Cosopt Pf
NDC Package 17478-604-15

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 inactivated by the FDA.

Cosopt Pf 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). Marketed by Akorn, this product is identified by NDC 17478-604 and is authorized under FDA application NDA202667.

Identification & Billing

NDC Package Code
17478-604-15
Package Description
2 POUCH in 1 CARTON / 15 VIAL, SINGLE-USE in 1 POUCH (17478-604-00) / .2 mL in 1 VIAL, SINGLE-USE
Product Code
17478-604
11-Digit Billing Format
17478060415
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
Dosage Form
-
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
Akorn
FDA Application #
NDA202667
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-14-2014
Listing Expiration
12-31-2023
Exclude Flag
I
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 (17478-604). Click a package code to view its specific billing and regulatory data.

17478-604-30
4 POUCH in 1 CARTON / 15 VIAL, SINGLE-USE in 1 POUCH (17478-604-01) / .2 mL in 1 VIAL, SINGLE-USE
17478-604-90
12 POUCH in 1 CARTON / 15 VIAL, SINGLE-USE in 1 POUCH (17478-604-01) / .2 mL in 1 VIAL, SINGLE-USE

* 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 17478-604-15 identifies a specific commercial package of 2 pouch in 1 carton / 15 vial, single-use in 1 pouch (17478-604-00) / .2 ml in 1 vial, single-use of Cosopt Pf, labeled by Akorn. 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 Akorn on May 14, 2014. The current certification is valid through December 31, 2023.

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 Akorn product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17478060415. 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)
17478-604-15
11-Digit CMS (5-4-2)
17478-0604-15

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