Dorzolamide Hydrochloride Ophthalmic Solution
NDC Package 71921-400-10

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

Package Information

Dorzolamide Hydrochloride Ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. This formulation utilizes a solution delivery system. Marketed by Florida Pharmaceutical Products, Llc, this product is identified by NDC 71921-400 and is authorized under FDA application ANDA202053.

Identification & Billing

NDC Package Code
71921-400-10
Package Description
10 mL in 1 BOTTLE
Product Code
71921-400
11-Digit Billing Format
71921040010
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
10 ML

Clinical Specifications

Proprietary Name
Dorzolamide Hydrochloride Ophthalmic
Non-Proprietary Name
Dorzolamide Hydrochloride Ophthalmic
Substance Name
Dorzolamide Hydrochloride
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
DORZOLAMIDE HYDROCHLORIDE 20 mg/mL
Pharmacologic Class
Usage Information
Dorzolamide hydrochloride ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

Regulatory & Marketing

Labeler Name
Florida Pharmaceutical Products, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA202053
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-07-2025
Listing Expiration
12-31-2027
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 71921-400-10 identifies a specific commercial package of 10 ml in 1 bottle of Dorzolamide Hydrochloride Ophthalmic, a human prescription drug labeled by Florida Pharmaceutical Products, Llc. This solution is formulated for ophthalmic use and contains dorzolamide hydrochloride 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 Florida Pharmaceutical Products, Llc on May 07, 2025. The current certification is valid through December 31, 2027.

How is this Florida Pharmaceutical Products, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71921040010. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 10 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)
71921-400-10
11-Digit CMS (5-4-2)
71921-0400-10

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