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  4. NDC Product Code: 83879-001 Premixed Saline Packets

NDC 83879-001 Premixed Saline Packets

Sodium Chloride,Sodium Bicarbonate Granule, For Solution Nasal - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 83879-001?
  4. Premixed Saline Packets Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk
  8. Pharmacologic Classes

Product Information

NDC Product Code:
83879-001
Proprietary Name:
Premixed Saline Packets
Non-Proprietary Name: [1]
Sodium Chloride, Sodium Bicarbonate
Substance Name: [2]
Sodium Bicarbonate; Sodium Chloride
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Granule, For Solution - A small medicinal particle or grain made available in its more stable dry form, to be reconstituted with solvent just before dispensing; the granules are so prepared to contain not only the medicinal agent, but the colorants, flavorants, and any other desired pharmaceutic ingredient.
Administration Route(s): [4]
  • Nasal - Administration to the nose; administered by way of the nose.
    • Labeler Name: [5]
    Shenzhen Kerui Lnt�l Trading Co., Ltd
    Labeler Code:
    83879
    Product Label ID:
    0d11e07b-c137-6efc-e063-6394a90a6bba
    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]
    12-22-2023
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Code Structure Chart

    Product Details

    What is NDC 83879-001?

    The NDC code 83879-001 is assigned by the FDA to the product Premixed Saline Packets which is a human over the counter drug product labeled by Shenzhen Kerui Lnt�l Trading Co., Ltd. The generic name of Premixed Saline Packets is sodium chloride, sodium bicarbonate. The product's dosage form is granule, for solution and is administered via nasal form. The product is distributed in a single package with assigned NDC code 83879-001-01 100 bag in 1 box / 3000 mg in 1 bag. 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 Premixed Saline Packets?

    Adults and children 4 years and over:use 1-2 packets per 8 fl oz (240ml) up to every 2 hours as neededChildren under 4 years:Consult a physicianMixing one saline packet to 8 fl oz (240ml) of water creates an Isotonic saline solution (Hypertonic with 2 saline packets) that is PH balanced and preservative free.Isotonic solution1 saline packet per 8 fl oz (240 ml)Hypertonic solution2 saline packets per 8 fl oz (240 ml)An Isotonic solution has a gentle salt concentration of 9 mg of Sodium Chloride per ml of water, similar to your body's salt level. It can be more comfortable for some initially than a stronger Hypertonic solution.A Hypertonic solution has a higher salt concentration, akin to ocean water's salt content.

    What are Premixed Saline Packets 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 Premixed Saline Packets UNII Codes?

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

    What is the NDC to RxNorm Crosswalk for Premixed Saline Packets?

    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: 1542919 - sodium bicarbonate 700 MG / sodium chloride 2300 MG Powder for Nasal Solution
    • RxCUI: 1542919 - NaHCO3 700 MG / NaCl 2300 MG Powder for Nasal Solution

    Which are the Pharmacologic Classes for Premixed Saline Packets?

    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.

    [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".