NDC 0310-1105 Lokelma

Sodium Zirconium Cyclosilicate Powder, For Suspension Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0310-1105
Proprietary Name:
Lokelma
Non-Proprietary Name: [1]
Sodium Zirconium Cyclosilicate
Substance Name: [2]
Sodium Zirconium Cyclosilicate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Powder, For Suspension - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a suspension (a liquid preparation containing the solid particles dispersed in the liquid vehicle).
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Astrazeneca Pharmaceuticals Lp
    Labeler Code:
    0310
    FDA Application Number: [6]
    NDA207078
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    09-04-2018
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Packages

    NDC Code 0310-1105-30

    Package Description: 30 PACKET in 1 BOX / 5 g in 1 PACKET (0310-1105-01)

    Price per Unit: $26.19261 per EA

    NDC Code 0310-1105-39

    Package Description: 11 PACKET in 1 BOX / 5 g in 1 PACKET (0310-1105-01)

    Price per Unit: $26.19261 per EA

    Product Details

    What is NDC 0310-1105?

    The NDC code 0310-1105 is assigned by the FDA to the product Lokelma which is a human prescription drug product labeled by Astrazeneca Pharmaceuticals Lp. The generic name of Lokelma is sodium zirconium cyclosilicate. The product's dosage form is powder, for suspension and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 0310-1105-30 30 packet in 1 box / 5 g in 1 packet (0310-1105-01), 0310-1105-39 11 packet in 1 box / 5 g in 1 packet (0310-1105-01). 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 Lokelma?

    This medication is used to treat high levels of potassium in the blood. It works by binding to potassium in the gut. This medication does not work right away, and should not be used to treat life-threatening high levels of potassium. High potassium levels can cause symptoms such as nausea, muscle weakness/tiredness, irregular heartbeats, or paralysis.

    What are Lokelma 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 Lokelma UNII Codes?

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

    What is the NDC to RxNorm Crosswalk for Lokelma?

    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: 2047633 - sodium zirconium cyclosilicate 5 GM Powder for Oral Suspension
    • RxCUI: 2047633 - sodium zirconium cyclosilicate 5000 MG Powder for Oral Suspension
    • RxCUI: 2047639 - LOKELMA 5 GM Powder for Oral Suspension
    • RxCUI: 2047639 - sodium zirconium cyclosilicate 5000 MG Powder for Oral Suspension [Lokelma]
    • RxCUI: 2047639 - Lokelma 5 GM Powder for Oral Suspension

    * Please review the disclaimer below.

    Patient Education

    Sodium Zirconium Cyclosilicate


    Sodium zirconium cyclosilicate is used to treat hyperkalemia (high levels of potassium in the blood). Sodium zirconium cyclosilicate is not used for emergency treatment of life-threatening hyperkalemia because it takes some time to work. Sodium zirconium cyclosilicate is in a class of medications called potassium removing agents. It works by removing excess potassium from the body.
    [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".