Dorzolamide Hcl And Timolol Maleate
NDC Package 50090-2867-0

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Dorzolamide Hcl And Timolol Maleate is dorzolamide hydrochloride-timolol maleate ophthalmic solution, USP is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target IOP determined after multiple measurements over time). Marketed by A-s Medication Solutions, this product is identified by NDC 50090-2867 and is authorized under FDA application ANDA202054.

Identification & Billing

NDC Package Code
50090-2867-0
Package Description
1 BOTTLE, DISPENSING in 1 CARTON / 10 mL in 1 BOTTLE, DISPENSING
Product Code
50090-2867
11-Digit Billing Format
50090286700
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 1923432 - dorzolamide HCl 2 % / timolol maleate 0.5 % Ophthalmic Solution
  • RxCUI: 1923432 - dorzolamide 20 MG/ML / timolol 5 MG/ML Ophthalmic Solution
  • RxCUI: 1923432 - dorzolamide 2 % / timolol 0.5 % Ophthalmic Solution
  • RxCUI: 1923432 - dorzolamide 20 MG/ML (as dorzolamide HCl 22.26 MG/ML) / timolol 5 MG/ML (as timolol maleate 6.83 MG/ML) Ophthalmic Solution

Clinical Specifications

Proprietary Name
Dorzolamide Hcl And Timolol Maleate
Dosage Form
-
Usage Information
Dorzolamide hydrochloride-timolol maleate ophthalmic solution, USP is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target IOP determined after multiple measurements over time). The IOP-lowering of dorzolamide hydrochloride-timolol maleate ophthalmic solution, USP administered twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol administered twice a day and 2% dorzolamide administered three times a day [see Clinical Studies (14)].

Regulatory & Marketing

Labeler Name
A-s Medication Solutions
FDA Application #
ANDA202054
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-17-2015
Listing Expiration
12-31-2019
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 50090-2867-0 identifies a specific commercial package of 1 bottle, dispensing in 1 carton / 10 ml in 1 bottle, dispensing of Dorzolamide Hcl And Timolol Maleate, labeled by A-s Medication Solutions. 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 A-s Medication Solutions on February 17, 2015. The current certification is valid through December 31, 2019.

How is this A-s Medication Solutions product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50090286700. 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 (5-4-1)
50090-2867-0
11-Digit CMS (5-4-2)
50090-2867-00

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