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  4. NDC Product Code: 80830-1693 Potassium Phosphates

NDC 80830-1693 Potassium Phosphates

Potassium Phosphate,Monobasic Potassium Phosphate,Dibasic Injection,Solution, Concentrate - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 80830-1693?
  4. Potassium Phosphates Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes

Product Information

NDC Product Code:
80830-1693
Proprietary Name:
Potassium Phosphates
Non-Proprietary Name: [1]
Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic Injection,
Substance Name: [2]
Potassium Phosphate, Dibasic; Potassium Phosphate, Monobasic
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Solution, Concentrate - A liquid preparation (i.e., a substance that flows readily in its natural state) that contains a drug dissolved in a suitable solvent or mixture of mutually miscible solvents; the drug has been strengthened by the evaporation of its nonactive parts.
Administration Route(s): [4]
  • Intravenous - Administration within or into a vein or veins.
    • Labeler Name: [5]
    Amneal Pharmaceuticals Private Limited
    Labeler Code:
    80830
    Product Label ID:
    89136c51-a60b-4269-bd05-9489f060a734
    FDA Application Number: [6]
    ANDA216344
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    10-23-2023
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
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    Product Details

    What is NDC 80830-1693?

    The NDC code 80830-1693 is assigned by the FDA to the product Potassium Phosphates which is a human prescription drug product labeled by Amneal Pharmaceuticals Private Limited. The generic name of Potassium Phosphates is potassium phosphate, monobasic potassium phosphate, dibasic injection, . The product's dosage form is solution, concentrate and is administered via intravenous form. The product is distributed in 2 packages with assigned NDC codes 80830-1693-3 5 vial, single-dose in 1 carton / 5 ml in 1 vial, single-dose (80830-1693-1), 80830-1693-5 25 vial, single-dose in 1 carton / 5 ml in 1 vial, single-dose (80830-1693-1). 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 Phosphates?

    Potassium phosphates injection is indicated as a source of phosphorus: in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated. for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated.

    What are Potassium Phosphates 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 Potassium Phosphates UNII Codes?

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

    Which are Potassium Phosphates 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 Phosphates?

    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: 1928567 - potassium phosphates (phosphorus 15 MMOL / potassium 22 MEQ) in 5 ML Injection
    • RxCUI: 1928567 - 5 ML dibasic potassium phosphate 236 MG/ML / monobasic potassium phosphate 224 MG/ML Injection
    • RxCUI: 1928567 - 5 ML Dibasic K+ phosphate 236 MG/ML / Monobasic K+ phosphate 224 MG/ML Injection
    • RxCUI: 1928567 - 5 ML Dibasic Pot phosphate 236 MG/ML / Monobasic Pot phosphate 224 MG/ML Injection
    • RxCUI: 1928567 - phosphorus 15 MMOL / potassium 22 MEQ per 5 ML Injection

    Which are the Pharmacologic Classes for Potassium Phosphates?

    * 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".