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  5. NDC Package Code: 65086-001-05 Verkazia

NDC Package 65086-001-05 Verkazia

Cyclosporine Emulsion Ophthalmic; Topical - 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:
65086-001-05
Package Description:
1 POUCH in 1 CARTON / 5 VIAL, SINGLE-DOSE in 1 POUCH / .3 mL in 1 VIAL, SINGLE-DOSE
Product Code:
65086-001
Proprietary Name:
Verkazia
Non-Proprietary Name:
Cyclosporine
Substance Name:
Cyclosporine
Usage Information:
Cyclosporine eye drops are used to treat a certain type of dry eyes. They work by increasing the amount of tears you make.
11-Digit NDC Billing Format:
65086000105
NDC to RxNorm Crosswalk:
  • RxCUI: 2590608 - cycloSPORINE 0.1 % Ophthalmic Suspension
  • RxCUI: 2590608 - cyclosporine 1 MG/ML Ophthalmic Suspension
  • RxCUI: 2590608 - cyclosporine 0.1 % Ophthalmic Suspension
  • RxCUI: 2590613 - Verkazia 0.1 % Ophthalmic Suspension
  • RxCUI: 2590613 - cyclosporine 1 MG/ML Ophthalmic Suspension [Verkazia]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Santen Incorporated
    Dosage Form:
    Emulsion - A dosage form consisting of a two-phase system comprised of at least two immiscible liquids1, one of which is dispersed as droplets (internal or dispersed phase) within the other liquid (external or continuous phase), generally stabilized with one or more emulsifying agents. (Note: Emulsion is used as a dosage form term unless a more specific term is applicable, e.g. cream, lotion, ointment.)
    Administration Route(s):
  • Ophthalmic - Administration to the external eye.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
    • Active Ingredient(s):
  • CYCLOSPORINE 1 mg/mL
    • Pharmacologic Class(es):
  • Calcineurin Inhibitor Immunosuppressant - [EPC] (Established Pharmacologic Class)
  • Calcineurin Inhibitors - [MoA] (Mechanism of Action)
  • Cytochrome P450 3A4 Inhibitors - [MoA] (Mechanism of Action)
  • P-Glycoprotein Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    Yes
    FDA Application Number:
    NDA214965
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    02-01-2022
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    65086-001-1224 POUCH in 1 CARTON / 5 VIAL, SINGLE-DOSE in 1 POUCH / .3 mL in 1 VIAL, SINGLE-DOSE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 65086-001-05?

    The NDC Packaged Code 65086-001-05 is assigned to a package of 1 pouch in 1 carton / 5 vial, single-dose in 1 pouch / .3 ml in 1 vial, single-dose of Verkazia, a human prescription drug labeled by Santen Incorporated. The product's dosage form is emulsion and is administered via ophthalmic; topical form.

    Is NDC 65086-001 included in the NDC Directory?

    Yes, Verkazia with product code 65086-001 is active and included in the NDC Directory. The product was first marketed by Santen Incorporated on February 01, 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 11-digit format for NDC 65086-001-05?

    The 11-digit format is 65086000105. 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
    5-3-265086-001-055-4-265086-0001-05