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  4. NDC Product Code: 0121-0595 Sodium Citrate And Citric Acid

NDC 0121-0595 Sodium Citrate And Citric Acid

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

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0121-0595?
  5. Sodium Citrate And Citric Acid Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes

Product Information

Get all the details for National Drug Code (NDC) 0121-0595 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
0121-0595
Proprietary Name:
Sodium Citrate And Citric Acid
Non-Proprietary Name: [1]
Sodium Citrate And Citric Acid Monohydrate
Substance Name: [2]
Anhydrous Citric Acid; Sodium 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]
Pharmaceutical Associates, Inc.
Labeler Code:
0121
Product Label ID:
63201a61-6ac5-41ae-8b2d-ff0d3a8ddfd5
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]
01-01-1969
Listing Expiration Date: [11]
12-31-2025
Exclude Flag: [12]
N
Code Navigator:

Product Characteristics

Flavor(s):
GRAPE (C73391)

Code Structure Chart

Product Details

What is NDC 0121-0595?

The NDC code 0121-0595 is assigned by the FDA to the product Sodium Citrate And Citric Acid which is a human prescription drug product labeled by Pharmaceutical Associates, Inc.. The generic name of Sodium Citrate And Citric Acid is sodium citrate and citric acid monohydrate. The product's dosage form is solution and is administered via oral form. The product is distributed in 3 packages with assigned NDC codes 0121-0595-00 10 tray in 1 case / 10 cup, unit-dose in 1 tray / 15 ml in 1 cup, unit-dose (0121-0595-15), 0121-0595-16 473 ml in 1 bottle , 0121-0595-30 10 tray in 1 case / 10 cup, unit-dose in 1 tray / 30 ml in 1 cup, unit-dose. 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 Sodium Citrate And Citric Acid?

Sodium Citrate and Citric Acid Oral Solution USP is an effective alkalinizing agent. It is useful in those conditions where long-term maintenance of an alkaline urine is desirable, and is of value in the alleviation of chronic metabolic acidosis, such as results from chronic renal insufficiency or the syndrome of renal tubular acidosis, especially when the administration of potassium salts is undesirable or contraindicated. This product is also useful for buffering and neutralizing gastric hydrochloric acid quickly and effectively.Sodium Citrate and Citric Acid Oral Solution USP is 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 the recommended dosage. This product is highly palatable, pleasant tasting, and tolerable, even when administered for long periods.

What are Sodium 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.
  • ANHYDROUS CITRIC ACID 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.
  • SODIUM CITRATE 500 mg/5mL - Sodium salts of citric acid that are used as buffers and food preservatives. They are used medically as anticoagulants in stored blood, and for urine alkalization in the prevention of KIDNEY STONES.

Which are Sodium Citrate And Citric Acid UNII Codes?

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

Which are Sodium 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 Sodium 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: 543014 - citric acid 334 MG / sodium citrate 500 MG in 5 mL Oral Solution
  • RxCUI: 543014 - citric acid 66.8 MG/ML / sodium citrate 100 MG/ML Oral Solution
  • RxCUI: 543014 - citric acid 1002 MG / sodium citrate 1500 MG per 15 ML Oral Solution
  • RxCUI: 543014 - citric acid 2004 MG / sodium citrate 3000 MG per 30 ML Oral Solution
  • RxCUI: 543014 - citric acid 334 MG / sodium citrate 500 MG per 5 ML Oral Solution

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

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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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".