Dorzolamide Hydrochloride Timolol Maleate
NDC Package 70377-082-11

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 Hydrochloride Timolol Maleate is dorzolamide hydrochloride and 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 and 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)]. Marketed by Biocon Pharma Inc., this product is identified by NDC 70377-082 and is authorized under FDA application ANDA202054.

Identification & Billing

NDC Package Code
70377-082-11
Package Description
1 BOTTLE, DISPENSING in 1 CARTON / 10 mL in 1 BOTTLE, DISPENSING
Product Code
70377-082
11-Digit Billing Format
70377008211
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 Timolol Maleate
Dosage Form
-
Usage Information
Dorzolamide hydrochloride and 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 and 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
Biocon Pharma Inc.
FDA Application #
ANDA202054
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-08-2022
Listing Expiration
12-31-2025
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 70377-082-11 identifies a specific commercial package of 1 bottle, dispensing in 1 carton / 10 ml in 1 bottle, dispensing of Dorzolamide Hydrochloride Timolol Maleate, labeled by Biocon Pharma Inc.. 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 Biocon Pharma Inc. on January 08, 2022. The current certification is valid through December 31, 2025.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70377008211. 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)
70377-082-11
11-Digit CMS (5-4-2)
70377-0082-11

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