Triamterene And Hydrochlorothiazide Tablet
NDC Package 0591-0348-01

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

Triamterene And Hydrochlorothiazide tablets is this 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.Triamterene and hydrochlorothiazide tablets are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. This formulation utilizes a tablet delivery system. Marketed by Actavis Pharma, Inc., this product is identified by NDC 0591-0348 and is authorized under FDA application ANDA071851.

Identification & Billing

NDC Package Code
0591-0348-01
Package Description
100 TABLET in 1 BOTTLE, PLASTIC
Product Code
0591-0348
11-Digit Billing Format
00591034801
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk
  • RxCUI: 310812 - triamterene 37.5 MG / hydroCHLOROthiazide 25 MG Oral Tablet
  • RxCUI: 310812 - hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral Tablet
  • RxCUI: 310812 - HCTZ 25 MG / triamterene 37.5 MG Oral Tablet
  • RxCUI: 310818 - triamterene 75 MG / hydroCHLOROthiazide 50 MG Oral Tablet
  • RxCUI: 310818 - hydrochlorothiazide 50 MG / triamterene 75 MG Oral Tablet

Clinical Specifications

Proprietary Name
Triamterene And Hydrochlorothiazide
Non-Proprietary Name
Triamterene And Hydrochlorothiazide
Substance Name
Hydrochlorothiazide; Triamterene
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
This 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.Triamterene and hydrochlorothiazide tablets are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. Triamterene and hydrochlorothiazide is also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked (e.g., patients on concomitant digitalis preparations, or with a history of cardiac arrhythmias, etc.).Triamterene and hydrochlorothiazide may be used alone or in combination with other antihypertensive drugs such as beta-blockers. Since triamterene and hydrochlorothiazide may enhance the actions of these drugs, dosage adjustments may be necessary.

Regulatory & Marketing

Labeler Name
Actavis Pharma, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA071851
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-23-1993
Listing Expiration
12-31-2026
Exclude Flag
N
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 (0591-0348). Click a package code to view its specific billing and regulatory data.

0591-0348-00
24900 TABLET in 1 BAG
0591-0348-05
500 TABLET in 1 BOTTLE, PLASTIC
0591-0348-10
1000 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 0591-0348-01 identifies a specific commercial package of 100 tablet in 1 bottle, plastic of Triamterene And Hydrochlorothiazide, a human prescription drug labeled by Actavis Pharma, Inc.. This tablet is formulated for oral use and contains hydrochlorothiazide; triamterene 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 Actavis Pharma, Inc. on September 23, 1993. The current certification is valid through December 31, 2026.

How is this Actavis Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00591034801. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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 (4-4-2)
0591-0348-01
11-Digit CMS (5-4-2)
00591-0348-01

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