NDC Package 33342-461-58 Pirfenidone Capsule, 267 Mg

Capsule Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information
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Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

33342-461-58

Package Description:

270 CAPSULE in 1 BOTTLE

Product Code:

33342-461

Proprietary Name:

Pirfenidone Capsule, 267 Mg

Non-Proprietary Name:

Pirfenidone Capsule, 267 Mg

Substance Name:

Pirfenidone

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.

11-Digit NDC Billing Format:

33342046158

NDC to RxNorm Crosswalk:

RxCUI: 1592279 - pirfenidone 267 MG Oral Capsule

Product Type:

Human Prescription Drug

Labeler Name:

Macleods Pharmaceuticals Limited

Dosage Form:

Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.

Administration Route(s):

Oral - Administration to or by way of the mouth.

Active Ingredient(s):

PIRFENIDONE 267 mg/1

Pharmacologic Class(es):

Sample Package:

FDA Application Number:

ANDA212748

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

07-20-2020

Listing Expiration Date:

12-31-2026

Exclude Flag:

Code Structure:

33342 - Macleods Pharmaceuticals Limited
- 33342-461 - Pirfenidone Capsule, 267 Mg
  - 33342-461-58 - 270 CAPSULE in 1 BOTTLE

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
33342-461-38	1 BLISTER PACK in 1 CARTON / 63 CAPSULE in 1 BLISTER PACK
33342-461-82	1 BLISTER PACK in 1 CARTON / 252 CAPSULE in 1 BLISTER PACK

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 33342-461-58?

The NDC Packaged Code 33342-461-58 is assigned to a package of 270 capsule in 1 bottle of Pirfenidone Capsule, 267 Mg, a human prescription drug labeled by Macleods Pharmaceuticals Limited. The product's dosage form is capsule and is administered via oral form.

Is NDC 33342-461 included in the NDC Directory?

Yes, Pirfenidone Capsule, 267 Mg with product code 33342-461 is active and included in the NDC Directory. The product was first marketed by Macleods Pharmaceuticals Limited on July 20, 2020 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 33342-461-58?

The 11-digit format is 33342046158. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	33342-461-58	5-4-2	33342-0461-58

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