NDC 57893-302 Vytone

Hydrocortisone Acetate,Iodoquinol Cream Topical - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
57893-302
Proprietary Name:
Vytone
Non-Proprietary Name: [1]
Hydrocortisone Acetate, Iodoquinol
Substance Name: [2]
Hydrocortisone Acetate; Iodoquinol
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
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]
    Artesa Labs, Llc
    Labeler Code:
    57893
    Marketing Category: [8]
    UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
    Start Marketing Date: [9]
    07-29-2011
    End Marketing Date: [10]
    01-31-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    GREEN (C48329)

    Product Packages

    NDC Code 57893-302-10

    Package Description: 10 PACKET in 1 CARTON / 2 g in 1 PACKET (57893-302-01)

    NDC Code 57893-302-30

    Package Description: 30 PACKET in 1 CARTON / 2 g in 1 PACKET (57893-302-01)

    Product Details

    What is NDC 57893-302?

    The NDC code 57893-302 is assigned by the FDA to the product Vytone which is a human prescription drug product labeled by Artesa Labs, Llc. The generic name of Vytone is hydrocortisone acetate, iodoquinol. The product's dosage form is cream and is administered via topical form. The product is distributed in 2 packages with assigned NDC codes 57893-302-10 10 packet in 1 carton / 2 g in 1 packet (57893-302-01), 57893-302-30 30 packet in 1 carton / 2 g in 1 packet (57893-302-01). 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 Vytone?

    Based on a review of a related drug by the National Research Council and subsequent FDA classification for that drug, the indications are as follows: “Possibly” Effective: Contact or atopic dermatitis; impetiginized eczema; nummular eczema; endogenous chronic infectious dermatitis; stasis dermatitis; pyoderma; nuchal eczema and chronic eczematoid otitis externa; acne urticata; localized or disseminated neurodermatitis; lichen simplex chronicus; anogenital pruritus (vulvae, scroti, ani); folliculitis; bacterial dermatoses; mycotic dermatoses such as tinea (capitis, cruris, corporis, pedis); monliasis; intertrigo. Final classification of the less-than-effective indications requires further investigation.

    What are Vytone 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.
    • HYDROCORTISONE ACETATE 19 mg/g
    • IODOQUINOL 10 mg/g - One of the halogenated 8-quinolinols widely used as an intestinal antiseptic, especially as an antiamebic agent. It is also used topically in other infections and may cause CNS and eye damage. It is known by very many similar trade names world-wide.

    Which are Vytone UNII Codes?

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

    Which are Vytone 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 Vytone?

    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: 1436947 - hydrocortisone acetate 1.9 % / iodoquinol 1 % Topical Cream
    • RxCUI: 1436947 - hydrocortisone acetate 19 MG/ML / iodoquinol 10 MG/ML Topical Cream
    • RxCUI: 1436949 - Vytone 1.9 % / 1 % Topical Cream
    • RxCUI: 1436949 - hydrocortisone acetate 19 MG/ML / iodoquinol 10 MG/ML Topical Cream [Vytone]
    • RxCUI: 1436949 - Vytone (hydrocortisone acetate 1.9 % / iodoquinol 1 % ) Topical Cream

    Which are the Pharmacologic Classes for Vytone?

    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.

    [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.

    [10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

    [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".