Cosopt Pf Solution/ Drops
NDC Package 82584-604-30

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Cosopt Pf (dorzolamide hydrochloride and timolol maleate) solution/ dropses is this product contains two drugs used to treat high pressure inside the eye due to glaucoma (open angle-type) or other eye diseases (e.g., ocular hypertension). This formulation utilizes a solution/ drops delivery system. Marketed by Thea Pharma Inc., this product is identified by NDC 82584-604 and is authorized under FDA application NDA202667.

Identification & Billing

NDC Package Code
82584-604-30
Package Description
4 POUCH in 1 CARTON / 15 VIAL, SINGLE-DOSE in 1 POUCH (82584-604-01) / .2 mL in 1 VIAL, SINGLE-DOSE
Product Code
82584-604
11-Digit Billing Format
82584060430
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • RxCUI: 1922783 - dorzolamide 2 % / timolol 0.5 % PF Ophthalmic Solution
  • RxCUI: 1922783 - Preservative-Free dorzolamide 20 MG/ML / timolol 5 MG/ML Ophthalmic Solution
  • RxCUI: 1922784 - COSOPT PF 2 % / 0.5 % Ophthalmic Solution
  • RxCUI: 1922784 - Preservative-Free dorzolamide 20 MG/ML / timolol 5 MG/ML Ophthalmic Solution [Cosopt]
  • RxCUI: 1922784 - Cosopt PF (dorzolamide 2 % / timolol 0.5 % ) Ophthalmic Solution

Clinical Specifications

Proprietary Name
Cosopt Pf
Non-Proprietary Name
Dorzolamide Hydrochloride And Timolol Maleate
Substance Name
Dorzolamide Hydrochloride; 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
This product contains two drugs used to treat high pressure inside the eye due to glaucoma (open angle-type) or other eye diseases (e.g., ocular hypertension). Lowering high pressure inside the eye helps to prevent blindness. This medication works by decreasing the amount of fluid within the eye. Timolol belongs to a class of drugs known as beta-blockers, and dorzolamide belongs to a class of drugs known as carbonic anhydrase inhibitors.

Regulatory & Marketing

Labeler Name
Thea Pharma Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA202667
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-10-2022
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 82584-604-30 identifies a specific commercial package of 4 pouch in 1 carton / 15 vial, single-dose in 1 pouch (82584-604-01) / .2 ml in 1 vial, single-dose of Cosopt Pf, a human prescription drug labeled by Thea Pharma Inc.. This solution/ drops is formulated for ophthalmic use and contains dorzolamide hydrochloride; 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 Thea Pharma Inc. on December 10, 2022. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This product contains two drugs used to treat high pressure inside the eye due to glaucoma (open angle-type) or other eye diseases (e.g., ocular hypertension). Lowering high pressure inside the eye helps to prevent blindness. This medication works by decreasing the amount of fluid within the eye. Timolol belongs to a class of drugs known as beta-blockers, and dorzolamide belongs to a class of drugs known as carbonic anhydrase inhibitors.

How is this Thea Pharma Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82584060430. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
82584-604-30
11-Digit CMS (5-4-2)
82584-0604-30

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