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  5. NDC Package Code: 72485-634-10 Brimonidine Tartrate/timolol Maleate

NDC Package 72485-634-10 Brimonidine Tartrate/timolol Maleate

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

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
72485-634-10
Package Description:
1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER
Product Code:
72485-634
Proprietary Name:
Brimonidine Tartrate/timolol Maleate
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:
72485063410
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 % Ophthalmic Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Armas Pharmaceuticals Inc
    Dosage Form:
    Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
    Administration Route(s):
  • Ophthalmic - Administration to the external eye.
    • Active Ingredient(s):
  • BRIMONIDINE TARTRATE 2 mg/mL
  • TIMOLOL MALEATE 5 mg/mL
    • Pharmacologic Class(es):
  • Adrenergic alpha-Agonists - [MoA] (Mechanism of Action)
  • Adrenergic beta-Antagonists - [MoA] (Mechanism of Action)
  • alpha-Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
  • beta-Adrenergic Blocker - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA201949
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    11-03-2023
    Listing Expiration Date:
    12-31-2024
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    72485-634-051 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 72485-634-10?

    The NDC Packaged Code 72485-634-10 is assigned to a package of 1 bottle, dropper in 1 carton / 10 ml in 1 bottle, dropper of Brimonidine Tartrate/timolol Maleate, a human prescription drug labeled by Armas Pharmaceuticals Inc. The product's dosage form is solution/ drops and is administered via ophthalmic form.

    Is NDC 72485-634 included in the NDC Directory?

    Yes, Brimonidine Tartrate/timolol Maleate with product code 72485-634 is active and included in the NDC Directory. The product was first marketed by Armas Pharmaceuticals Inc on November 03, 2023 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 72485-634-10?

    The 11-digit format is 72485063410. 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
    5-3-272485-634-105-4-272485-0634-10