Brinzolamide Powder
NDC Package 58567-101-25

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 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.

Brinzolamide powders is brinzolamide is used to treat high pressure inside the eye due to glaucoma (open angle-type) or other eye diseases (e.g., ocular hypertension). This formulation utilizes a powder delivery system. Marketed by Carbogen Amcis Ag, this product is identified by NDC 58567-101.

Identification & Billing

NDC Package Code
58567-101-25
Package Description
25 kg in 1 DRUM
Product Code
58567-101
11-Digit Billing Format
58567010125

Clinical Specifications

Proprietary Name
Brinzolamide
Non-Proprietary Name
Brinzolamide
Substance Name
Brinzolamide
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)
BRINZOLAMIDE 1 kg/kg
Usage Information
Brinzolamide is used to treat high pressure inside the eye due to glaucoma (open angle-type) or other eye diseases (e.g., ocular hypertension). Lowering high pressure inside the eye helps to prevent blindness. This medication works by decreasing the amount of fluid within the eye. It belongs to a class of drugs known as carbonic anhydrase inhibitors.

Regulatory & Marketing

Labeler Name
Carbogen Amcis Ag
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
04-15-2014
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 58567-101-25 identifies a specific commercial package of 25 kg in 1 drum of Brinzolamide (UNFINISHED drug), a bulk ingredient labeled by Carbogen Amcis Ag. This powder is formulated for use and contains brinzolamide 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 Carbogen Amcis Ag on April 15, 2014. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Brinzolamide is used to treat high pressure inside the eye due to glaucoma (open angle-type) or other eye diseases (e.g., ocular hypertension). Lowering high pressure inside the eye helps to prevent blindness. This medication works by decreasing the amount of fluid within the eye. It belongs to a class of drugs known as carbonic anhydrase inhibitors.

How is this Carbogen Amcis Ag product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58567010125. 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)
58567-101-25
11-Digit CMS (5-4-2)
58567-0101-25

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