Fak Care4 Large Office Refill Bundle7 Kit
NDC Package 50814-034-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Fak Care4 Large Office Refill Bundle7 (benzalkonium chloride) kits is a human otc drug. This formulation utilizes a kit delivery system. Marketed by Gfa Production (xiamen) Co., Ltd., this product is identified by NDC 50814-034 and is authorized under FDA application M003.

Identification & Billing

NDC Package Code
50814-034-01
Package Description
1 KIT in 1 KIT * 2 BOX in 1 BOX (50814-011-01) / 10 PATCH in 1 BOX / .9 g in 1 PATCH
Product Code
50814-034
11-Digit Billing Format
50814003401

Clinical Specifications

Proprietary Name
Fak Care4 Large Office Refill Bundle7
Non-Proprietary Name
Benzalkonium Chloride
Dosage Form
Kit - A packaged collection of related material.

Regulatory & Marketing

Labeler Name
Gfa Production (xiamen) Co., Ltd.
Product Type
Human Otc Drug
FDA Application #
M003
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
02-08-2018
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 50814-034-01 identifies a specific commercial package of 1 kit in 1 kit * 2 box in 1 box (50814-011-01) / 10 patch in 1 box / .9 g in 1 patch of Fak Care4 Large Office Refill Bundle7, a human over the counter drug labeled by Gfa Production (xiamen) Co., Ltd.. This kit is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Gfa Production (xiamen) Co., Ltd. on February 08, 2018. The current certification is valid through December 31, 2026.

How is this Gfa Production (xiamen) Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50814003401. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
50814-034-01
11-Digit CMS (5-4-2)
50814-0034-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.