Amiloride Hydrochloride
NDC Package 54868-5214-2

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 amiloride HCl is indicated as adjunctive treatment with thiazide diuretics or other kaliuretic-diuretic agents in congestive heart failure or hypertension to:help restore normal serum potassium levels in patients who develop hypokalemia on the kaliuretic diureticprevent 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. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-5214 and is authorized under FDA application NDA018200.

Identification & Billing

NDC Package Code
54868-5214-2
Package Description
30 TABLET in 1 BOTTLE, PLASTIC
Product Code
54868-5214
11-Digit Billing Format
54868521402
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Amiloride Hydrochloride
Dosage Form
-
Usage Information
Amiloride HCl is indicated as adjunctive treatment with thiazide diuretics or other kaliuretic-diuretic agents in congestive heart failure or hypertension to:help restore normal serum potassium levels in patients who develop hypokalemia on the kaliuretic diureticprevent 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 HCl has little additive diuretic or antihypertensive effect when added to a thiazide diuretic.Amiloride HCl should rarely be used alone. It has weak (compared with thiazides) diuretic and antihypertensive effects. Used as single agents, potassium sparing diuretics, including amiloride HCl, result in an increased risk of hyperkalemia (approximately 10% with amiloride). Amiloride HCl 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
Physicians Total Care, Inc.
FDA Application #
NDA018200
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-28-2005
Listing Expiration
12-31-2017
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 (54868-5214). Click a package code to view its specific billing and regulatory data.

54868-5214-0
60 TABLET in 1 BOTTLE, PLASTIC
54868-5214-1
20 TABLET in 1 BOTTLE, PLASTIC
54868-5214-3
10 TABLET in 1 BOTTLE, PLASTIC

* 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 54868-5214-2 identifies a specific commercial package of 30 tablet in 1 bottle, plastic of Amiloride Hydrochloride, labeled by Physicians Total Care, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. 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 Physicians Total Care, Inc. on January 28, 2005. The current certification is valid through December 31, 2017.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868521402. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. 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 (5-4-1)
54868-5214-2
11-Digit CMS (5-4-2)
54868-5214-02

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