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  5. NDC Package Code: 65145-164-01 Brimonidine Tartrate/timolol Maleate Ophthalmic Solution

NDC Package 65145-164-01 Brimonidine Tartrate/timolol Maleate Ophthalmic Solution

Brimonidine Tartrate And Timolol Maleate Solution Ophthalmic - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
65145-164-01
Package Description:
1 BOTTLE, DROPPER in 1 CARTON / 15 mL in 1 BOTTLE, DROPPER
Product Code:
65145-164
Proprietary Name:
Brimonidine Tartrate/timolol Maleate Ophthalmic Solution
Non-Proprietary Name:
Brimonidine Tartrate And Timolol Maleate
Substance Name:
Brimonidine Tartrate; Timolol Maleate
Usage Information:
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5% is an alpha-adrenergic receptor agonist with a beta-adrenergic receptor inhibitor indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP; the IOP-lowering of brimonidine tartrate/timolol maleate ophthalmic solution dosed twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol maleate ophthalmic solution dosed twice a day and 0.2% brimonidine tartrate ophthalmic solution dosed three times per day.
11-Digit NDC Billing Format:
65145016401
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 861635 - brimonidine tartrate 0.2 % / timolol maleate 0.5 % Ophthalmic Solution
  • RxCUI: 861635 - brimonidine tartrate 2 MG/ML / timolol 5 MG/ML Ophthalmic Solution
  • RxCUI: 861635 - brimonidine tartrate 0.2 % / timolol 0.5 % (as timolol maleate 6.8 MG/ML) Ophthalmic Solution
Product Type:
Human Prescription Drug
Labeler Name:
Caplin Steriles Limited
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(s):
Ophthalmic - Administration to the external eye.
Active Ingredient(s):
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
ANDA219093
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
03-10-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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 disclaimer below.

Frequently Asked Questions

What is NDC 65145-164-01?

The NDC Packaged Code 65145-164-01 is assigned to a package of 1 bottle, dropper in 1 carton / 15 ml in 1 bottle, dropper of Brimonidine Tartrate/timolol Maleate Ophthalmic Solution, a human prescription drug labeled by Caplin Steriles Limited. The product's dosage form is solution and is administered via ophthalmic form.

Is NDC 65145-164 included in the NDC Directory?

Yes, Brimonidine Tartrate/timolol Maleate Ophthalmic Solution with product code 65145-164 is active and included in the NDC Directory. The product was first marketed by Caplin Steriles Limited on March 10, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 65145-164-01?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

What is the 11-digit format for NDC 65145-164-01?

The 11-digit format is 65145016401. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-265145-164-015-4-265145-0164-01