Simbrinza
NDC Package 0078-0904-38

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

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Simbrinza 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). Marketed by Novartis Pharmaceuticals Corporation, this product is identified by NDC 0078-0904 and is authorized under FDA application NDA204251.

Identification & Billing

NDC Package Code
0078-0904-38
Package Description
1 BOTTLE in 1 CARTON / 8 mL in 1 BOTTLE
Product Code
0078-0904
11-Digit Billing Format
00078090438

Clinical Specifications

Proprietary Name
Simbrinza
Dosage Form
-
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
Novartis Pharmaceuticals Corporation
FDA Application #
NDA204251
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-01-2013
End Marketing Date
02-28-2023
Listing Expiration
02-28-2023
Exclude Flag
D
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 (0078-0904). Click a package code to view its specific billing and regulatory data.

0078-0904-98
1 BOTTLE in 1 CARTON / 2.5 mL in 1 BOTTLE

* 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 0078-0904-38 identifies a specific commercial package of 1 bottle in 1 carton / 8 ml in 1 bottle of Simbrinza, labeled by Novartis Pharmaceuticals Corporation. 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 Novartis Pharmaceuticals Corporation on May 01, 2013. The current certification is valid through February 28, 2023.

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 Novartis Pharmaceuticals Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00078090438. 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)
0078-0904-38
11-Digit CMS (5-4-2)
00078-0904-38

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