NDC Package 0065-1431-28 Systane Ultra

Polyethylene Glycol 400 And Propylene Glycol Solution/ Drops 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:
0065-1431-28
Package Description:
2 BOTTLE, DROPPER in 1 CARTON / 4 mL in 1 BOTTLE, DROPPER
Product Code:
Proprietary Name:
Systane Ultra
Non-Proprietary Name:
Polyethylene Glycol 400 And Propylene Glycol
Substance Name:
Polyethylene Glycol 400; Propylene Glycol
Usage Information:
Shake well before usingĀ  put 1 or 2 drops in the affected eye(s) as needed Shake well before using. shake well before usingput 1 or 2 drops in the affected eye(s) as needed
11-Digit NDC Billing Format:
00065143128
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 477589 - polyethylene glycol 400, 0.4 % / propylene glycol 0.3 % Ophthalmic Solution
  • RxCUI: 477589 - polyethylene glycol 400 4 MG/ML / propylene glycol 3 MG/ML Ophthalmic Solution
  • RxCUI: 477589 - PEG 400 0.4 % / propylene glycol 0.3 % Ophthalmic Solution
  • Product Type:
    Human Otc Drug
    Labeler Name:
    Alcon Laboratories, 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.
  • Sample Package:
    No
    FDA Application Number:
    M018
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    10-01-2014
    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
    0065-1431-011 BOTTLE, DROPPER in 1 CARTON / 1.5 mL in 1 BOTTLE, DROPPER
    0065-1431-051 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER
    0065-1431-183 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER
    0065-1431-211 BOTTLE, DROPPER in 1 CARTON / 3 mL in 1 BOTTLE, DROPPER
    0065-1431-311 BOTTLE, DROPPER in 1 CARTON / 4 mL in 1 BOTTLE, DROPPER
    0065-1431-412 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER
    0065-1431-801 BOTTLE, DROPPER in 1 CARTON / 3 mL in 1 BOTTLE, DROPPER

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0065-1431-28?

    The NDC Packaged Code 0065-1431-28 is assigned to a package of 2 bottle, dropper in 1 carton / 4 ml in 1 bottle, dropper of Systane Ultra, a human over the counter drug labeled by Alcon Laboratories, Inc.. The product's dosage form is solution/ drops and is administered via ophthalmic form.

    Is NDC 0065-1431 included in the NDC Directory?

    Yes, Systane Ultra with product code 0065-1431 is active and included in the NDC Directory. The product was first marketed by Alcon Laboratories, Inc. on October 01, 2014 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 0065-1431-28?

    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 0065-1431-28?

    The 11-digit format is 00065143128. 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 4-4-2 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
    4-4-20065-1431-285-4-200065-1431-28