Dyrenium
NDC Package 65197-002-01
Package Information
Dyrenium is triamterene is a "water pill" (diuretic) that works in your kidneys to increase the amount of urine you make. Marketed by Wellspring Pharmaceutical Corporation, this product is identified by NDC 65197-002 and is authorized under FDA application NDA013174.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 65197 - Wellspring Pharmaceutical Corporation
- 65197-002 - Dyrenium
- 65197-002-01 - 100 CAPSULE in 1 BOTTLE
- 65197-002 - Dyrenium
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 (65197-002). Click a package code to view its specific billing and regulatory data.
* 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 65197-002-01 identifies a specific commercial package of 100 capsule in 1 bottle of Dyrenium, labeled by Wellspring Pharmaceutical Corporation. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 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 Wellspring Pharmaceutical Corporation on October 01, 1999. The current certification is valid through December 31, 2019.
What are the primary indications for this medication?
Triamterene is a "water pill" (diuretic) that works in your kidneys to increase the amount of urine you make. This helps your body get rid of extra water. This medication is used to decrease swelling (edema) caused by conditions such as cancer, congestive heart failure, liver disease, and kidney disease. This effect can help your kidneys work better and lessen symptoms such as trouble breathing and swelling in your ankles, feet, hands, or belly.
How is this Wellspring Pharmaceutical Corporation product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 65197000201. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
