Amiloride Hydrochloride And Hydrochlorothiazide Tablet
NDC Package 0555-0483-99

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

Amiloride Hydrochloride And Hydrochlorothiazide tablets are indicated in those patients with hypertension or with congestive heart failure who develop hypokalemia when thiazides or other kaliuretic diuretics are used alone, or in whom maintenance of normal serum potassium levels is considered to be clinically important, 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 and hydrochlorothiazide tablets may be used alone or as an adjunct to other antihypertensive drugs, such as methyldopa or beta blockers. This formulation utilizes a tablet delivery system. Marketed by Teva Pharmaceuticals Usa, Inc., this product is identified by NDC 0555-0483 and is authorized under FDA application ANDA071111.

Identification & Billing

NDC Package Code
0555-0483-99
Package Description
60000 TABLET in 1 PAIL
Product Code
0555-0483
11-Digit Billing Format
00555048399
RxNorm Crosswalk
  • RxCUI: 977883 - aMILoride HCl 5 MG / hydroCHLOROthiazide 50 MG Oral Tablet
  • RxCUI: 977883 - amiloride hydrochloride 5 MG / hydrochlorothiazide 50 MG Oral Tablet
  • RxCUI: 977883 - amiloride hydrochloride 5 MG / HCTZ 50 MG Oral Tablet

Clinical Specifications

Proprietary Name
Amiloride Hydrochloride And Hydrochlorothiazide
Non-Proprietary Name
Amiloride Hydrochloride And Hydrochlorothiazide
Substance Name
Amiloride Hydrochloride; Hydrochlorothiazide
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Amiloride hydrochloride and hydrochlorothiazide tablets are indicated in those patients with hypertension or with congestive heart failure who develop hypokalemia when thiazides or other kaliuretic diuretics are used alone, or in whom maintenance of normal serum potassium levels is considered to be clinically important, 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 and hydrochlorothiazide tablets may be used alone or as an adjunct to other antihypertensive drugs, such as methyldopa or beta blockers. Since amiloride hydrochloride and hydrochlorothiazide enhances the action of these agents, dosage adjustments may be necessary to avoid an excessive fall in blood pressure and other unwanted side effects.The fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked.

Regulatory & Marketing

Labeler Name
Teva Pharmaceuticals Usa, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA071111
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-01-1989
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
N/A

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 (0555-0483). Click a package code to view its specific billing and regulatory data.

0555-0483-02
100 TABLET in 1 BOTTLE
0555-0483-05
1000 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 0555-0483-99 identifies a specific commercial package of 60000 tablet in 1 pail of Amiloride Hydrochloride And Hydrochlorothiazide, a human prescription drug labeled by Teva Pharmaceuticals Usa, Inc.. This tablet is formulated for oral use and contains amiloride hydrochloride; hydrochlorothiazide as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Teva Pharmaceuticals Usa, Inc. on December 01, 1989. The current certification is valid through December 31, 2026.

How is this Teva Pharmaceuticals Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00555048399. 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 (4-4-2)
0555-0483-99
11-Digit CMS (5-4-2)
00555-0483-99

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