Potassium Citrate And Citric Acid Solution
NDC Package 0121-0676-16

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Potassium Citrate And Citric Acid (potassium citrate and citric acid monohydrate) solution is 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. This formulation utilizes a solution delivery system. Marketed by Pai Holdings, Llc Dba Pai Pharma, this product is identified by NDC 0121-0676.

Identification & Billing

NDC Package Code
0121-0676-16
Package Description
473 mL in 1 BOTTLE
Product Code
0121-0676
11-Digit Billing Format
00121067616
Billing Unit
C73365
RxNorm Crosswalk
  • 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

Clinical Specifications

Proprietary Name
Potassium Citrate And Citric Acid
Non-Proprietary Name
Potassium Citrate And Citric Acid Monohydrate
Substance Name
Citric Acid Monohydrate; Potassium Citrate
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
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.

Regulatory & Marketing

Labeler Name
Pai Holdings, Llc Dba Pai Pharma
Product Type
Human Prescription Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
10-07-1997
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0121-0676-16 identifies a specific commercial package of 473 ml in 1 bottle of Potassium Citrate And Citric Acid, a human prescription drug labeled by Pai Holdings, Llc Dba Pai Pharma. This solution is formulated for oral use and contains citric acid monohydrate; potassium citrate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Pai Holdings, Llc Dba Pai Pharma on October 07, 1997. The current certification is valid through December 31, 2026.

How is this Pai Holdings, Llc Dba Pai Pharma product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00121067616. Quantities are measured in C73365. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0121-0676-16
11-Digit CMS (5-4-2)
00121-0676-16

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.