NDC 0121-0676 Potassium Citrate And Citric Acid

Potassium Citrate And Citric Acid Monohydrate Solution Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0121-0676
Proprietary Name:
Potassium Citrate And Citric Acid
Non-Proprietary Name: [1]
Potassium Citrate And Citric Acid Monohydrate
Substance Name: [2]
Citric Acid Monohydrate; Potassium Citrate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Pai Holdings, Llc
    Labeler Code:
    0121
    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]
    10-07-1997
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    RED (C48326)
    Flavor(s):
    BERRY (C73365)

    Product Packages

    NDC Code 0121-0676-16

    Package Description: 473 mL in 1 BOTTLE

    Price per Unit: $0.06531 per ML

    Product Details

    What is NDC 0121-0676?

    The NDC code 0121-0676 is assigned by the FDA to the product Potassium Citrate And Citric Acid which is a human prescription drug product labeled by Pai Holdings, Llc. The generic name of Potassium Citrate And Citric Acid is potassium citrate and citric acid monohydrate. The product's dosage form is solution and is administered via oral form. The product is distributed in a single package with assigned NDC code 0121-0676-16 473 ml 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 Citrate And Citric Acid?

    Potassium Citrate and Citric Acid Oral Solution USP is an effective alkalinizing agent useful in those conditions where long-term maintenance of an alkaline urine is desirable, such as in patients with uric acid and cystine calculi of the urinary tract, especially when the administration of sodium salts is undesirable or contraindicated. In addition, it is a valuable adjuvant when administered with uricosuric agents in gout therapy, since urates tend to crystallize out of an acid urine. It is also effective in correcting the acidosis of certain renal tubular disorders where the administration of potassium citrate may be preferable. This product is highly concentrated, and when administered after meals and before bedtime, allows one to maintain an alkaline urinary pH around the clock, usually without the necessity of a 2 A.M. dose. This product alkalinizes the urine without producing a systemic alkalosis in recommended dosage. It is highly palatable, pleasant tasting and tolerable, even when administered for long periods. Potassium citrate does not neutralize the gastric juice or disturb digestion.

    What are Potassium Citrate And Citric Acid 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.
    • CITRIC ACID MONOHYDRATE 334 mg/5mL - A key intermediate in metabolism. It is an acid compound found in citrus fruits. The salts of citric acid (citrates) can be used as anticoagulants due to their calcium chelating ability.
    • POTASSIUM CITRATE 1100 mg/5mL - A powder that dissolves in water, which is administered orally, and is used as a diuretic, expectorant, systemic alkalizer, and electrolyte replenisher.

    Which are Potassium Citrate And Citric Acid UNII Codes?

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

    Which are Potassium Citrate And Citric Acid 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 Citrate And Citric Acid?

    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: 309318 - citric acid 334 MG / potassium citrate 1100 MG in 5 mL Oral Solution
    • RxCUI: 309318 - citric acid 66.8 MG/ML / potassium citrate 220 MG/ML Oral Solution
    • RxCUI: 309318 - citric acid 334 MG / potassium citrate 1100 MG per 5 ML Oral Solution
    • RxCUI: 309318 - Citric Acid 66.8 MG/ML / K+ citrate 220 MG/ML Oral Solution
    • RxCUI: 309318 - Citric Acid 66.8 MG/ML / Pot citrate 220 MG/ML Oral Solution

    Which are the Pharmacologic Classes for Potassium Citrate And Citric Acid?

    * 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".