Brytly Solution/ Drops
NDC Package 0065-8596-06

11-digit billing NDC: 00065859606
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Brytly (apraclonidine hydrochloride) solution/ dropses is adults and children 12 years of age and over: instill 1 drop in the affected eye(s) every 12 hours do not use more than 2 times dailyremove contact lenses before use wait at least 10 minutes before re-inserting contact lenses after use if using other ophthalmic products when using this product, wait at least 5 minutes between each productto avoid contamination, do not touch tip of container to any surface replace cap after each use children under 12 years of age: Do not use. This formulation utilizes a solution/ drops delivery system. Marketed by Alcon Laboratories, Inc., this product is identified by NDC 0065-8596 and is authorized under FDA application NDA220341.

Identification & Billing

NDC Package Code
0065-8596-06
Package Description
1 BOTTLE in 1 CARTON / .5 mL in 1 BOTTLE
Product Code
0065-8596
11-Digit Billing Format
00065859606

Clinical Specifications

Proprietary Name
Brytly
Non-Proprietary Name
Apraclonidine Hydrochloride
Substance Name
Apraclonidine Hydrochloride
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)
APRACLONIDINE HYDROCHLORIDE 1.25 mg/mL
Pharmacologic Class
Usage Information
Adults and children 12 years of age and over: instill 1 drop in the affected eye(s) every 12 hours do not use more than 2 times dailyremove contact lenses before use wait at least 10 minutes before re-inserting contact lenses after use if using other ophthalmic products when using this product, wait at least 5 minutes between each productto avoid contamination, do not touch tip of container to any surface replace cap after each use children under 12 years of age: Do not use

Regulatory & Marketing

Labeler Name
Alcon Laboratories, Inc.
Product Type
Human Otc Drug
FDA Application #
NDA220341
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-16-2026
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
Yes

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 (0065-8596). Click a package code to view its specific billing and regulatory data.

0065-8596-04
1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE
0065-8596-05
1 BOTTLE in 1 CARTON / 2 mL in 1 BOTTLE

* 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 0065-8596-06 identifies a specific commercial package of 1 bottle in 1 carton / .5 ml in 1 bottle of Brytly, a human over the counter drug labeled by Alcon Laboratories, Inc.. This solution/ drops is formulated for ophthalmic use and contains apraclonidine 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 Alcon Laboratories, Inc. on October 16, 2026. The current certification is valid through December 31, 2027.

How is this Alcon Laboratories, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00065859606. 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)
0065-8596-06
11-Digit CMS (5-4-2)
00065-8596-06

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