Brimonidine Tartrate
NDC Package 16590-883-10

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.

Brimonidine Tartrate is a medication used to treat open-angle glaucoma or high fluid pressure in the eye. Marketed by Stat Rx Usa Llc, this product is identified by NDC 16590-883 and is authorized under FDA application ANDA076260.

Identification & Billing

NDC Package Code
16590-883-10
Package Description
10 mL in 1 BOTTLE, DROPPER
Product Code
16590-883
11-Digit Billing Format
16590088310

Clinical Specifications

Proprietary Name
Brimonidine Tartrate
Dosage Form
-
Usage Information
This medication is used to treat open-angle glaucoma or high fluid pressure in the eye. Lowering high fluid pressure in the eye reduces the risk of vision loss, nerve damage, or blindness. This medication lowers pressure by allowing better fluid drainage from within the eye and also by reducing the amount of fluid formed in the eye. It is known as an alpha agonist. This drug is not recommended for use in children less than 2 years of age due to an increased risk of serious side effects such as very slowed breathing. Ask the doctor or pharmacist for details.

Regulatory & Marketing

Labeler Name
Stat Rx Usa Llc
FDA Application #
ANDA076260
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-28-2003
Listing Expiration
12-31-2017
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 16590-883-10 identifies a specific commercial package of 10 ml in 1 bottle, dropper of Brimonidine Tartrate, labeled by Stat Rx Usa Llc. 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 Stat Rx Usa Llc on May 28, 2003. The current certification is valid through December 31, 2017.

What are the primary indications for this medication?

This medication is used to treat open-angle glaucoma or high fluid pressure in the eye. Lowering high fluid pressure in the eye reduces the risk of vision loss, nerve damage, or blindness. This medication lowers pressure by allowing better fluid drainage from within the eye and also by reducing the amount of fluid formed in the eye. It is known as an alpha agonist. This drug is not recommended for use in children less than 2 years of age due to an increased risk of serious side effects such as very slowed breathing. Ask the doctor or pharmacist for details.

How is this Stat Rx Usa Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16590088310. 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)
16590-883-10
11-Digit CMS (5-4-2)
16590-0883-10

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