022535
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-15-2014
End Marketing Date
09-30-2025
Listing Expiration
09-30-2025
Exclude Flag
D
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 50242-121-01 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 270 capsule in 1 bottle, plastic of Esbriet, labeled by Genentech, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Genentech, Inc. on October 15, 2014. The current certification is valid through September 30, 2025.

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 Genentech, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50242012101. 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)
50242-121-01
11-Digit CMS (5-4-2)
50242-0121-01

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