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  5. NDC Package Code: 50814-016-01 Refill 2

NDC Package 50814-016-01 Refill 2

Benzalkonium Chloride,Bacitracin Zinc,Neomycin Sulfate,Polymyxin B Sulfate Kit - 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:
50814-016-01
Package Description:
1 KIT in 1 KIT * 1 BOX in 1 BOX (50814-013-01) / 10 PACKET in 1 BOX / .9 g in 1 PACKET * 2 BOX in 1 BOX (50814-011-01) / 10 PATCH in 1 BOX / .9 g in 1 PATCH
Product Code:
50814-016
Proprietary Name:
Refill 2
Non-Proprietary Name:
Benzalkonium Chloride, Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate
Usage Information:
• Clean the affected area. • Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily. • May be covered with a sterile bandage.
11-Digit NDC Billing Format:
50814001601
NDC to RxNorm Crosswalk:
  • RxCUI: 1038558 - benzalkonium chloride 0.13 % Medicated Pad
  • RxCUI: 1038558 - benzalkonium chloride 1.3 MG/ML Medicated Pad
  • RxCUI: 1038558 - benzalkonium chloride 0.13 % Topical Swab
  • RxCUI: 1038558 - benzalkonium chloride 0.13 GM per 100 GM Topical Pad
  • RxCUI: 1038558 - benzalkonium chloride 0.13 GM per 100 GM Topical Swab
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Gfa Production (xiamen) Co., Ltd.
    Dosage Form:
    Kit - A packaged collection of related material.
    Sample Package:
    No
    FDA Application Number:
    part333B
    Marketing Category:
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date:
    08-10-2016
    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 50814-016-01?

    The NDC Packaged Code 50814-016-01 is assigned to a package of 1 kit in 1 kit * 1 box in 1 box (50814-013-01) / 10 packet in 1 box / .9 g in 1 packet * 2 box in 1 box (50814-011-01) / 10 patch in 1 box / .9 g in 1 patch of Refill 2, a human over the counter drug labeled by Gfa Production (xiamen) Co., Ltd.. The product's dosage form is kit and is administered via form.

    Is NDC 50814-016 included in the NDC Directory?

    Yes, Refill 2 with product code 50814-016 is active and included in the NDC Directory. The product was first marketed by Gfa Production (xiamen) Co., Ltd. on August 10, 2016 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 50814-016-01?

    The 11-digit format is 50814001601. 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
    5-3-250814-016-015-4-250814-0016-01