Dorzolamide Hcl
NDC Package 0591-2481-79

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 discontinued by the firm.

Dorzolamide Hcl is dorzolamide is used to treat high pressure inside the eye due to glaucoma (open angle-type) or other eye diseases (e.g., ocular hypertension). Marketed by Actavis Pharma, Inc., this product is identified by NDC 0591-2481 and is authorized under FDA application ANDA202053.

Identification & Billing

NDC Package Code
0591-2481-79
Package Description
1 BOTTLE, DISPENSING in 1 CARTON / 10 mL in 1 BOTTLE, DISPENSING
Product Code
0591-2481
11-Digit Billing Format
00591248179
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Dorzolamide Hcl
Dosage Form
-
Usage Information
Dorzolamide is 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. It belongs to a class of drugs known as carbonic anhydrase inhibitors.

Regulatory & Marketing

Labeler Name
Actavis Pharma, Inc.
FDA Application #
ANDA202053
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-17-2015
End Marketing Date
02-28-2019
Listing Expiration
02-28-2019
Exclude Flag
D
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 0591-2481-79 identifies a specific commercial package of 1 bottle, dispensing in 1 carton / 10 ml in 1 bottle, dispensing of Dorzolamide Hcl, labeled by Actavis 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 Actavis Pharma, Inc. on February 17, 2015. The current certification is valid through February 28, 2019.

What are the primary indications for this medication?

Dorzolamide is 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. It belongs to a class of drugs known as carbonic anhydrase inhibitors.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00591248179. 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 (4-4-2)
0591-2481-79
11-Digit CMS (5-4-2)
00591-2481-79

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