Zolymbus Gel
NDC Package 82584-010-35

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

Zolymbus (bimatoprost) gel is bimatoprost is used to treat high pressure inside the eye due to glaucoma (open-angle type) or other eye diseases (e.g., ocular hypertension). This formulation utilizes a gel delivery system. Marketed by Thea Pharma Inc., this product is identified by NDC 82584-010 and is authorized under FDA application NDA217307.

Identification & Billing

NDC Package Code
82584-010-35
Package Description
3 POUCH in 1 CARTON / 10 VIAL, SINGLE-DOSE in 1 POUCH / .3 g in 1 VIAL, SINGLE-DOSE
Product Code
82584-010
11-Digit Billing Format
82584001035
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Zolymbus
Non-Proprietary Name
Bimatoprost
Substance Name
Bimatoprost
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
BIMATOPROST .1 mg/g
Pharmacologic Class
Usage Information
Bimatoprost 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 can help prevent blindness. This medication works by regulating the flow of fluid within the eye to maintain a normal pressure.

Regulatory & Marketing

Labeler Name
Thea Pharma Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA217307
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-26-2026
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 (82584-010). Click a package code to view its specific billing and regulatory data.

82584-010-10
1 POUCH in 1 CARTON / 10 VIAL, SINGLE-DOSE in 1 POUCH / .3 g in 1 VIAL, SINGLE-DOSE
82584-010-30
3 POUCH in 1 CARTON / 10 VIAL, SINGLE-DOSE in 1 POUCH (82584-010-81) / .3 g in 1 VIAL, SINGLE-DOSE

* 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 82584-010-35 identifies a specific commercial package of 3 pouch in 1 carton / 10 vial, single-dose in 1 pouch / .3 g in 1 vial, single-dose of Zolymbus, a human prescription drug labeled by Thea Pharma Inc.. This gel is formulated for ophthalmic use and contains bimatoprost 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 Thea Pharma Inc. on February 26, 2026. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Bimatoprost 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 can help prevent blindness. This medication works by regulating the flow of fluid within the eye to maintain a normal pressure.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82584001035. 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)
82584-010-35
11-Digit CMS (5-4-2)
82584-0010-35

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