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  4. NDC Product Code: 64380-881 Sevelamer Carbonate

NDC 64380-881 Sevelamer Carbonate

For Suspension Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 64380-881?
  5. Sevelamer Carbonate Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes

Product Information

NDC Product Code:
64380-881
Proprietary Name:
Sevelamer Carbonate
Non-Proprietary Name: [1]
Sevelamer Carbonate
Substance Name: [2]
Sevelamer Carbonate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
For Suspension - A product, usually a solid, intended for suspension prior to administration.
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:
    c17bff97-8347-43f8-822e-1cb9736562b6
    FDA Application Number: [6]
    ANDA211917
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    02-02-2024
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    YELLOW (C48330 - PALE YELLOW)
    Flavor(s):
    TUTTI FRUTTI (C73420)

    Code Structure Chart

    Product Details

    What is NDC 64380-881?

    The NDC code 64380-881 is assigned by the FDA to the product Sevelamer Carbonate which is a human prescription drug product labeled by Strides Pharma Science Limited. The product's dosage form is for suspension and is administered via oral form. The product is distributed in a single package with assigned NDC code 64380-881-80 90 packet in 1 carton / 2400 mg in 1 packet (64380-881-00). 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 Sevelamer Carbonate?

    Sevelamer is used to lower high blood phosphorus (phosphate) levels in patients who are on dialysis due to severe kidney disease. Dialysis removes some phosphate from your blood, but it is difficult to remove enough to keep your phosphate levels balanced. Decreasing blood phosphate levels can help keep your bones strong, prevent unsafe buildup of minerals in your body, and possibly decrease the risk of heart disease and strokes that can result from high phosphate levels. Sevelamer works by holding onto phosphate from the diet so that it can pass out of your body.

    What are Sevelamer Carbonate 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 Sevelamer Carbonate UNII Codes?

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

    Which are Sevelamer Carbonate 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 Sevelamer Carbonate?

    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: 861370 - sevelamer carbonate 2.4 GM Powder for Oral Suspension
    • RxCUI: 861370 - sevelamer carbonate 2400 MG Powder for Oral Suspension
    • RxCUI: 861375 - sevelamer carbonate 0.8 GM Powder for Oral Suspension
    • RxCUI: 861375 - sevelamer carbonate 800 MG Powder for Oral Suspension

    Which are the Pharmacologic Classes for Sevelamer Carbonate?

    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.

    [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".