Timolol Maleate Ophthalmic Gel Forming Solution Solution, Gel Forming / Drops
NDC Package 68083-458-01

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

Package Information

Timolol Maleate Ophthalmic Gel Forming Solution (timolol maleate ophthalmic gel forming) solution is a medication 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 solution, gel forming / drops delivery system. Marketed by Gland Pharma Limited, this product is identified by NDC 68083-458 and is authorized under FDA application ANDA214645.

Identification & Billing

NDC Package Code
68083-458-01
Package Description
1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE
Product Code
68083-458
11-Digit Billing Format
68083045801
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Timolol Maleate Ophthalmic Gel Forming Solution
Non-Proprietary Name
Timolol Maleate Ophthalmic Gel Forming
Substance Name
Timolol Maleate
Dosage Form
Solution, Gel Forming / Drops - A solution, which after usually being administered in a drop-wise fashion, forms a gel.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
TIMOLOL MALEATE 5 mg/mL
Pharmacologic Class
Usage Information
This medication 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. Timolol belongs to a class of drugs known as beta-blockers.

Regulatory & Marketing

Labeler Name
Gland Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA214645
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-14-2023
Listing Expiration
12-31-2026
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 68083-458-01 identifies a specific commercial package of 1 bottle in 1 carton / 5 ml in 1 bottle of Timolol Maleate Ophthalmic Gel Forming Solution, a human prescription drug labeled by Gland Pharma Limited. This solution, gel forming / drops is formulated for ophthalmic use and contains timolol maleate 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 Gland Pharma Limited on February 14, 2023. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication 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. Timolol belongs to a class of drugs known as beta-blockers.

How is this Gland Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68083045801. 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)
68083-458-01
11-Digit CMS (5-4-2)
68083-0458-01

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