Brimonidine Tartrate/timolol Maleate Solution/ Drops
NDC Package 68462-281-69

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/timolol Maleate (brimonidine tartrate and timolol maleate) solution/ dropses is brimonidine tartrate/timolol maleate ophthalmic solution 0.2%/0.5% is an alpha-adrenergic receptor agonist with a beta-adrenergic receptor inhibitor indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP; the IOP-lowering of brimonidine tartrate/timolol maleate ophthalmic solution dosed twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol maleate ophthalmic solution dosed twice a day and 0.2% brimonidine tartrate ophthalmic solution dosed three times per day. This formulation utilizes a solution/ drops delivery system. Marketed by Glenmark Pharmaceuticals Inc., Usa, this product is identified by NDC 68462-281 and is authorized under FDA application ANDA214987.

Identification & Billing

NDC Package Code
68462-281-69
Package Description
1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER
Product Code
68462-281
11-Digit Billing Format
68462028169
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 861635 - brimonidine tartrate 0.2 % / timolol maleate 0.5 % Ophthalmic Solution
  • RxCUI: 861635 - brimonidine tartrate 2 MG/ML / timolol 5 MG/ML Ophthalmic Solution
  • RxCUI: 861635 - brimonidine tartrate 0.2 % / timolol 0.5 % (as timolol maleate 6.8 MG/ML) Ophthalmic Solution

Clinical Specifications

Proprietary Name
Brimonidine Tartrate/timolol Maleate
Non-Proprietary Name
Brimonidine Tartrate And Timolol Maleate
Substance Name
Brimonidine Tartrate; Timolol Maleate
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)
Pharmacologic Class
Usage Information
Brimonidine tartrate/timolol maleate ophthalmic solution 0.2%/0.5% is an alpha-adrenergic receptor agonist with a beta-adrenergic receptor inhibitor indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP; the IOP-lowering of brimonidine tartrate/timolol maleate ophthalmic solution dosed twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol maleate ophthalmic solution dosed twice a day and 0.2% brimonidine tartrate ophthalmic solution dosed three times per day.

Regulatory & Marketing

Labeler Name
Glenmark Pharmaceuticals Inc., Usa
Product Type
Human Prescription Drug
FDA Application #
ANDA214987
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-16-2024
Listing Expiration
12-31-2027
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 (68462-281). Click a package code to view its specific billing and regulatory data.

68462-281-32
1 BOTTLE, DROPPER in 1 CARTON / 10 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 68462-281-69 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 5 ml in 1 bottle, dropper of Brimonidine Tartrate/timolol Maleate, a human prescription drug labeled by Glenmark Pharmaceuticals Inc., Usa. This solution/ drops is formulated for ophthalmic use and contains brimonidine tartrate; timolol maleate 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 Glenmark Pharmaceuticals Inc., Usa on May 16, 2024. The current certification is valid through December 31, 2027.

How is this Glenmark Pharmaceuticals Inc., Usa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68462028169. 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 (5-3-2)
68462-281-69
11-Digit CMS (5-4-2)
68462-0281-69

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