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  5. NDC Package Code: 69315-304-10 Dorzolamide Hydrochloride

NDC Package 69315-304-10 Dorzolamide Hydrochloride

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:
69315-304-10
Package Description:
1 BOTTLE in 1 CARTON / 10 mL in 1 BOTTLE
Product Code:
69315-304
Proprietary Name:
Dorzolamide Hydrochloride
Non-Proprietary Name:
Dorzolamide Hydrochloride
Substance Name:
Dorzolamide Hydrochloride
11-Digit NDC Billing Format:
69315030410
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 310015 - dorzolamide HCl 2 % Ophthalmic Solution
  • RxCUI: 310015 - dorzolamide 20 MG/ML Ophthalmic Solution
  • RxCUI: 310015 - dorzolamide 2 % Ophthalmic Solution
  • RxCUI: 310015 - dorzolamide 20 MG/ML (as dorzolamide HCl 22.3 MG/ML) Ophthalmic Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Leading Pharma, Llc
    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
    • Pharmacologic Class(es):
  • Carbonic Anhydrase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Carbonic Anhydrase Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA205294
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    12-01-2019
    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
    69315-304-051 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 69315-304-10?

    The NDC Packaged Code 69315-304-10 is assigned to a package of 1 bottle in 1 carton / 10 ml in 1 bottle of Dorzolamide Hydrochloride, a human prescription drug labeled by Leading Pharma, Llc. The product's dosage form is solution and is administered via ophthalmic form.

    Is NDC 69315-304 included in the NDC Directory?

    Yes, Dorzolamide Hydrochloride with product code 69315-304 is active and included in the NDC Directory. The product was first marketed by Leading Pharma, Llc on December 01, 2019 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 69315-304-10?

    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 69315-304-10?

    The 11-digit format is 69315030410. 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
    5-3-269315-304-105-4-269315-0304-10