Bromsite Solution/ Drops
NDC Package 49708-754-41

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

Package Information

Bromsite (bromfenac) solution/ dropses is a medication used to treat swelling (inflammation) and pain in the eye after a certain type of eye surgery (cataract surgery). This formulation utilizes a solution/ drops delivery system. Marketed by Sun Pharmaceutical Industries, Inc., this product is identified by NDC 49708-754 and is authorized under FDA application NDA206911.

Identification & Billing

NDC Package Code
49708-754-41
Package Description
1 POUCH in 1 CARTON / 1 BOTTLE, DROPPER in 1 POUCH / 5 mL in 1 BOTTLE, DROPPER
Product Code
49708-754
11-Digit Billing Format
49708075441
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Bromsite 0.075%
Non-Proprietary Name
Bromfenac
Substance Name
Bromfenac Sodium
Dosage Form
Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
BROMFENAC SODIUM .76 mg/mL
Pharmacologic Class
Usage Information
This medication is used to treat swelling (inflammation) and pain in the eye after a certain type of eye surgery (cataract surgery). Bromfenac belongs to a class of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs). It works by blocking the effects of certain natural substances (prostaglandins) that cause pain and inflammation.

Regulatory & Marketing

Labeler Name
Sun Pharmaceutical Industries, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA206911
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-01-2016
Listing Expiration
12-31-2027
Exclude Flag
N
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 49708-754-41 identifies a specific commercial package of 1 pouch in 1 carton / 1 bottle, dropper in 1 pouch / 5 ml in 1 bottle, dropper of Bromsite 0.075%, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. This solution/ drops is formulated for ophthalmic use and contains bromfenac sodium 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 Sun Pharmaceutical Industries, Inc. on May 01, 2016. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to treat swelling (inflammation) and pain in the eye after a certain type of eye surgery (cataract surgery). Bromfenac belongs to a class of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs). It works by blocking the effects of certain natural substances (prostaglandins) that cause pain and inflammation.

How is this Sun Pharmaceutical Industries, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49708075441. 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)
49708-754-41
11-Digit CMS (5-4-2)
49708-0754-41

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