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  4. NDC Product Code: 82098-008 Rayasore Kit

NDC 82098-008 Rayasore Kit

Silver Sulfadiazine Kit Topical - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 82098-008?
  4. Rayasore Kit Uses
  5. Active Ingredients UNII Codes
  6. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
82098-008
Proprietary Name:
Rayasore Kit
Non-Proprietary Name: [1]
Silver Sulfadiazine
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
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]
    Raya Pharmaceuticals Llc
    Labeler Code:
    82098
    Product Label ID:
    4b2b1c32-0cea-4978-bd40-e69b97fd432c
    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]
    08-23-2022
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Code Structure Chart

    Product Details

    What is NDC 82098-008?

    The NDC code 82098-008 is assigned by the FDA to the product Rayasore Kit which is a human prescription drug product labeled by Raya Pharmaceuticals Llc. The generic name of Rayasore Kit is silver sulfadiazine. The product's dosage form is kit and is administered via topical form. The product is distributed in a single package with assigned NDC code 82098-008-50 1 kit in 1 carton * 50 g in 1 tube. 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 Rayasore Kit?

    This medication is used with other treatments to help prevent and treat wound infections in patients with serious burns. Silver sulfadiazine works by stopping the growth of bacteria that may infect an open wound. This helps to decrease the risk of the bacteria spreading to surrounding skin, or to the blood where it can cause a serious blood infection (sepsis). Silver sulfadiazine belongs to a class of drugs known as sulfa antibiotics. Silver sulfadiazine must not be used on premature babies or on newborns during the first 2 months of life because of the risk of serious side effects.

    Which are Rayasore Kit UNII Codes?

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

    What is the NDC to RxNorm Crosswalk for Rayasore Kit?

    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:

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    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.

    [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.

    [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".