NDC Package 61314-665-10 Apraclonidine

Solution Ophthalmic - View Billable Units, 11-Digit Format, RxNorm

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:
61314-665-10
Package Description:
10 mL in 1 BOTTLE
Product Code:
Proprietary Name:
Apraclonidine
Non-Proprietary Name:
Apraclonidine
Substance Name:
Apraclonidine Hydrochloride
Usage Information:
Apraclonidine Ophthalmic Solution, 0.5% as base is indicated for short-term adjunctive therapy in patients on maximally tolerated medical therapy who require additional IOP reduction. Patients on maximally tolerated medical therapy who are treated with Apraclonidine Ophthalmic Solution to delay surgery should have frequent followup examinations and treatment should be discontinued if the intraocular pressure rises significantly.The addition of Apraclonidine Ophthalmic Solution to patients already using two aqueous suppressing drugs (i.e., beta-blocker plus carbonic anhydrase inhibitor) as part of their maximally tolerated medical therapy may not provide additional benefit. This is because Apraclonidine Ophthalmic Solution is an aqueous suppressing drug and the addition of a third aqueous suppressant may not significantly reduce IOP.The IOP lowering efficacy of Apraclonidine Ophthalmic Solution diminishes over time in some patients. This loss of effect, or tachyphylaxis, appears to be an individual occurrence with a variable time of onset and should be closely monitored. The benefit for most patients is less than one month.
11-Digit NDC Billing Format:
61314066510
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
10 ML
NDC to RxNorm Crosswalk:
  • RxCUI: 308345 - apraclonidine HCl 0.5 % Ophthalmic Solution
  • RxCUI: 308345 - apraclonidine 5 MG/ML Ophthalmic Solution
  • RxCUI: 308345 - apraclonidine 0.5 % Ophthalmic Solution
  • RxCUI: 308345 - apraclonidine 5 MG/ML (apraclonidine hydrochloride 5.75 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.
  • Sample Package:
    No
    FDA Application Number:
    NDA020258
    Marketing Category:
    NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
    Start Marketing Date:
    07-19-2009
    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
    61314-665-055 mL in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 61314-665-10?

    The NDC Packaged Code 61314-665-10 is assigned to a package of 10 ml in 1 bottle of Apraclonidine, a human prescription drug labeled by Sandoz Inc. The product's dosage form is solution and is administered via ophthalmic form.

    Is NDC 61314-665 included in the NDC Directory?

    Yes, Apraclonidine with product code 61314-665 is active and included in the NDC Directory. The product was first marketed by Sandoz Inc on July 19, 2009 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 61314-665-10?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 10.

    What is the 11-digit format for NDC 61314-665-10?

    The 11-digit format is 61314066510. 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
    5-3-261314-665-105-4-261314-0665-10