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  5. NDC Package Code: 61314-030-01 Dorzolamide Hydrochloride And Timolol Maleate

NDC Package 61314-030-01 Dorzolamide Hydrochloride And Timolol Maleate

Solution 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:
61314-030-01
Package Description:
5 mL in 1 BOTTLE
Product Code:
61314-030
Proprietary Name:
Dorzolamide Hydrochloride And Timolol Maleate
Non-Proprietary Name:
Dorzolamide Hydrochloride And Timolol Maleate
Substance Name:
Dorzolamide Hydrochloride; Timolol Maleate
Usage Information:
Dorzolamide hydrochloride and timolol maleate ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target IOP determined after multiple measurements over time). The IOP-lowering of dorzolamide hydrochloride and timolol maleate ophthalmic solution administered twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol administered twice a day and 2% dorzolamide administered three times a day [see Clinical Studies (14)].
11-Digit NDC Billing Format:
61314003001
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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Sandoz Inc
    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):
  • 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:
    ANDA090604
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    01-02-2010
    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
    61314-030-0210 mL in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 61314-030-01?

    The NDC Packaged Code 61314-030-01 is assigned to a package of 5 ml in 1 bottle of Dorzolamide Hydrochloride And Timolol Maleate, a human prescription drug labeled by Sandoz Inc. The product's dosage form is solution and is administered via ophthalmic form.

    Is NDC 61314-030 included in the NDC Directory?

    Yes, Dorzolamide Hydrochloride And Timolol Maleate with product code 61314-030 is active and included in the NDC Directory. The product was first marketed by Sandoz Inc on January 02, 2010 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 61314-030-01?

    The 11-digit format is 61314003001. 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
    5-3-261314-030-015-4-261314-0030-01