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  4. NDC Product Code: 49873-019 Keepan A

NDC 49873-019 Keepan A

Benzalkonium Chloride,Lidocaine Hydrochloride Spray Topical - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 49873-019?
  4. Keepan A Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes

Product Information

NDC Product Code:
49873-019
Proprietary Name:
Keepan A
Non-Proprietary Name: [1]
Benzalkonium Chloride, Lidocaine Hydrochloride
Substance Name: [2]
Benzalkonium Chloride; Lidocaine Hydrochloride
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Spray - A liquid minutely divided as by a jet of air or steam.
Administration Route(s): [4]
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
    • Labeler Name: [5]
    Sato Pharmaceutical Co., Ltd.
    Labeler Code:
    49873
    Product Label ID:
    a30679d5-5507-499d-9d9f-498095fd32ac
    FDA Application Number: [6]
    part333A
    Marketing Category: [8]
    OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
    Start Marketing Date: [9]
    07-15-1981
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Code Structure Chart

    Product Details

    What is NDC 49873-019?

    The NDC code 49873-019 is assigned by the FDA to the product Keepan A which is a human over the counter drug product labeled by Sato Pharmaceutical Co., Ltd.. The generic name of Keepan A is benzalkonium chloride, lidocaine hydrochloride. The product's dosage form is spray and is administered via topical form. The product is distributed in a single package with assigned NDC code 49873-019-01 1 bottle, spray in 1 carton / 60 ml in 1 bottle, spray. 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 Keepan A?

    Uses  First aid for minor cuts, scrapes and burns:■ to help reduce the risk of infection■ for the temporary relief of pain and itching

    What are Keepan A Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    Which are Keepan A UNII Codes?

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

    Which are Keepan A 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 Keepan A?

    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:
    • RxCUI: 1246623 - benzalkonium chloride 0.1 % / lidocaine HCl 1 % Topical Spray
    • RxCUI: 1246623 - benzalkonium chloride 1 MG/ML / lidocaine hydrochloride 10 MG/ML Topical Spray
    • RxCUI: 1246623 - benzalkonium chloride 0.1 % / lidocaine hydrochloride 1 % Topical Spray
    • RxCUI: 1246628 - KEEPAN A 0.1 % / 1 % Topical Spray
    • RxCUI: 1246628 - benzalkonium chloride 1 MG/ML / lidocaine hydrochloride 10 MG/ML Topical Spray [Keepan]

    Which are the Pharmacologic Classes for Keepan A?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of 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.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [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".