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  5. NDC Package Code: 82584-605-10 Cosopt

NDC Package 82584-605-10 Cosopt

Dorzolamide Hydrochloride And Timolol Maleate Solution/ Drops 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:
82584-605-10
Package Description:
1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER
Product Code:
82584-605
Proprietary Name:
Cosopt
Non-Proprietary Name:
Dorzolamide Hydrochloride And Timolol Maleate
Substance Name:
Dorzolamide Hydrochloride; Timolol Maleate
Usage Information:
This product contains two drugs 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, and dorzolamide belongs to a class of drugs known as carbonic anhydrase inhibitors.
11-Digit NDC Billing Format:
82584060510
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1923432 - dorzolamide HCl 2 % / timolol maleate 0.5 % Ophthalmic Solution
  • RxCUI: 1923432 - dorzolamide 20 MG/ML / timolol 5 MG/ML Ophthalmic Solution
  • RxCUI: 1923432 - dorzolamide 2 % / timolol 0.5 % Ophthalmic Solution
  • RxCUI: 1923432 - dorzolamide 20 MG/ML (as dorzolamide HCl 22.26 MG/ML) / timolol 5 MG/ML (as timolol maleate 6.83 MG/ML) Ophthalmic Solution
  • RxCUI: 1923433 - COSOPT 2 % / 0.5 % Ophthalmic Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Thea Pharma 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):
  • DORZOLAMIDE HYDROCHLORIDE 20 mg/mL
  • TIMOLOL MALEATE 5 mg/mL
    • Pharmacologic Class(es):
  • Adrenergic beta-Antagonists - [MoA] (Mechanism of Action)
  • Carbonic Anhydrase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Carbonic Anhydrase Inhibitors - [MoA] (Mechanism of Action)
  • beta-Adrenergic Blocker - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    NDA020869
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    11-10-2022
    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.

    Frequently Asked Questions

    What is NDC 82584-605-10?

    The NDC Packaged Code 82584-605-10 is assigned to a package of 1 bottle, dropper in 1 carton / 10 ml in 1 bottle, dropper of Cosopt, a human prescription drug labeled by Thea Pharma Inc.. The product's dosage form is solution/ drops and is administered via ophthalmic form.

    Is NDC 82584-605 included in the NDC Directory?

    Yes, Cosopt with product code 82584-605 is active and included in the NDC Directory. The product was first marketed by Thea Pharma Inc. on November 10, 2022 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 NDC billing unit for package 82584-605-10?

    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 82584-605-10?

    The 11-digit format is 82584060510. 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
    5-3-282584-605-105-4-282584-0605-10