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  5. NDC Package Code: 0121-0676-16 Potassium Citrate And Citric Acid

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

Potassium Citrate And Citric Acid Monohydrate Solution Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0121-0676-16
Package Description:
473 mL in 1 BOTTLE
Product Code:
0121-0676
Proprietary Name:
Potassium Citrate And Citric Acid
Non-Proprietary Name:
Potassium Citrate And Citric Acid Monohydrate
Substance Name:
Citric Acid Monohydrate; Potassium Citrate
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.
11-Digit NDC Billing Format:
00121067616
Billing Unit:
C73365
NDC to 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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Pai Holdings, Llc
    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):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • CITRIC ACID MONOHYDRATE 334 mg/5mL
  • POTASSIUM CITRATE 1100 mg/5mL
    • Pharmacologic Class(es):
  • Acidifying Activity - [MoA] (Mechanism of Action)
  • Acidifying Activity - [MoA] (Mechanism of Action)
  • Anti-coagulant - [EPC] (Established Pharmacologic Class)
  • Calcium Chelating Activity - [MoA] (Mechanism of Action)
  • Calculi Dissolution Agent - [EPC] (Established Pharmacologic Class)
  • Decreased Coagulation Factor Activity - [PE] (Physiologic Effect)
    • Sample Package:
    No
    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 Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 0121-0676-16?

    The NDC Packaged Code 0121-0676-16 is assigned to a package of 473 ml in 1 bottle of Potassium Citrate And Citric Acid, a human prescription drug labeled by Pai Holdings, Llc. The product's dosage form is solution and is administered via oral form.

    Is NDC 0121-0676 included in the NDC Directory?

    Yes, Potassium Citrate And Citric Acid with product code 0121-0676 is active and included in the NDC Directory. The product was first marketed by Pai Holdings, Llc on October 07, 1997 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0121-0676-16?

    The contents of this package are billed C73365

    What is the 11-digit format for NDC 0121-0676-16?

    The 11-digit format is 00121067616. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20121-0676-165-4-200121-0676-16