NDC Package 65841-538-05 Potassium Citrate

Tablet, Extended Release Oral - View Billable Units, 11-Digit Format, RxNorm

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:
65841-538-05
Package Description:
500 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code:
Proprietary Name:
Potassium Citrate
Non-Proprietary Name:
Potassium Citrate
Substance Name:
Potassium Citrate
Usage Information:
This medication is used to make the urine less acidic. This effect helps the kidneys get rid of uric acid, thereby helping to prevent gout and kidney stones. This medication can also prevent and treat certain metabolic problems (acidosis) caused by kidney disease. Citric acid and citrate salts (which contain potassium and sodium) belong to a class of drugs known as urinary alkalinizers. If you have a condition that requires you to limit your intake of potassium and sodium, your doctor may direct you to take a product that is lower in potassium and sodium.
11-Digit NDC Billing Format:
65841053805
NDC to RxNorm Crosswalk:
  • RxCUI: 199376 - potassium citrate 5 MEQ Extended Release Oral Tablet
  • RxCUI: 199376 - K+ citrate 5 MEQ Extended Release Oral Tablet
  • RxCUI: 199376 - Pot citrate 5 MEQ Extended Release Oral Tablet
  • RxCUI: 199376 - potassium citrate 540 MG Extended Release Oral Tablet
  • RxCUI: 199381 - potassium citrate 10 MEQ Extended Release Oral Tablet
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Zydus Lifesciences Limited
    Dosage Form:
    Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    ANDA203546
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    08-12-2014
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    65841-538-01100 TABLET, EXTENDED RELEASE in 1 BOTTLE
    65841-538-0630 TABLET, EXTENDED RELEASE in 1 BOTTLE
    65841-538-101000 TABLET, EXTENDED RELEASE in 1 BOTTLE
    65841-538-1690 TABLET, EXTENDED RELEASE in 1 BOTTLE
    65841-538-3010 BLISTER PACK in 1 CARTON / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 65841-538-05?

    The NDC Packaged Code 65841-538-05 is assigned to a package of 500 tablet, extended release in 1 bottle of Potassium Citrate, a human prescription drug labeled by Zydus Lifesciences Limited. The product's dosage form is tablet, extended release and is administered via oral form.

    Is NDC 65841-538 included in the NDC Directory?

    Yes, Potassium Citrate with product code 65841-538 is active and included in the NDC Directory. The product was first marketed by Zydus Lifesciences Limited on August 12, 2014 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 11-digit format for NDC 65841-538-05?

    The 11-digit format is 65841053805. 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 5-3-2 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
    5-3-265841-538-055-4-265841-0538-05