Dorzolamide Hydrochloride And Timolol Maleate Ophthalmic Solution Solution/ Drops
NDC Package 42571-147-26

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

Package Information

Dorzolamide Hydrochloride And Timolol Maleate Ophthalmic Solution (dorzolamide hydrochloride and timolol maleate) solution/ dropses is   Dorzolamide hydrochloride and timolol maleate ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open -angle glaucoma or ocular hypertension who are insufficiently responsive to bet a-blockers (failed to achieve target IOP determined after multiple measurements over time). This formulation utilizes a solution/ drops delivery system. Marketed by Micro Labs Limited, this product is identified by NDC 42571-147 and is authorized under FDA application ANDA204777.

Identification & Billing

NDC Package Code
42571-147-26
Package Description
1 BOTTLE in 1 CARTON / 10 mL in 1 BOTTLE
Product Code
42571-147
11-Digit Billing Format
42571014726
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 Hydrochloride And Timolol Maleate Ophthalmic Solution
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
  Dorzolamide hydrochloride and timolol maleate ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open -angle glaucoma or ocular hypertension who are insufficiently responsive to bet a-blockers (failed to achieve target IOP determined after multiple measurements over time). The IOP-lowering of dorzolamide hydrochloride and timolol maleate ophthalmic solution ad ministered twice a day was slightly less than that seen with the concomitant administration of 0.5% ti molol administered twice a day and 2% dorzola mide administered three times a day [see Clinical Studies ( 14)].

Regulatory & Marketing

Labeler Name
Micro Labs Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA204777
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-15-2020
Listing Expiration
12-31-2026
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 42571-147-26 identifies a specific commercial package of 1 bottle in 1 carton / 10 ml in 1 bottle of Dorzolamide Hydrochloride And Timolol Maleate Ophthalmic Solution, a human prescription drug labeled by Micro Labs Limited. 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 Micro Labs Limited on June 15, 2020. The current certification is valid through December 31, 2026.

How is this Micro Labs Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42571014726. 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)
42571-147-26
11-Digit CMS (5-4-2)
42571-0147-26

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