Difluprednate Powder
NDC Package 46439-8739-2

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.

Difluprednate powders is a medication used to treat swelling and pain after eye surgery. This formulation utilizes a powder delivery system. Marketed by Farmabios S.p.a., this product is identified by NDC 46439-8739.

Identification & Billing

NDC Package Code
46439-8739-2
Package Description
10 g in 1 CARTON
Product Code
46439-8739
11-Digit Billing Format
46439873902

Clinical Specifications

Proprietary Name
Difluprednate
Non-Proprietary Name
Difluprednate
Substance Name
Difluprednate
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)
DIFLUPREDNATE 1 g/g
Usage Information
This medication is used to treat swelling and pain after eye surgery. It may also be used to treat a certain serious eye problem (endogenous anterior uveitis). This medication belongs to a class of drugs known as corticosteroids.

Regulatory & Marketing

Labeler Name
Farmabios S.p.a.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
07-01-2011
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 (46439-8739). Click a package code to view its specific billing and regulatory data.

46439-8739-1
5000 g in 1 DRUM

* 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 46439-8739-2 identifies a specific commercial package of 10 g in 1 carton of Difluprednate (UNFINISHED drug), a bulk ingredient labeled by Farmabios S.p.a.. This powder is formulated for use and contains difluprednate 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 Farmabios S.p.a. on July 01, 2011. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat swelling and pain after eye surgery. It may also be used to treat a certain serious eye problem (endogenous anterior uveitis). This medication belongs to a class of drugs known as corticosteroids.

How is this Farmabios S.p.a. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 46439873902. 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 (5-4-1)
46439-8739-2
11-Digit CMS (5-4-2)
46439-8739-02

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