Dorzolamide Hydrochloride And Timolol Maleate Preservative Free Solution/ Drops
NDC Package 65862-947-60

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

Dorzolamide Hydrochloride And Timolol Maleate Preservative Free solution/ dropses is dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free 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). This formulation utilizes a solution/ drops delivery system. Marketed by Aurobindo Pharma Limited, this product is identified by NDC 65862-947 and is authorized under FDA application ANDA207630.

Identification & Billing

NDC Package Code
65862-947-60
Package Description
4 POUCH in 1 CARTON / 15 VIAL, SINGLE-USE in 1 POUCH (65862-947-15) / .2 mL in 1 VIAL, SINGLE-USE
Product Code
65862-947
11-Digit Billing Format
65862094760
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

Clinical Specifications

Proprietary Name
Dorzolamide Hydrochloride And Timolol Maleate Preservative Free
Non-Proprietary Name
Dorzolamide Hydrochloride And Timolol Maleate Preservative Free
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 preservative free 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 and timolol maleate ophthalmic solution 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 (14.1)].

Regulatory & Marketing

Labeler Name
Aurobindo Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA207630
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-24-2018
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (65862-947). Click a package code to view its specific billing and regulatory data.

65862-947-18
12 POUCH in 1 CARTON / 15 VIAL, SINGLE-USE in 1 POUCH / .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 65862-947-60 identifies a specific commercial package of 4 pouch in 1 carton / 15 vial, single-use in 1 pouch (65862-947-15) / .2 ml in 1 vial, single-use of Dorzolamide Hydrochloride And Timolol Maleate Preservative Free, a human prescription drug labeled by Aurobindo Pharma 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 Aurobindo Pharma Limited on July 24, 2018. The current certification is valid through December 31, 2026.

How is this Aurobindo Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65862094760. 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)
65862-947-60
11-Digit CMS (5-4-2)
65862-0947-60

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