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  5. NDC Package Code: 62332-553-10 Dorzolamide Hydrochloride And Timolol Maleate Ophthalmic Solution

NDC Package 62332-553-10 Dorzolamide Hydrochloride And Timolol Maleate Ophthalmic Solution

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:
62332-553-10
Package Description:
1 BOTTLE in 1 CARTON / 10 mL in 1 BOTTLE
Product Code:
62332-553
Proprietary Name:
Dorzolamide Hydrochloride And Timolol Maleate Ophthalmic Solution
Non-Proprietary Name:
Dorzolamide Hydrochloride And Timolol Maleate Ophthalmic Solution
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:
62332055310
NDC to RxNorm Crosswalk:
  • RxCUI: 1922783 - dorzolamide 2 % / timolol 0.5 % PF Ophthalmic Solution
  • RxCUI: 1922783 - Preservative-Free dorzolamide 20 MG/ML / timolol 5 MG/ML Ophthalmic Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Alembic 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):
  • 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:
    ANDA213099
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    05-04-2021
    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 62332-553-10?

    The NDC Packaged Code 62332-553-10 is assigned to a package of 1 bottle in 1 carton / 10 ml in 1 bottle of Dorzolamide Hydrochloride And Timolol Maleate Ophthalmic Solution, a human prescription drug labeled by Alembic Pharmaceuticals Inc.. The product's dosage form is solution/ drops and is administered via ophthalmic form.

    Is NDC 62332-553 included in the NDC Directory?

    Yes, Dorzolamide Hydrochloride And Timolol Maleate Ophthalmic Solution with product code 62332-553 is active and included in the NDC Directory. The product was first marketed by Alembic Pharmaceuticals Inc. on May 04, 2021 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 62332-553-10?

    The 11-digit format is 62332055310. 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
    5-3-262332-553-105-4-262332-0553-10