Simbrinza Suspension/ Drops
NDC Package 0065-4147-27

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

Simbrinza (brinzolamide/brimonidine tartrate) suspension/ dropses is this product contains two medications used to treat high pressure in the eye due to glaucoma (open-angle glaucoma-type) or a certain other eye disease (ocular hypertension). This formulation utilizes a suspension/ drops delivery system. Marketed by Alcon Laboratories, Inc., this product is identified by NDC 0065-4147 and is authorized under FDA application NDA204251.

Identification & Billing

NDC Package Code
0065-4147-27
Package Description
1 BOTTLE, DROPPER in 1 CARTON / 8 mL in 1 BOTTLE, DROPPER
Product Code
0065-4147
11-Digit Billing Format
00065414727
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 1421451 - brinzolamide 1 % / brimonidine tartrate 0.2 % Ophthalmic Suspension
  • RxCUI: 1421451 - brimonidine tartrate 2 MG/ML / brinzolamide 10 MG/ML Ophthalmic Suspension
  • RxCUI: 1421451 - brimonidine tartrate 0.2 % / brinzolamide 1 % Ophthalmic Suspension
  • RxCUI: 1421456 - SIMBRINZA 1 % / 0.2 % Ophthalmic Suspension
  • RxCUI: 1421456 - brimonidine tartrate 2 MG/ML / brinzolamide 10 MG/ML Ophthalmic Suspension [Simbrinza]

Clinical Specifications

Proprietary Name
Simbrinza
Non-Proprietary Name
Brinzolamide/brimonidine Tartrate
Substance Name
Brimonidine Tartrate; Brinzolamide
Dosage Form
Suspension/ Drops - A suspension which is usually administered in a dropwise fashion.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
Pharmacologic Class
Usage Information
This product contains two medications used to treat high pressure in the eye due to glaucoma (open-angle glaucoma-type) or a certain other eye disease (ocular hypertension). Lowering high pressure in the eye reduces the risk of vision loss, nerve damage, or blindness. This product contains brinzolamide and brimonidine. These two medications work together to decrease the amount of fluid within the eye. Brinzolamide belongs to a class of drugs known as carbonic anhydrase inhibitors. Brimonidine belongs to a class of drugs known as alpha agonists. This product is not recommended for use in children younger 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
Alcon Laboratories, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA204251
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-06-2013
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 (0065-4147). Click a package code to view its specific billing and regulatory data.

0065-4147-25
1 BOTTLE, DROPPER in 1 CARTON / 2.5 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 0065-4147-27 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 8 ml in 1 bottle, dropper of Simbrinza, a human prescription drug labeled by Alcon Laboratories, Inc.. This suspension/ drops is formulated for ophthalmic use and contains brimonidine tartrate; 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 Alcon Laboratories, Inc. on May 06, 2013. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This product contains two medications used to treat high pressure in the eye due to glaucoma (open-angle glaucoma-type) or a certain other eye disease (ocular hypertension). Lowering high pressure in the eye reduces the risk of vision loss, nerve damage, or blindness. This product contains brinzolamide and brimonidine. These two medications work together to decrease the amount of fluid within the eye. Brinzolamide belongs to a class of drugs known as carbonic anhydrase inhibitors. Brimonidine belongs to a class of drugs known as alpha agonists. This product is not recommended for use in children younger 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 Alcon Laboratories, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00065414727. 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 (4-4-2)
0065-4147-27
11-Digit CMS (5-4-2)
00065-4147-27

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