Triamterene And Hydrochlorothiazide Capsule
NDC Package 68382-855-10

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 capsules 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 capsules, USP are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone.Triamterene and hydrochlorothiazide capsules, USP are also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked.Triamterene and hydrochlorothiazide capsules, USP may be used alone or as an adjunct to other antihypertensive drugs, such as beta-blockers. This formulation utilizes a capsule delivery system. Marketed by Zydus Pharmaceuticals (usa) Inc., this product is identified by NDC 68382-855 and is authorized under FDA application ANDA208358.

Identification & Billing

NDC Package Code
68382-855-10
Package Description
1000 CAPSULE in 1 BOTTLE
Product Code
68382-855
11-Digit Billing Format
68382085510
RxNorm Crosswalk
  • RxCUI: 198316 - hydroCHLOROthiazide 25 MG / triamterene 37.5 MG Oral Capsule
  • RxCUI: 198316 - hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral Capsule
  • RxCUI: 198316 - HCTZ 25 MG / triamterene 37.5 MG Oral Capsule

Clinical Specifications

Proprietary Name
Triamterene And Hydrochlorothiazide
Non-Proprietary Name
Triamterene And Hydrochlorothiazide
Substance Name
Hydrochlorothiazide; Triamterene
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
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 capsules, USP are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone.Triamterene and hydrochlorothiazide capsules, USP are also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked.Triamterene and hydrochlorothiazide capsules, USP may be used alone or as an adjunct to other antihypertensive drugs, such as beta-blockers. Since triamterene and hydrochlorothiazide capsules, USP may enhance the action of these agents, dosage adjustments may be necessary.

Regulatory & Marketing

Labeler Name
Zydus Pharmaceuticals (usa) Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA208358
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-31-2019
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 (68382-855). Click a package code to view its specific billing and regulatory data.

68382-855-01
100 CAPSULE in 1 BOTTLE
68382-855-05
500 CAPSULE in 1 BOTTLE
68382-855-77
10 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK (68382-855-30)

* 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 68382-855-10 identifies a specific commercial package of 1000 capsule in 1 bottle of Triamterene And Hydrochlorothiazide, a human prescription drug labeled by Zydus Pharmaceuticals (usa) Inc.. This capsule 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 Zydus Pharmaceuticals (usa) Inc. on March 31, 2019. The current certification is valid through December 31, 2026.

How is this Zydus Pharmaceuticals (usa) Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68382085510. 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)
68382-855-10
11-Digit CMS (5-4-2)
68382-0855-10

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