Triamterene Capsule
NDC Package 72888-504-01

11-digit billing NDC: 72888050401
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Triamterene capsules are indicated in the treatment of edema associated with congestive heart failure, cirrhosis of the liver and the nephrotic syndrome; steroid- induced edema, idiopathic edema and edema due to secondary hyperaldosteronism.Triamterene Capsules may be used alone or with other diuretics, either for its added diuretic effect or its potassium-sparing potential. This formulation utilizes a capsule delivery system. Marketed by Advagen Pharma Ltd, this product is identified by NDC 72888-504 and is authorized under FDA application ANDA220782.

Identification & Billing

NDC Package Code
72888-504-01
Package Description
100 CAPSULE in 1 BOTTLE
Product Code
72888-504
11-Digit Billing Format
72888050401

Clinical Specifications

Proprietary Name
Triamterene
Non-Proprietary Name
Triamterene
Substance Name
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)
TRIAMTERENE 100 mg/1
Pharmacologic Class
Usage Information
Triamterene Capsules are indicated in the treatment of edema associated with congestive heart failure, cirrhosis of the liver and the nephrotic syndrome; steroid- induced edema, idiopathic edema and edema due to secondary hyperaldosteronism.Triamterene Capsules may be used alone or with other diuretics, either for its added diuretic effect or its potassium-sparing potential. It also promotes increased diuresis when patients prove resistant or only partially responsive to thiazides or other diuretics because of secondary hyperaldosteronism.Usage in Pregnancy. The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Diuretics are indicated in pregnancy (however, see PRECAUTIONSbelow) when edema is due to pathologic causes, just as they are in the absence of pregnancy. Dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may provide relief and may be appropriate.

Regulatory & Marketing

Labeler Name
Advagen Pharma Ltd
Product Type
Human Prescription Drug
FDA Application #
ANDA220782
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-28-2026
Listing Expiration
12-31-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 72888-504-01 identifies a specific commercial package of 100 capsule in 1 bottle of Triamterene, a human prescription drug labeled by Advagen Pharma Ltd. This capsule is formulated for oral use and contains 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 Advagen Pharma Ltd on October 28, 2026. The current certification is valid through December 31, 2027.

How is this Advagen Pharma Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72888050401. 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)
72888-504-01
11-Digit CMS (5-4-2)
72888-0504-01

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