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  4. NDC Product Code: 50814-016 Refill 2

NDC 50814-016 Refill 2

Benzalkonium Chloride,Bacitracin Zinc,Neomycin Sulfate,Polymyxin B Sulfate Kit - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 50814-016?
  4. Refill 2 Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
50814-016
Proprietary Name:
Refill 2
Non-Proprietary Name: [1]
Benzalkonium Chloride, Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Labeler Name: [5]
Gfa Production (xiamen) Co., Ltd.
Labeler Code:
50814
Product Label ID:
b479c3e9-cccc-4734-87cd-4d7dfc00ca1d
FDA Application Number: [6]
part333B
Marketing Category: [8]
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date: [9]
08-10-2016
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Code Navigator:

Code Structure Chart

Product Details

What is NDC 50814-016?

The NDC code 50814-016 is assigned by the FDA to the product Refill 2 which is a human over the counter drug product labeled by Gfa Production (xiamen) Co., Ltd.. The generic name of Refill 2 is benzalkonium chloride, bacitracin zinc, neomycin sulfate, polymyxin b sulfate. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 50814-016-01 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. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Refill 2?

• 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.

Which are Refill 2 UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Refill 2 Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Refill 2?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

* Please review the disclaimer below.

Product Footnotes

[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".