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  2. Strides Pharma Science Limited
  3. NDC Product Code: 64380-860 Potassium Chloride

NDC 64380-860 Potassium Chloride

Tablet, Extended Release Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

    1. Product Information
    2. Product Packages
    3. Product Characteristics
    4. What is NDC 64380-860?
    5. Potassium Chloride Uses
    6. Active Ingredients
    7. Active Ingredients UNII Codes
    8. Inactive Ingredients UNII Codes
    9. NDC to RxNorm Crosswalk
    10. Pharmacologic Classes
    11. Patient Education

Product Information

NDC Product Code:
64380-860
Proprietary Name:
Potassium Chloride
Non-Proprietary Name: [1]
Potassium Chloride
Substance Name: [2]
Potassium Chloride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Strides Pharma Science Limited
    Labeler Code:
    64380
    Product Label ID:
    0224e5b3-3c49-4e6e-aa78-1abcc6969246
    FDA Application Number: [6]
    ANDA210733
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    11-19-2018
    Listing Expiration Date: [11]
    12-31-2023
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    BLUE (C48333)
    Shape:
    ROUND (C48348)
    Size(s):
    11 MM
    Imprint(s):
    P8
    Score:
    1

    Product Packages

    NDC Code 64380-860-06

    Package Description: 100 TABLET, EXTENDED RELEASE in 1 BOTTLE

    Price per Unit: $0.13275 per EA

    NDC Code 64380-860-07

    Package Description: 500 TABLET, EXTENDED RELEASE in 1 BOTTLE

    Price per Unit: $0.13275 per EA

    NDC Code 64380-860-08

    Package Description: 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE

    Price per Unit: $0.13275 per EA

    Product Details

    What is NDC 64380-860?

    The NDC code 64380-860 is assigned by the FDA to the product Potassium Chloride which is a human prescription drug product labeled by Strides Pharma Science Limited. The product's dosage form is tablet, extended release and is administered via oral form. The product is distributed in 3 packages with assigned NDC codes 64380-860-06 100 tablet, extended release in 1 bottle , 64380-860-07 500 tablet, extended release in 1 bottle , 64380-860-08 1000 tablet, extended release in 1 bottle . 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 Potassium Chloride?

    This medication is a mineral supplement used to treat or prevent low amounts of potassium in the blood. A normal level of potassium in the blood is important. Potassium helps your cells, kidneys, heart, muscles, and nerves work properly. Most people get enough potassium by eating a well-balanced diet. Some conditions that can lower your body's potassium level include severe prolonged diarrhea and vomiting, hormone problems such as hyperaldosteronism, or treatment with "water pills"/diuretics.

    What are Potassium Chloride 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.
    • POTASSIUM CHLORIDE 600 mg/1 - A white crystal or crystalline powder used in BUFFERS; FERTILIZERS; and EXPLOSIVES. It can be used to replenish ELECTROLYTES and restore WATER-ELECTROLYTE BALANCE in treating HYPOKALEMIA.

    Which are Potassium Chloride UNII Codes?

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

    Which are Potassium Chloride 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 Potassium Chloride?

    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: 312529 - potassium chloride 8 MEQ (600 MG) Extended Release Oral Tablet
    • RxCUI: 312529 - potassium chloride 8 MEQ Extended Release Oral Tablet
    • RxCUI: 312529 - K+ Chloride 8 MEQ Extended Release Oral Tablet
    • RxCUI: 312529 - Pot Chloride 8 MEQ Extended Release Oral Tablet
    • RxCUI: 312529 - potassium chloride 600 MG Extended Release Oral Tablet

    Which are the Pharmacologic Classes for Potassium Chloride?

    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.

    Patient Education

    Potassium


    Potassium is essential for the proper functioning of the heart, kidneys, muscles, nerves, and digestive system. Usually the food you eat supplies all of the potassium you need. However, certain diseases (e.g., kidney disease and gastrointestinal disease with vomiting and diarrhea) and drugs, especially diuretics ('water pills'), remove potassium from the body. Potassium supplements are taken to replace potassium losses and prevent potassium deficiency. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
    [Learn More]


    * 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".