Brimonidine Tartrate Solution/ Drops
NDC Package 42571-419-56

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

Brimonidine Tartrate solution/ dropses is a medication used to treat open-angle glaucoma or high fluid pressure in the eye. This formulation utilizes a solution/ drops delivery system. Marketed by Micro Labs Limited, this product is identified by NDC 42571-419 and is authorized under FDA application ANDA217846.

Identification & Billing

NDC Package Code
42571-419-56
Package Description
1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER
Product Code
42571-419
11-Digit Billing Format
42571041956
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Brimonidine Tartrate
Non-Proprietary Name
Brimonidine Tartrate
Substance Name
Brimonidine Tartrate
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)
BRIMONIDINE TARTRATE 2 mg/mL
Pharmacologic Class
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
Micro Labs Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA217846
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-01-2024
Listing Expiration
12-31-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (42571-419). Click a package code to view its specific billing and regulatory data.

42571-419-57
1 BOTTLE, DROPPER in 1 CARTON / 15 mL in 1 BOTTLE, DROPPER
42571-419-92
1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER

* 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 42571-419-56 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 10 ml in 1 bottle, dropper of Brimonidine Tartrate, a human prescription drug labeled by Micro Labs Limited. This solution/ drops is formulated for ophthalmic use and contains brimonidine tartrate 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 Micro Labs Limited on April 01, 2024. The current certification is valid through December 31, 2026.

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 Micro Labs Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42571041956. 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)
42571-419-56
11-Digit CMS (5-4-2)
42571-0419-56

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