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  5. NDC Package Code: 57721-671-05 Amiloride Hydrochloride

NDC Package 57721-671-05 Amiloride Hydrochloride

View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

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:
57721-671-05
Package Description:
500 TABLET in 1 BOTTLE
Product Code:
57721-671
Proprietary Name:
Amiloride Hydrochloride
Usage Information:
Amiloride hydrochloride tablets are indicated as adjunctive treatment with thiazide diuretics or other kaliuretic-diuretic agents in congestive heart failure or hypertension to:a. help restore normal serum potassium levels in patients who develop hypokalemia on the kaliuretic diuretic.b. prevent development of hypokalemia in patients who would be exposed to particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias.The use of potassium-conserving agents is often unnecessary in patients receiving diuretics for uncomplicated essential hypertension when such patients have a normal diet. Amiloride hydrochloride has little additive diuretic or antihypertensive effect when added to a thiazide diuretic.Amiloride hydrochloride tablets should rarely be used alone. It has weak (compared with thiazides) diuretic and antihypertensive effects. Used as single agents, potassium sparing diuretics, including amiloride hydrochloride, result in an increased risk of hyperkalemia (approximately 10% with amiloride). Amiloride hydrochloride tablets should be used alone only when persistent hypokalemia has been documented and only with careful titration of the dose and close monitoring of serum electrolytes.
11-Digit NDC Billing Format:
57721067105
NDC to RxNorm Crosswalk:
  • RxCUI: 977880 - aMILoride HCl 5 MG Oral Tablet
  • RxCUI: 977880 - amiloride hydrochloride 5 MG Oral Tablet
    • Labeler Name:
    Windlas Biotech Limited
    Sample Package:
    No
    Start Marketing Date:
    12-01-2021
    Listing Expiration Date:
    12-31-2023
    Exclude Flag:
    I
    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
    57721-671-01100 TABLET in 1 BOTTLE
    57721-671-0630 TABLET in 1 BOTTLE
    57721-671-101000 TABLET in 1 BOTTLE
    57721-671-1690 TABLET in 1 BOTTLE
    57721-671-3010 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 57721-671-05?

    The NDC Packaged Code 57721-671-05 is assigned to a package of 500 tablet in 1 bottle of Amiloride Hydrochloride, labeled by Windlas Biotech Limited. The product's dosage form is and is administered via form.

    Is NDC 57721-671 included in the NDC Directory?

    No, Amiloride Hydrochloride with product code 57721-671 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Windlas Biotech Limited on December 01, 2021 and its listing in the NDC Directory is set to expire on December 31, 2023 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 57721-671-05?

    The 11-digit format is 57721067105. 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
    5-3-257721-671-055-4-257721-0671-05