Bromfenac
NDC Package 50383-249-71

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 inactivated by the FDA.

Bromfenac is ophthalmic Solution 0.09% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. Marketed by Akorn, this product is identified by NDC 50383-249 and is authorized under FDA application ANDA203395.

Identification & Billing

NDC Package Code
50383-249-71
Package Description
1 BOTTLE, DROPPER in 1 CARTON / 1.7 mL in 1 BOTTLE, DROPPER
Product Code
50383-249
11-Digit Billing Format
50383024971
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Bromfenac
Dosage Form
-
Usage Information
Bromfenac Ophthalmic Solution 0.09% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.

Regulatory & Marketing

Labeler Name
Akorn
FDA Application #
ANDA203395
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-22-2014
Listing Expiration
12-31-2023
Exclude Flag
I
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 50383-249-71 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 1.7 ml in 1 bottle, dropper of Bromfenac, labeled by Akorn. 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 Akorn on January 22, 2014. The current certification is valid through December 31, 2023.

How is this Akorn product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50383024971. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
50383-249-71
11-Digit CMS (5-4-2)
50383-0249-71

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