Amiloride Hydrochloride
NDC Package 57721-671-30

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
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.

Amiloride Hydrochloride is tablets are indicated as adjunctive treatment with thiazide diuretics or other kaliuretic-diuretic agents in congestive heart failure or hypertension to:a. Marketed by Windlas Biotech Limited, this product is identified by NDC 57721-671 and is authorized under FDA application ANDA204180.

Identification & Billing

NDC Package Code
57721-671-30
Package Description
10 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK
Product Code
57721-671
11-Digit Billing Format
57721067130
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Amiloride Hydrochloride
Dosage Form
-
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.

Regulatory & Marketing

Labeler Name
Windlas Biotech Limited
FDA Application #
ANDA204180
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-01-2021
Listing Expiration
12-31-2023
Exclude Flag
I
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (57721-671). Click a package code to view its specific billing and regulatory data.

57721-671-01
100 TABLET in 1 BOTTLE
57721-671-05
500 TABLET in 1 BOTTLE
57721-671-06
30 TABLET in 1 BOTTLE
57721-671-10
1000 TABLET in 1 BOTTLE
57721-671-16
90 TABLET in 1 BOTTLE

* 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 57721-671-30 identifies a specific commercial package of 10 blister pack in 1 carton / 10 tablet in 1 blister pack of Amiloride Hydrochloride, labeled by Windlas Biotech Limited. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Windlas Biotech Limited on December 01, 2021. The current certification is valid through December 31, 2023.

How is this Windlas Biotech Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57721067130. 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 (5-3-2)
57721-671-30
11-Digit CMS (5-4-2)
57721-0671-30

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